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CompletedNCT05298254Updated Nov 9, 2026Results posted

A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

A Phase 1/2 interventional study of 40 µg gE-gI and 80 µg gE-gI in Herpes Simplex, sponsored by GlaxoSmithKline. Completed at 29 sites in 8 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Primary conditionHerpes GenitalisRegistry: Herpes SimplexReclassifiedWhy we changed it
Registry
Herpes Simplex — the first condition term the registry derived for this study.
ClinicalTrials.gg
Herpes Genitalis
Why
  1. The study's title name Herpes Genitalis, a narrower term within Herpes Simplex.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment

Updated Nov 9, 2026Results postedStudy documents posted+5 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this first-time-in-human (FTiH) study was to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study was conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.

02

Conditions studied

  • Herpes Simplex

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Keywords

  • First Time in Human
  • Healthy participants
  • Recurrent genital herpes
  • Herpes Simplex Virus
  • Reactogenicity
  • Safety
  • Immune response
  • Efficacy
03

In context

Herpes Genitalis Reclassified

70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.

This study's enrollment of 504 is above the median of 103 across 51 interventional studies indexed under Herpes Genitalis.

Browse Herpes Genitalis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Compared within Herpes Genitalis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Herpes Simplex. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

The criteria were revised on the registry on Nov 9, 2026. See what changed

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
  2. Written obtained from the participant prior to performance of any study-specific procedure.
  3. Women of non- can be enrolled in the study.

  4. Women of childbearing potential can be enrolled in the study, if the participant:

    • Has practiced highly effective for one month prior to study intervention administration, and,
    • Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and,
    • For PART I: Has agreed to continue highly effective contraception until the end of the study.
    • For PART II: Has agreed to continue highly effective contraception until 3 months after last study intervention administration.
  5. Seronegative for (HIV), as determined by laboratory screening tests. Participants documented to be seropositive to HIV will not be eligible for study participation.
  6. Only for PART I: Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study.
  7. Only for PART I: Man or woman aged 18 to 40 years, included, at the time of the first study intervention administration.
  8. Only for PART I: Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.

  9. Only for PART II: Participants with recurrent genital herpes and with no significant health problems as established by medical history and physical examination, at the discretion of the investigator, before entering the study.

    • Diagnosis of genital herpes for at least one year before the Screening visit.
    • History of self-reported or documented recurrent lesional genital herpes frequency of at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if still on suppressive therapy within 3 months before the Screening visit, prior to initiation of suppressive therapy.
  10. Only for PART II: Man or woman aged 18 to 60 years, included, at the time of the first study intervention administration.
  11. Only for PART II: Seropositive for HSV-2 as determined by serological testingperformed at the Screening visit, or having documented laboratory-confirmed HSV 2 genital herpes (i.e., HSV-2 DNA positive by a molecular technique such as polymerase chain reaction [PCR], or HSV-2 seropositive by a type-specific serology assay such as Western Blot or other immunoassay).Only for PART II (shedding sub-cohort): Participants agreeing to collect 2 swabs per day from anogenital area for the full duration of the 5 swabbing periods planned in the study.
  12. Only for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period.
  13. Only for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period. This criterion can only be checked at Visit 1 (Day 1).

Exclusion criteria

Exclusion Criteria:

Medical Conditions

  1. Acute or chronic pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  2. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the efficacy and immunogenicity assessments planned in this study.
  3. History of any reaction or likely to be exacerbated by any component of the study intervention.
  4. Any confirmed or suspected or immunodeficient condition, based on medical history and physical examination.
  5. Hypersensitivity to latex.
  6. Recurrent history or uncontrolled neurological disorders or seizures.
  7. Haematological and/or biochemical parameters outside the normal laboratory ranges at the Screening visit, unless the laboratory abnormalities are considered not clinically significant by the investigator.
  8. \< 18 kg/m\^2 or > 35 kg/m\^2.
  9. Past or current Guillain-Barré syndrome.

  10. History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.

    Prior/Concomitant Therapy

  11. Use of any or non-registered product other than the study intervention during the period beginning as of the Screening visit, or planned use during the study period.
  12. Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study intervention administration.
  13. Administration or planned administration of long-acting immune-modifying drugs at any time during the study period.
  14. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period.
  15. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For , this will mean prednisone equivalent >= 20 mg/day, or equivalent. Inhaled, intra articular and topical steroids are allowed.
  16. Prior receipt of another vaccine containing HSV antigens.
  17. Only for PART II: Planned use of suppressive anti-HSV therapy from the Screening visit until the end of the study.
  18. Only for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study.
  19. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.

  20. Only for PART II: Planned use of any episodic antiviral medications during the swabbing periods (including the baseline period) (only for the shedding sub-cohort).

    Prior/Concurrent Clinical Study Experience

  21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.

    Other Exclusions

  22. Pregnant or lactating women.
  23. Woman planning to become pregnant or planning to discontinue precautions in the period starting from the Screening visit up to 3 months post-last dose of study intervention.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
504 participants (actual)

Study arms

  • Experimental
    Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)

    Healthy participants received 2 doses of the non-adjuvanted HSVTI (40 µg gE-gI), administered at Day 1 and Day 29.

    Biological: 40 µg gE-gI

  • Experimental
    Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)

    Healthy participants received 2 doses of the non-adjuvanted HSVTI (80 µg gE-gI), administered at Day 1 and at Day 29.

    Biological: 80 µg gE-gI

  • Experimental
    Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)

    Healthy participants received 2 doses of the non-adjuvanted HSVTI (160 µg gE-gI), administered at Day 1 and Day 29.

    Biological: 160 µg gE-gI

  • Experimental
    Part 1: HSVTI (40 µg gE-gI/AS01B)

    Healthy participants received 2 doses of HSVTI (40 µg gE-gI/AS01B), administered at Day 1 and Day 29.

    Biological: 40 µg gE-gI/AS01B

  • Experimental
    Part 1: HSVTI (80 µg gE-gI/AS01B)

    Healthy participants received 2 doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29.

    Biological: 80 µg gE-gI/AS01B

  • Experimental
    Part 1: HSVTI (160 µg gE-gI/AS01B)

    Healthy participants received 2 doses of HSVTI (160 µg gE-gI/AS01B), administered at Day 1 and Day 29.

    Biological: 60 µg gE-gI/AS01B

  • Experimental
    Part 1: HSVTI (40 µg gE-gI/AS01E)

    Healthy participants received 2 doses of HSVTI (40 µg gE-gI/AS01E), administered at Day 1 and Day 29.

    Biological: 40 µg gE-gI/AS01E

  • Experimental
    Part 1: HSVTI (80 µg gE-gI/AS01E)

    Healthy participants received 2 doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29.

    Biological: 80 µg gE-gI/AS01E

  • Experimental
    Part 1: HSVTI (160 µg gE-gI/AS01E)

    Healthy participants received 2 doses of HSVTI (160 µg gE-gI/AS01E), administered at Day 1 and Day 29.

    Biological: 160 µg gE-gI/AS01E

  • Placebo comparator
    Part 1: Placebo

    Healthy participants received placebo as control at Day 1 and Day 29.

    Drug: Placebo

  • Experimental
    Part 2: HSVTI (80 µg gE-gI/AS01B)

    Participants with HSV-2 genital herpes received 2 doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29.

    Biological: 80 µg gE-gI/AS01B

  • Experimental
    Part 2: HSVTI (80 µg gE-gI/AS01E)

    Participants with HSV-2 genital herpes received 2 doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29.

    Biological: 80 µg gE-gI/AS01E

  • Placebo comparator
    Part 2: Placebo

    Participants with HSV-2 genital herpes received placebo as control, at Day 1 and Day 29.

    Drug: Placebo

Interventions

  • Biological40 µg gE-gI

    Two doses of the non-adjuvanted HSVTI (40 µg gE-gI), administered at Day 1 and Day 29.

  • Biological80 µg gE-gI

    Two doses of the non-adjuvanted HSVTI (80 µg gE-gI), administered at Day 1 and at Day 2

  • Biological160 µg gE-gI

    Two doses of the non-adjuvanted HSVTI (160 µg gE-gI), administered at Day 1 and Day 29.

  • Biological40 µg gE-gI/AS01B

    Two doses of HSVTI (40 µg gE-gI/AS01B), administered at Day 1 and Day 29.

  • Biological80 µg gE-gI/AS01B

    Two doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29.

  • Biological60 µg gE-gI/AS01B

    Two doses of HSVTI (160 µg gE-gI/AS01B), administered at Day 1 and Day 29.

  • Biological40 µg gE-gI/AS01E

    Two doses of HSVTI (40 µg gE-gI/AS01E), administered at Day 1 and Day 29.

  • Biological80 µg gE-gI/AS01E

    Two doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29.

  • Biological160 µg gE-gI/AS01E

    Two doses of HSVTI (160 µg gE-gI/AS01E), administered at Day 1 and Day 29.

  • DrugPlacebo

    Two doses of Placebo administered on Day 1 and Day 29.

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants With Solicited Administration Site Events

    The solicited administration site events assessed were erythema, pain and swelling.

    Time frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  2. Part 2: Number of Participants With Solicited Administration Site Events

    The solicited administration site events assessed were erythema, pain and swelling.

    Time frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  3. Part 1: Number of Participants With Solicited Systemic Events

    The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.

    Time frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  4. Part 2: Number of Participants With Solicited Systemic Events

    The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.

    Time frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  5. Part 1: Number of Participants With Unsolicited Adverse Events (AEs)

    An unsolicited AE is an AE that was not included in a list of solicited events using an eDiary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non serious AEs.

    Time frame: During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  6. Part 2: Number of Participants With Unsolicited AEs

    Time frame: During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)

  7. Part 1: Number of Participants With Medically Attended AEs (MAEs)

    An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.

    Time frame: From Day 1 to Day 394

  8. Part 2: Number of Participants With MAEs

    Time frame: From Day 1 to Day 394

  9. Part 1: Number of Participants With Serious AEs (SAEs)

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.

    Time frame: From Day 1 to Day 394

  10. Part 2: Number of Participants With SAEs

    Time frame: From Day 1 to Day 394

  11. Part 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)

    pIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology.

    Time frame: From Day 1 to Day 394

  12. Part 2: Number of Participants With pIMDs

    Time frame: From Day 1 to Day 394

  13. Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8

    The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 8

  14. Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29

    The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 29

  15. Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36

    The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 36

  16. Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 64

    The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 64 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 64. Row titles indicate the participant's category at baseline and at Day 64, respectively. Categories reported when comparing baseline and Day 64 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 64

  17. Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8

    The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 8

  18. Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29

    The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 29

  19. Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36

    The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 36

  20. Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 57

    The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 57 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 57. Row titles indicate the participant's category at baseline and at Day 57, respectively. Categories reported when comparing baseline and Day 57 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

    Time frame: At Day 57

  21. Part 2: Time to First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH) Episode

    Number of days form Day 43, defined as 14 days after administration of Dose 2 until the onset date of the first patient-reported RGH episode that is confirmed positive for HSV-2 by polymerase chain reaction (PCR) from at least one lesional or anogenital swab collected during that episode.

    Time frame: From Day 43 [14 days post Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)

Secondary outcomes

  1. Part 2: Incidence Rate of PCR- Confirmed HSV-2 RGH Episodes

    Incidence rates of PCR confirmed HSV-2 RGH episodes were calculated as the number of HSV-2 RGH episodes confirmed by PCR divided by the number of person-year, assessed starting from 14 days after Dose 2 until end of RGH event reporting period.

    Time frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)

  2. Part 2: Number of Participants Free From Confirmed HSV-2 RGH Episode

    Number of participants who either did not report any suspected RGH episodes or reported suspected episodes that were all confirmed negative for HSV-2 by PCR.

    Time frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 209 (6 months post-Dose 2)

  3. Part 2: Severity of RGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode Assessed by Herpes Symptoms Checklist (HSC) Total Score

    Severity of symptoms was assessed using the Herpes Symptoms Checklist (HSC), a 13-item questionnaire where participants rate symptom severity on a 4-point scale (0 = no symptom; higher scores indicate greater severity). Total scores range from 0 (no symptoms) to 39 (severe symptoms). At the onset of each confirmed HSV-2 recurrent genital herpes episode, participants completed the HSC once daily until all lesions and symptoms resolved. The analysis summarizes HSC total scores across all fully completed questionnaires during confirmed episodes.

    Time frame: From Day 43 [14 days post-Dose 2 (at Day 29)]to Day 394 (the end of the follow-up phase)

  4. Part 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode

    Number of days with RGH-associated symptoms during each PCR confirmed HSV-2 RGH episode, as reported by participants. Symptoms were recorded daily from onset of recurrence until resolution of lesions. The analysis summarizes episode-level duration across treatment groups.

    Time frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)

  5. Part 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-Year

    Lesion rate was calculated as the number of days with confirmed HSV-2 genital herpes lesions (swelling, blisters, sores, or crusts) divided by the total number of person-year, assessed starting 14 days after Dose 2 until the end of the RGH event reporting period.

    Time frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)

  6. Part 2: HSV-2 Shedding Rate Reduction

    HSV-2 shedding rate was assessed at the overall treatment-group level and was calculated as the total number of HSV-2-positive evaluable anogenital swabs divided by the total number of evaluable anogenital swabs collected during the applicable swabbing period. A Poisson regression model was used to estimate the shedding rate ratio for the 6-week post-Dose 2 swabbing period (Days 43 to 71) relative to baseline (Days -28 to -1). Shedding rate reduction was calculated as 1 minus the model-estimated shedding rate ratio and reported as a decimal with the corresponding 90% confidence interval. Positive values indicate a reduction, and negative values indicate an increase relative to baseline. The outcome was reported using Measure Type "Number" because the result was a model-estimated treatment-group-level reduction rate.

    Time frame: At 6 weeks post-Dose 2 (Day 43 to Day 71) compared to baseline (Day -28 to Day -1)

  7. Part 2: Number of HSV-2 DNA Shedding Episodes

    An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

    Time frame: From start of the baseline (Day -28) up to Day -1

  8. Part 2: Number of HSV-2 DNA Shedding Episodes

    An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

    Time frame: Day 43 to Day 70

  9. Part 2: Duration of HSV-2 DNA Shedding Episodes

    Duration was defined as the number of consecutive days within an HSV-2 DNA shedding episode. An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

    Time frame: From start of the baseline (Day -28) up to Day -1

  10. Part 2: Duration of HSV-2 DNA Shedding Episodes

    Time frame: Day 43 to Day 70

  11. Part 1: Anti-Glycoprotein E/I (gE-gI) Antibody Geometric Mean Concentration (GMC)

    GMC of total IgG antibodies binding to the HSV-2 gE-gI heterodimer, using enzyme-linked immunosorbent assay (ELISA).

    Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394

  12. Part 2: Anti-gE-gI Antibody GMC

    GMC of total IgG antibodies binding to the HSV-2 gE-gI heterodimer, using ELISA.

    Time frame: At Day 1, Day 29 and Day 57

  13. Part 1: Number of Participants With HSV-2 gE-gI Binding Immunoglobulin G (IgG) Concentrations >= 0.99 EU/mL (Seropositive Rate), Assessed by ELISA

    A seropositive participant is a participant whose antibody concentration is greater than or equal to the assay cut-off value (≥ 0.99 EU/mL).

    Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394

  14. Part 2: Number of Participants With HSV-2 gE-gI Binding IgG Concentrations >= 1.38 EU/mL (Seropositive Rate), Assessed by ELISA

    A seropositive participant is defined as one whose HSV-2 gE-gI IgG concentration is ≥ the assay cut-off (0.99 EU/mL), as measured by ELISA.

    Time frame: At Day 1, Day 29 and Day 57

  15. Part 1: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells

    Geometric Mean Frequency of Polypositive gE-gI-Specific CD4⁺ T Cells Expressing \>= 2 Activation Markers (Interferon \[IFN\]-gamma, Tumour necrosis factor \[TNF\]-alpha, Interleukin \[IL\]-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

    Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394

  16. Part 2: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells

    Geometric Mean Frequency of Polypositive gE-gI-Specific CD4⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

    Time frame: At Day 1, Day 29, and Day 57

  17. Part 1: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency

    Geometric Mean Frequency of Polypositive gE-gI-Specific CD8⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

    Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394

  18. Part 2: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency

    Geometric Mean Frequency of Polypositive gE-gI-Specific CD8⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

    Time frame: At Day 1, Day 29, and Day 57

07

Results

Posted Nov 9, 2026

Participant flow

Participant flow — Overall Study
MilestonePart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: PlaceboPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Started25242425242425252520868690
Completed24232124232423232520596664
Not completed1131102200272026
Withdrew: Adverse event0000000000003
Withdrew: Lost to follow-up01201022001039
Withdrew: Withdrawal by subject001000000011710
Withdrew: Migrated / moved from the study area0000000000242
Withdrew: Acknowledgement of failure in primary efficacy analysis0000000000342
Withdrew: Other1001000000120

Outcome measures

PrimaryPart 1: Number of Participants With Solicited Administration Site Events

The solicited administration site events assessed were erythema, pain and swelling.

Time frame:
Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Solicited Administration Site Events
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Erythema, dose 11007331240
Pain, dose 14122422241923221
Swelling, dose 11001010020
Erythema, dose 20014481340
Pain, dose 22222120221615191
Swelling, dose 21011222310
PrimaryPart 2: Number of Participants With Solicited Administration Site Events

The solicited administration site events assessed were erythema, pain and swelling.

Time frame:
Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Solicited Administration Site Events
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Erythema, dose 113120
Pain, dose 1827710
Swelling, dose 11220
Erythema, dose 217120
Pain, dose 2727410
Swelling, dose 2850
PrimaryPart 1: Number of Participants With Solicited Systemic Events

The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.

Time frame:
Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Solicited Systemic Events
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Arthralgia, dose 10112221221
Fatigue, dose 1653910126546
Headache, dose 11135119148889
Myalgia, dose 12239887673
Fever, dose 11002030001
Arthralgia, dose 21117552040
Fatigue, dose 2652151612611106
Headache, dose 2754171216159104
Myalgia, dose 223314151679111
Fever, dose 20014830410
PrimaryPart 2: Number of Participants With Solicited Systemic Events

The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.

Time frame:
Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Solicited Systemic Events
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Arthralgia, dose 126266
Fatigue, dose 1635536
Headache, dose 1525129
Myalgia, dose 1604616
Fever, dose 1661
Arthralgia, dose 229236
Fatigue, dose 2666026
Headache, dose 2565224
Myalgia, dose 2524911
Fever, dose 22061
PrimaryPart 1: Number of Participants With Unsolicited Adverse Events (AEs)

An unsolicited AE is an AE that was not included in a list of solicited events using an eDiary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non serious AEs.

Time frame:
During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Unsolicited Adverse Events (AEs)
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Dose 11411111381512171712
Dose 276111597710169
PrimaryPart 2: Number of Participants With Unsolicited AEs
Time frame:
During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Unsolicited AEs
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Dose 1353035
Dose 2342925
PrimaryPart 1: Number of Participants With Medically Attended AEs (MAEs)

An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.

Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Medically Attended AEs (MAEs)
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Part 1: Number of Participants With Medically Attended AEs (MAEs)16131212161613141513
PrimaryPart 2: Number of Participants With MAEs
Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 2: Number of Participants With MAEs
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Number of Participants With MAEs383344
PrimaryPart 1: Number of Participants With Serious AEs (SAEs)

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.

Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Serious AEs (SAEs)
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Part 1: Number of Participants With Serious AEs (SAEs)0000100310
PrimaryPart 2: Number of Participants With SAEs
Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 2: Number of Participants With SAEs
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Number of Participants With SAEs102
PrimaryPart 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)

pIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology.

Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Part 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)1000001000
PrimaryPart 2: Number of Participants With pIMDs
Time frame:
From Day 1 to Day 394
Reported as:
Count of participants · Participants
Part 2: Number of Participants With pIMDs
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Number of Participants With pIMDs010
PrimaryPart 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8

The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 8
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
ALT — Below (baseline) - below0000000000
ALT — Within (baseline) - below0000000000
ALT — Above (baseline) - below0000000000
ALT — Below (baseline) - within0000000000
ALT — Within (baseline) - within24232322242124242520
ALT — Above (baseline) - within0011001100
ALT — Below (baseline) - above0000000000
ALT — Within (baseline) - above0101010000
ALT — Above (baseline) - above0001020000
ALT — Unknown (baseline) - Within0000000000
AST — Below (baseline) - below0000000000
AST — Within (baseline) - below0000000000
AST — Above (baseline) - below0000000000
AST — Below (baseline) - within0000000000
AST — Within (baseline) - within23232322222324232420
AST — Above (baseline) - within0010201210
AST — Below (baseline) - above0000000000
AST — Within (baseline) - above0102010000
AST — Above (baseline) - above0001000000
AST — Unknown (baseline) - Within0000000000
Creatinine — Below (baseline) - below0000000000
Creatinine — Within (baseline) - below0000000000
Creatinine — Above (baseline) - below0000000000
Creatinine — Below (baseline) - within0000000100
Creatinine — Within (baseline) - within21222125242321232419
Creatinine — Above (baseline) - within0000001000
Creatinine — Below (baseline) - above0000000000
Creatinine — Within (baseline) - above2130012111
Creatinine — Above (baseline) - above1100001000
Creatinine — Unknown (baseline) - Within0000000000
Urea Nitrogen — Below (baseline) - below0000000000
Urea Nitrogen — Within (baseline) - below0000000000
Urea Nitrogen — Above (baseline) - below0000000000
Urea Nitrogen — Below (baseline) - within1000000000
Urea Nitrogen — Within (baseline) - within23232424242224242420
Urea Nitrogen — Above (baseline) - within0100020000
Urea Nitrogen — Below (baseline) - above0000000000
Urea Nitrogen — Within (baseline) - above0001001010
Urea Nitrogen — Above (baseline) - above0000000100
Urea Nitrogen — Unknown (baseline) - Within0000000000
Hemoglobin — Below (baseline) - below4111133310
Hemoglobin — Within (baseline) - below2301131111
Hemoglobin — Above (baseline) - below0000000000
Hemoglobin — Below (baseline) - within0021010200
Hemoglobin — Within (baseline) - within15192020201620192317
Hemoglobin — Above (baseline) - within0000000000
Hemoglobin — Below (baseline) - above0000000000
Hemoglobin — Within (baseline) - above0000000000
Hemoglobin — Above (baseline) - above0000000000
Hemoglobin — Unknown (baseline) - Within0000000000
Lymphocytes — Below (baseline) - below0000000000
Lymphocytes — Within (baseline) - below0000000001
Lymphocytes — Above (baseline) - below0000000000
Lymphocytes — Below (baseline) - within0010100000
Lymphocytes — Within (baseline) - within21232223212324252517
Lymphocytes — Above (baseline) - within0000000000
Lymphocytes — Below (baseline) - above0000000000
Lymphocytes — Within (baseline) - above0000000000
Lymphocytes — Above (baseline) - above0000000000
Lymphocytes — Unknown (baseline) - Within0000000000
Neutrophils — Below (baseline) - below1001000200
Neutrophils — Within (baseline) - below1111002000
Neutrophils — Above (baseline) - below0000000000
Neutrophils — Below (baseline) - within0211020211
Neutrophils — Within (baseline) - within19202120222122212314
Neutrophils — Above (baseline) - within0000000001
Neutrophils — Below (baseline) - above0000000000
Neutrophils — Within (baseline) - above0000000012
Neutrophils — Above (baseline) - above0000000000
Neutrophils — Unknown (baseline) - Within0000000000
Platelets — Below (baseline) - below0000000000
Platelets — Within (baseline) - below0000000000
Platelets — Above (baseline) - below0000000000
Platelets — Below (baseline) - within0000000000
Platelets — Within (baseline) - within20232123212324242517
Platelets — Above (baseline) - within0000100101
Platelets — Below (baseline) - above0000000000
Platelets — Within (baseline) - above1010000000
Platelets — Above (baseline) - above0000000000
Platelets — Unknown (baseline) - Within0010000000
WBC — Below (baseline) - below2101001200
WBC — Within (baseline) - below1001110000
WBC — Above (baseline) - below0000000000
WBC — Below (baseline) - within0111020100
WBC — Within (baseline) - within18212220212023222416
WBC — Above (baseline) - within0000000000
WBC — Below (baseline) - above0000000000
WBC — Within (baseline) - above0000000011
WBC — Above (baseline) - above0000000001
WBC — Unknown (baseline) - Within0000000000
PrimaryPart 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29

The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 29
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
ALT — Below (baseline) - below0000000000
ALT — Within (baseline) - below0000000000
ALT — Above (baseline) - below0000000000
ALT — Below (baseline) - within0000000000
ALT — Within (baseline) - within25231923242222232519
ALT — Above (baseline) - within0011011100
ALT — Below (baseline) - above0000000000
ALT — Within (baseline) - above0120000001
ALT — Above (baseline) - above0001010000
AST — Below (baseline) - below0000000000
AST — Within (baseline) - below0000000000
AST — Above (baseline) - below0000000000
AST — Below (baseline) - within0000000000
AST — Within (baseline) - within25232024222422222420
AST — Above (baseline) - within0011201110
AST — Below (baseline) - above0000000000
AST — Within (baseline) - above0110000000
AST — Above (baseline) - above0000000100
Creatinine — Below (baseline) - below0000000000
Creatinine — Within (baseline) - below0000000000
Creatinine — Above (baseline) - below0000000000
Creatinine — Below (baseline) - within0000000100
Creatinine — Within (baseline) - within23222225242321222419
Creatinine — Above (baseline) - within0000001000
Creatinine — Below (baseline) - above0000000000
Creatinine — Within (baseline) - above1100010111
Creatinine — Above (baseline) - above1100001000
Urea Nitrogen — Below (baseline) - below1000000000
Urea Nitrogen — Within (baseline) - below0000000000
Urea Nitrogen — Above (baseline) - below0000000000
Urea Nitrogen — Below (baseline) - within0000000000
Urea Nitrogen — Within (baseline) - within24222125242223222420
Urea Nitrogen — Above (baseline) - within0100020000
Urea Nitrogen — Below (baseline) - above0000000000
Urea Nitrogen — Within (baseline) - above0110000110
Urea Nitrogen — Above (baseline) - above0000000100
Hemoglobin — Below (baseline) - below4111131210
Hemoglobin — Within (baseline) - below1100230422
Hemoglobin — Above (baseline) - below0000000000
Hemoglobin — Below (baseline) - within0010012300
Hemoglobin — Within (baseline) - within17222021211717152218
Hemoglobin — Above (baseline) - within0000000000
Hemoglobin — Below (baseline) - above0000000000
Hemoglobin — Within (baseline) - above0000000000
Hemoglobin — Above (baseline) - above0000000000
Lymphocytes — Below (baseline) - below0000000000
Lymphocytes — Within (baseline) - below0000100100
Lymphocytes — Above (baseline) - below0000000000
Lymphocytes — Below (baseline) - within0010100000
Lymphocytes — Within (baseline) - within22242122222420232520
Lymphocytes — Above (baseline) - within0000000000
Lymphocytes — Below (baseline) - above0000000000
Lymphocytes — Within (baseline) - above0000000000
Lymphocytes — Above (baseline) - above0000000000
Neutrophils — Below (baseline) - below1200000200
Neutrophils — Within (baseline) - below0221200001
Neutrophils — Above (baseline) - below0000000000
Neutrophils — Below (baseline) - within0012020211
Neutrophils — Within (baseline) - within20201918212219202417
Neutrophils — Above (baseline) - within0000000001
Neutrophils — Below (baseline) - above0000000000
Neutrophils — Within (baseline) - above1001101000
Neutrophils — Above (baseline) - above0000000000
Platelets — Below (baseline) - below0000000000
Platelets — Within (baseline) - below0000000000
Platelets — Above (baseline) - below0000000000
Platelets — Below (baseline) - within0000000000
Platelets — Within (baseline) - within22232022212420232519
Platelets — Above (baseline) - within0000200001
Platelets — Below (baseline) - above0000000000
Platelets — Within (baseline) - above0010100000
Platelets — Above (baseline) - above0000000100
WBC — Below (baseline) - below1202000200
WBC — Within (baseline) - below0410110012
WBC — Above (baseline) - below0000000000
WBC — Below (baseline) - within0011021100
WBC — Within (baseline) - within21182019222119212417
WBC — Above (baseline) - within0000000001
WBC — Below (baseline) - above0000000000
WBC — Within (baseline) - above0000100000
WBC — Above (baseline) - above0000000000
PrimaryPart 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36

The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 36
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
ALT — Below (baseline) - below0000000000
ALT — Within (baseline) - below0000000000
ALT — Above (baseline) - below0000000000
ALT — Below (baseline) - within0000000000
ALT — Within (baseline) - within24232223242223232519
ALT — Above (baseline) - within0011011100
ALT — Below (baseline) - above0000000000
ALT — Within (baseline) - above0100000101
ALT — Above (baseline) - above0001010000
ALT — Unknown (baseline) - Within0000000000
AST — Below (baseline) - below0000000000
AST — Within (baseline) - below0000000000
AST — Above (baseline) - below0000000000
AST — Below (baseline) - within0000000000
AST — Within (baseline) - within23232122222423232420
AST — Above (baseline) - within0010101110
AST — Below (baseline) - above0000000000
AST — Within (baseline) - above0110000000
AST — Above (baseline) - above0001100100
AST — Unknown (baseline) - Within0000000000
Creatinine — Below (baseline) - below0000000000
Creatinine — Within (baseline) - below0000000000
Creatinine — Above (baseline) - below0000000000
Creatinine — Below (baseline) - within0000000100
Creatinine — Within (baseline) - within22232224242322222519
Creatinine — Above (baseline) - within0000001000
Creatinine — Below (baseline) - above0000000000
Creatinine — Within (baseline) - above1011010201
Creatinine — Above (baseline) - above1100001000
Creatinine — Unknown (baseline) - Within0000000000
Urea Nitrogen — Below (baseline) - below1000000000
Urea Nitrogen — Within (baseline) - below0000001000
Urea Nitrogen — Above (baseline) - below0000000000
Urea Nitrogen — Below (baseline) - within0000000000
Urea Nitrogen — Within (baseline) - within23232324242222232519
Urea Nitrogen — Above (baseline) - within0100010000
Urea Nitrogen — Below (baseline) - above0000000000
Urea Nitrogen — Within (baseline) - above0001001101
Urea Nitrogen — Above (baseline) - above0000010100
Urea Nitrogen — Unknown (baseline) - Within0000000000
Hemoglobin — Below (baseline) - below4122143300
Hemoglobin — Within (baseline) - below2102242202
Hemoglobin — Above (baseline) - below0000000000
Hemoglobin — Below (baseline) - within1000001210
Hemoglobin — Within (baseline) - within17222120211618172418
Hemoglobin — Above (baseline) - within0000000000
Hemoglobin — Below (baseline) - above0000000000
Hemoglobin — Within (baseline) - above0000000000
Hemoglobin — Above (baseline) - above0000000000
Hemoglobin — Unknown (baseline) - Within0000000000
Lymphocytes — Below (baseline) - below0000000000
Lymphocytes — Within (baseline) - below0000000000
Lymphocytes — Above (baseline) - below0000000000
Lymphocytes — Below (baseline) - within0010100000
Lymphocytes — Within (baseline) - within24242224232423242520
Lymphocytes — Above (baseline) - within0000000000
Lymphocytes — Below (baseline) - above0000000000
Lymphocytes — Within (baseline) - above0000000000
Lymphocytes — Above (baseline) - above0000000000
Lymphocytes — Unknown (baseline) - Within0000000000
Neutrophils — Below (baseline) - below1100000200
Neutrophils — Within (baseline) - below1001211001
Neutrophils — Above (baseline) - below0000000000
Neutrophils — Below (baseline) - within0112020211
Neutrophils — Within (baseline) - within22222221222122202317
Neutrophils — Above (baseline) - within0000000001
Neutrophils — Below (baseline) - above0000000000
Neutrophils — Within (baseline) - above0000000010
Neutrophils — Above (baseline) - above0000000000
Neutrophils — Unknown (baseline) - Within0000000000
Platelets — Below (baseline) - below0000000000
Platelets — Within (baseline) - below0000000000
Platelets — Above (baseline) - below0000000000
Platelets — Below (baseline) - within0000000000
Platelets — Within (baseline) - within24232224212424232519
Platelets — Above (baseline) - within0000200000
Platelets — Below (baseline) - above0000000000
Platelets — Within (baseline) - above0000100000
Platelets — Above (baseline) - above0000000101
Platelets — Unknown (baseline) - Within0010000000
WBC — Below (baseline) - below2200001000
WBC — Within (baseline) - below1101101000
WBC — Above (baseline) - below0000000000
WBC — Below (baseline) - within0013020300
WBC — Within (baseline) - within21212220232222212319
WBC — Above (baseline) - within0000000001
WBC — Below (baseline) - above0000000000
WBC — Within (baseline) - above0000000020
WBC — Above (baseline) - above0000000000
WBC — Unknown (baseline) - Within0000000000
PrimaryPart 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 64

The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 64 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 64. Row titles indicate the participant's category at baseline and at Day 64, respectively. Categories reported when comparing baseline and Day 64 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 64
Reported as:
Count of participants · Participants
Part 1: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 64
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
ALT — Below (baseline) - below0000000000
ALT — Within (baseline) - below0000000000
ALT — Above (baseline) - below0000000000
ALT — Below (baseline) - within0000000000
ALT — Within (baseline) - within25242323232224242220
ALT — Above (baseline) - within0011021100
ALT — Below (baseline) - above0000000000
ALT — Within (baseline) - above0000000020
ALT — Above (baseline) - above0001000000
ALT — Unknown (baseline) - Within0000000000
AST — Below (baseline) - below0000000000
AST — Within (baseline) - below0000000000
AST — Above (baseline) - below0000000000
AST — Below (baseline) - within0000000000
AST — Within (baseline) - within25242324202424232219
AST — Above (baseline) - within0011201210
AST — Below (baseline) - above0000000000
AST — Within (baseline) - above0000100011
AST — Above (baseline) - above0000000000
AST — Unknown (baseline) - Within0000000000
Creatinine — Below (baseline) - below0000000000
Creatinine — Within (baseline) - below1000000000
Creatinine — Above (baseline) - below0000000000
Creatinine — Below (baseline) - within0000000100
Creatinine — Within (baseline) - within23222323232423222419
Creatinine — Above (baseline) - within0000000000
Creatinine — Below (baseline) - above0000000000
Creatinine — Within (baseline) - above0112000201
Creatinine — Above (baseline) - above1100002000
Creatinine — Unknown (baseline) - Within0000000000
Urea Nitrogen — Below (baseline) - below0000000000
Urea Nitrogen — Within (baseline) - below0000000000
Urea Nitrogen — Above (baseline) - below0000000000
Urea Nitrogen — Below (baseline) - within1000000000
Urea Nitrogen — Within (baseline) - within24232425232225232420
Urea Nitrogen — Above (baseline) - within0100020000
Urea Nitrogen — Below (baseline) - above0000000000
Urea Nitrogen — Within (baseline) - above0000000100
Urea Nitrogen — Above (baseline) - above0000000100
Urea Nitrogen — Unknown (baseline) - Within0000000000
Hemoglobin — Below (baseline) - below4121113210
Hemoglobin — Within (baseline) - below1101122303
Hemoglobin — Above (baseline) - below0000000000
Hemoglobin — Below (baseline) - within1011031300
Hemoglobin — Within (baseline) - within19222122211819172317
Hemoglobin — Above (baseline) - within0000000000
Hemoglobin — Below (baseline) - above0000000000
Hemoglobin — Within (baseline) - above0000000000
Hemoglobin — Above (baseline) - above0000000000
Hemoglobin — Unknown (baseline) - Within0000000000
Lymphocytes — Below (baseline) - below0000000000
Lymphocytes — Within (baseline) - below0010000000
Lymphocytes — Above (baseline) - below0000000000
Lymphocytes — Below (baseline) - within0010100000
Lymphocytes — Within (baseline) - within25242224212425252420
Lymphocytes — Above (baseline) - within0000000000
Lymphocytes — Below (baseline) - above0000000000
Lymphocytes — Within (baseline) - above0000000000
Lymphocytes — Above (baseline) - above0000000000
Lymphocytes — Unknown (baseline) - Within0000000000
Neutrophils — Below (baseline) - below1201010100
Neutrophils — Within (baseline) - below2101111101
Neutrophils — Above (baseline) - below0000000000
Neutrophils — Below (baseline) - within0011010311
Neutrophils — Within (baseline) - within22212221212124202117
Neutrophils — Above (baseline) - within0000000001
Neutrophils — Below (baseline) - above0000000000
Neutrophils — Within (baseline) - above0010000020
Neutrophils — Above (baseline) - above0000000000
Neutrophils — Unknown (baseline) - Within0000000000
Platelets — Below (baseline) - below0000000000
Platelets — Within (baseline) - below0000000000
Platelets — Above (baseline) - below0000000000
Platelets — Below (baseline) - within0000000000
Platelets — Within (baseline) - within25222225212425242419
Platelets — Above (baseline) - within0000200101
Platelets — Below (baseline) - above0000000000
Platelets — Within (baseline) - above0010000000
Platelets — Above (baseline) - above0000000000
Platelets — Unknown (baseline) - Within0010000000
WBC — Below (baseline) - below2200001000
WBC — Within (baseline) - below1101101000
WBC — Above (baseline) - below0000000000
WBC — Below (baseline) - within0013020300
WBC — Within (baseline) - within21212220232222212319
WBC — Above (baseline) - within0000000001
WBC — Below (baseline) - above0000000000
WBC — Within (baseline) - above0000000020
WBC — Above (baseline) - above0000000000
WBC — Unknown (baseline) - Within0000000000
PrimaryPart 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8

The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 8
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 8
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
ALT — Below (baseline) - below000
ALT — Within (baseline) - below000
ALT — Above (baseline) - below000
ALT — Below (baseline) - Within000
ALT — Within (baseline) - Within748076
ALT — Above (baseline) - Within426
ALT — Below (baseline) - Above000
ALT — Within (baseline) - Above202
ALT — Above (baseline) - Above424
AST — Below (baseline) - below000
AST — Within (baseline) - below000
AST — Above (baseline) - below000
AST — Below (baseline) - Within000
AST — Within (baseline) - Within808082
AST — Above (baseline) - Within211
AST — Below (baseline) - Above000
AST — Within (baseline) - Above212
AST — Above (baseline) - Above022
Creatinine — Below (baseline) - below000
Creatinine — Within (baseline) - below000
Creatinine — Above (baseline) - below000
Creatinine — Below (baseline) - Within100
Creatinine — Within (baseline) - Within706978
Creatinine — Above (baseline) - Within221
Creatinine — Below (baseline) - Above000
Creatinine — Within (baseline) - Above364
Creatinine — Above (baseline) - Above975
Urea Nitrogen — Below (baseline) - below000
Urea Nitrogen — Within (baseline) - below101
Urea Nitrogen — Above (baseline) - below000
Urea Nitrogen — Below (baseline) - Within000
Urea Nitrogen — Within (baseline) - Within736971
Urea Nitrogen — Above (baseline) - Within623
Urea Nitrogen — Below (baseline) - Above000
Urea Nitrogen — Within (baseline) - Above366
Urea Nitrogen — Above (baseline) - Above277
Hemoglobin — Below (baseline) - below464
Hemoglobin — Within (baseline) - below365
Hemoglobin — Above (baseline) - below000
Hemoglobin — Below (baseline) - Within832
Hemoglobin — Within (baseline) - Within696876
Hemoglobin — Above (baseline) - Within111
Hemoglobin — Below (baseline) - Above000
Hemoglobin — Within (baseline) - Above000
Hemoglobin — Above (baseline) - Above000
Lymphocytes — Below (baseline) - below001
Lymphocytes — Within (baseline) - below100
Lymphocytes — Above (baseline) - below000
Lymphocytes — Below (baseline) - Within020
Lymphocytes — Within (baseline) - Within838286
Lymphocytes — Above (baseline) - Within000
Lymphocytes — Below (baseline) - Above000
Lymphocytes — Within (baseline) - Above000
Lymphocytes — Above (baseline) - Above000
Neutrophils — Below (baseline) - below114
Neutrophils — Within (baseline) - below113
Neutrophils — Above (baseline) - below000
Neutrophils — Below (baseline) - Within311
Neutrophils — Within (baseline) - Within797978
Neutrophils — Above (baseline) - Within011
Neutrophils — Below (baseline) - Above000
Neutrophils — Within (baseline) - Above010
Neutrophils — Above (baseline) - Above000
Platelets — Below (baseline) - below000
Platelets — Within (baseline) - below000
Platelets — Above (baseline) - below000
Platelets — Below (baseline) - Within000
Platelets — Within (baseline) - Within817885
Platelets — Above (baseline) - Within112
Platelets — Below (baseline) - Above000
Platelets — Within (baseline) - Above120
Platelets — Above (baseline) - Above221
WBC — Below (baseline) - below122
WBC — Within (baseline) - below012
WBC — Above (baseline) - below000
WBC — Below (baseline) - Within133
WBC — Within (baseline) - Within837681
WBC — Above (baseline) - Within010
WBC — Below (baseline) - Above000
WBC — Within (baseline) - Above010
WBC — Above (baseline) - Above000
PrimaryPart 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29

The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 29
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 29
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
ALT — Below (baseline) - below000
ALT — Within (baseline) - below000
ALT — Above (baseline) - below000
ALT — Below (baseline) - Within000
ALT — Within (baseline) - Within697875
ALT — Above (baseline) - Within526
ALT — Below (baseline) - Above000
ALT — Within (baseline) - Above633
ALT — Above (baseline) - Above123
AST — Below (baseline) - below000
AST — Within (baseline) - below000
AST — Above (baseline) - below000
AST — Below (baseline) - Within000
AST — Within (baseline) - Within758182
AST — Above (baseline) - Within112
AST — Below (baseline) - Above000
AST — Within (baseline) - Above412
AST — Above (baseline) - Above021
Creatinine — Below (baseline) - below000
Creatinine — Within (baseline) - below000
Creatinine — Above (baseline) - below000
Creatinine — Below (baseline) - Within100
Creatinine — Within (baseline) - Within687177
Creatinine — Above (baseline) - Within423
Creatinine — Below (baseline) - Above000
Creatinine — Within (baseline) - Above254
Creatinine — Above (baseline) - Above773
Urea Nitrogen — Below (baseline) - below000
Urea Nitrogen — Within (baseline) - below201
Urea Nitrogen — Above (baseline) - below000
Urea Nitrogen — Below (baseline) - Within100
Urea Nitrogen — Within (baseline) - Within677273
Urea Nitrogen — Above (baseline) - Within632
Urea Nitrogen — Below (baseline) - Above000
Urea Nitrogen — Within (baseline) - Above443
Urea Nitrogen — Above (baseline) - Above268
Hemoglobin — Below (baseline) - below564
Hemoglobin — Within (baseline) - below343
Hemoglobin — Above (baseline) - below000
Hemoglobin — Below (baseline) - Within732
Hemoglobin — Within (baseline) - Within657077
Hemoglobin — Above (baseline) - Within011
Hemoglobin — Below (baseline) - Above000
Hemoglobin — Within (baseline) - Above100
Hemoglobin — Above (baseline) - Above000
Lymphocytes — Below (baseline) - below000
Lymphocytes — Within (baseline) - below000
Lymphocytes — Above (baseline) - below000
Lymphocytes — Below (baseline) - Within011
Lymphocytes — Within (baseline) - Within818385
Lymphocytes — Above (baseline) - Within000
Lymphocytes — Below (baseline) - Above000
Lymphocytes — Within (baseline) - Above000
Lymphocytes — Above (baseline) - Above000
Neutrophils — Below (baseline) - below303
Neutrophils — Within (baseline) - below141
Neutrophils — Above (baseline) - below000
Neutrophils — Below (baseline) - Within111
Neutrophils — Within (baseline) - Within767879
Neutrophils — Above (baseline) - Within011
Neutrophils — Below (baseline) - Above000
Neutrophils — Within (baseline) - Above001
Neutrophils — Above (baseline) - Above000
Platelets — Below (baseline) - below000
Platelets — Within (baseline) - below100
Platelets — Above (baseline) - below000
Platelets — Below (baseline) - Within000
Platelets — Within (baseline) - Within778083
Platelets — Above (baseline) - Within322
Platelets — Below (baseline) - Above000
Platelets — Within (baseline) - Above001
Platelets — Above (baseline) - Above011
WBC — Below (baseline) - below212
WBC — Within (baseline) - below411
WBC — Above (baseline) - below000
WBC — Below (baseline) - Within033
WBC — Within (baseline) - Within757880
WBC — Above (baseline) - Within010
WBC — Below (baseline) - Above000
WBC — Within (baseline) - Above001
WBC — Above (baseline) - Above000
PrimaryPart 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36

The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 36
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 36
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
ALT — Below (baseline) - below000
ALT — Within (baseline) - below000
ALT — Above (baseline) - below000
ALT — below (baseline) - Within000
ALT — Within (baseline) - Within717576
ALT — Above (baseline) - Within423
ALT — below (baseline) -Above000
ALT — Within (baseline) -Above124
ALT — Above (baseline) -Above233
AST — Below (baseline) - below000
AST — Within (baseline) - below000
AST — Above (baseline) - below000
AST — below (baseline) - Within000
AST — Within (baseline) - Within727979
AST — Above (baseline) - Within422
AST — below (baseline) -Above000
AST — Within (baseline) -Above104
AST — Above (baseline) -Above011
Creatinine — Below (baseline) - below000
Creatinine — Within (baseline) - below100
Creatinine — Above (baseline) - below000
Creatinine — below (baseline) - Within000
Creatinine — Within (baseline) - Within676873
Creatinine — Above (baseline) - Within531
Creatinine — below (baseline) -Above000
Creatinine — Within (baseline) -Above226
Creatinine — Above (baseline) -Above396
Urea Nitrogen — Below (baseline) - below100
Urea Nitrogen — Within (baseline) - below200
Urea Nitrogen — Above (baseline) - below000
Urea Nitrogen — below (baseline) - Within101
Urea Nitrogen — Within (baseline) - Within646770
Urea Nitrogen — Above (baseline) - Within558
Urea Nitrogen — below (baseline) -Above000
Urea Nitrogen — Within (baseline) -Above454
Urea Nitrogen — Above (baseline) -Above153
Hemoglobin — Below (baseline) - below596
Hemoglobin — Within (baseline) - below378
Hemoglobin — Above (baseline) - below000
Hemoglobin — below (baseline) - Within311
Hemoglobin — Within (baseline) - Within656570
Hemoglobin — Above (baseline) - Within100
Hemoglobin — below (baseline) -Above000
Hemoglobin — Within (baseline) -Above001
Hemoglobin — Above (baseline) -Above000
Lymphocytes — Below (baseline) - below000
Lymphocytes — Within (baseline) - below001
Lymphocytes — Above (baseline) - below000
Lymphocytes — below (baseline) - Within000
Lymphocytes — Within (baseline) - Within778283
Lymphocytes — Above (baseline) - Within000
Lymphocytes — below (baseline) -Above000
Lymphocytes — Within (baseline) -Above000
Lymphocytes — Above (baseline) -Above000
Neutrophils — Below (baseline) - below313
Neutrophils — Within (baseline) - below233
Neutrophils — Above (baseline) - below000
Neutrophils — below (baseline) - Within032
Neutrophils — Within (baseline) - Within717574
Neutrophils — Above (baseline) - Within001
Neutrophils — below (baseline) -Above000
Neutrophils — Within (baseline) -Above101
Neutrophils — Above (baseline) -Above000
Platelets — Below (baseline) - below000
Platelets — Within (baseline) - below000
Platelets — Above (baseline) - below000
Platelets — below (baseline) - Within100
Platelets — Within (baseline) - Within757683
Platelets — Above (baseline) - Within000
Platelets — below (baseline) -Above000
Platelets — Within (baseline) -Above140
Platelets — Above (baseline) -Above012
WBC — Below (baseline) - below312
WBC — Within (baseline) - below102
WBC — Above (baseline) - below000
WBC — below (baseline) - Within211
WBC — Within (baseline) - Within708079
WBC — Above (baseline) - Within001
WBC — below (baseline) -Above000
WBC — Within (baseline) -Above101
WBC — Above (baseline) -Above000
PrimaryPart 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 57

The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 57 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 57. Row titles indicate the participant's category at baseline and at Day 57, respectively. Categories reported when comparing baseline and Day 57 results are defined as follows: Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Time frame:
At Day 57
Reported as:
Count of participants · Participants
Part 2: Number of Participants With Haematological and Biochemical Laboratory Shifts at Day 57
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
ALT — Below (baseline) - below000
ALT — Within (baseline) - below000
ALT — Above (baseline) - below000
ALT — below (baseline) - Within000
ALT — Within (baseline) - Within707375
ALT — Above (baseline) - Within523
ALT — below (baseline) -Above000
ALT — Within (baseline) -Above213
ALT — Above (baseline) -Above132
AST — Below (baseline) - below000
AST — Within (baseline) - below000
AST — Above (baseline) - below000
AST — below (baseline) - Within000
AST — Within (baseline) - Within737278
AST — Above (baseline) - Within311
AST — below (baseline) -Above000
AST — Within (baseline) -Above143
AST — Above (baseline) -Above121
Creatinine — Below (baseline) - below000
Creatinine — Within (baseline) - below000
Creatinine — Above (baseline) - below000
Creatinine — below (baseline) - Within000
Creatinine — Within (baseline) - Within676674
Creatinine — Above (baseline) - Within243
Creatinine — below (baseline) -Above000
Creatinine — Within (baseline) -Above313
Creatinine — Above (baseline) -Above684
Urea Nitrogen — Below (baseline) - below000
Urea Nitrogen — Within (baseline) - below200
Urea Nitrogen — Above (baseline) - below000
Urea Nitrogen — below (baseline) - Within201
Urea Nitrogen — Within (baseline) - Within666369
Urea Nitrogen — Above (baseline) - Within456
Urea Nitrogen — below (baseline) -Above000
Urea Nitrogen — Within (baseline) -Above264
Urea Nitrogen — Above (baseline) -Above254
Hemoglobin — Below (baseline) - below583
Hemoglobin — Within (baseline) - below529
Hemoglobin — Above (baseline) - below000
Hemoglobin — below (baseline) - Within314
Hemoglobin — Within (baseline) - Within636767
Hemoglobin — Above (baseline) - Within100
Hemoglobin — below (baseline) -Above000
Hemoglobin — Within (baseline) -Above001
Hemoglobin — Above (baseline) -Above000
Lymphocytes — Below (baseline) - below000
Lymphocytes — Within (baseline) - below001
Lymphocytes — Above (baseline) - below000
Lymphocytes — below (baseline) - Within000
Lymphocytes — Within (baseline) - Within777782
Lymphocytes — Above (baseline) - Within000
Lymphocytes — below (baseline) -Above000
Lymphocytes — Within (baseline) -Above000
Lymphocytes — Above (baseline) -Above000
Neutrophils — Below (baseline) - below302
Neutrophils — Within (baseline) - below432
Neutrophils — Above (baseline) - below000
Neutrophils — below (baseline) - Within032
Neutrophils — Within (baseline) - Within707076
Neutrophils — Above (baseline) - Within001
Neutrophils — below (baseline) -Above000
Neutrophils — Within (baseline) -Above010
Neutrophils — Above (baseline) -Above000
Platelets — Below (baseline) - below100
Platelets — Within (baseline) - below000
Platelets — Above (baseline) - below000
Platelets — below (baseline) - Within000
Platelets — Within (baseline) - Within747582
Platelets — Above (baseline) - Within001
Platelets — below (baseline) -Above000
Platelets — Within (baseline) -Above020
Platelets — Above (baseline) -Above011
WBC — Below (baseline) - below312
WBC — Within (baseline) - below143
WBC — Above (baseline) - below000
WBC — below (baseline) - Within211
WBC — Within (baseline) - Within717177
WBC — Above (baseline) - Within001
WBC — below (baseline) -Above000
WBC — Within (baseline) -Above010
WBC — Above (baseline) -Above000
PrimaryPart 2: Time to First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH) Episode

Number of days form Day 43, defined as 14 days after administration of Dose 2 until the onset date of the first patient-reported RGH episode that is confirmed positive for HSV-2 by polymerase chain reaction (PCR) from at least one lesional or anogenital swab collected during that episode.

Time frame:
From Day 43 [14 days post Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
Reported as:
Median · days
Part 2: Time to First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH) Episode
daysPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Time to First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH) Episode100.0 (2 to 322)135.0 (1 to 326)125.5 (1 to 331)
Statistical analysis
  • Part 2: HSVTI (80 µg gE-gI/AS01B) vs Part 2: Placebo · Regression, Cox · p = 0.9454 · Hazard ratio (hr): 1.015 · 90% CI 0.710 to 1.451Hazard ratios comparing survival time in days between HSVTI group and placebo.
  • Part 2: HSVTI (80 µg gE-gI/AS01E) vs Part 2: Placebo · Regression, Cox · p = 0.6642 · Hazard ratio (hr): 0.908 · 90% CI 0.629 to 1.310Hazard ratios comparing survival time in days between HSVTI group and placebo was estimated using a Cox proportional hazards model.
SecondaryPart 2: Incidence Rate of PCR- Confirmed HSV-2 RGH Episodes

Incidence rates of PCR confirmed HSV-2 RGH episodes were calculated as the number of HSV-2 RGH episodes confirmed by PCR divided by the number of person-year, assessed starting from 14 days after Dose 2 until end of RGH event reporting period.

Time frame:
From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
Reported as:
Number · Episodes per person-year
Part 2: Incidence Rate of PCR- Confirmed HSV-2 RGH Episodes
Episodes per person-yearPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Incidence Rate of PCR- Confirmed HSV-2 RGH Episodes1.991.791.73
SecondaryPart 2: Number of Participants Free From Confirmed HSV-2 RGH Episode

Number of participants who either did not report any suspected RGH episodes or reported suspected episodes that were all confirmed negative for HSV-2 by PCR.

Time frame:
From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 209 (6 months post-Dose 2)
Reported as:
Count of participants · Participants
Part 2: Number of Participants Free From Confirmed HSV-2 RGH Episode
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Number of Participants Free From Confirmed HSV-2 RGH Episode242820
SecondaryPart 2: Severity of RGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode Assessed by Herpes Symptoms Checklist (HSC) Total Score

Severity of symptoms was assessed using the Herpes Symptoms Checklist (HSC), a 13-item questionnaire where participants rate symptom severity on a 4-point scale (0 = no symptom; higher scores indicate greater severity). Total scores range from 0 (no symptoms) to 39 (severe symptoms). At the onset of each confirmed HSV-2 recurrent genital herpes episode, participants completed the HSC once daily until all lesions and symptoms resolved. The analysis summarizes HSC total scores across all fully completed questionnaires during confirmed episodes.

Time frame:
From Day 43 [14 days post-Dose 2 (at Day 29)]to Day 394 (the end of the follow-up phase)
Reported as:
Mean · Mean Scores on a scale
Part 2: Severity of RGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode Assessed by Herpes Symptoms Checklist (HSC) Total Score
Mean Scores on a scalePart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Severity of RGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode Assessed by Herpes Symptoms Checklist (HSC) Total Score4.3 ± 3.95.1 ± 5.76.3 ± 6.0
SecondaryPart 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode

Number of days with RGH-associated symptoms during each PCR confirmed HSV-2 RGH episode, as reported by participants. Symptoms were recorded daily from onset of recurrence until resolution of lesions. The analysis summarizes episode-level duration across treatment groups.

Time frame:
From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
Reported as:
Median · Days
Part 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode
DaysPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH Episode6.0 (1 to 16)5.0 (1 to 13)5.0 (2 to 16)
SecondaryPart 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-Year

Lesion rate was calculated as the number of days with confirmed HSV-2 genital herpes lesions (swelling, blisters, sores, or crusts) divided by the total number of person-year, assessed starting 14 days after Dose 2 until the end of the RGH event reporting period.

Time frame:
From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
Reported as:
Number · Lesion days per person-years
Part 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-Year
Lesion days per person-yearsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-Year11.76 (10.97 to 12.59)9.27 (8.58 to 10.02)9.53 (8.82 to 10.28)
SecondaryPart 2: HSV-2 Shedding Rate Reduction

HSV-2 shedding rate was assessed at the overall treatment-group level and was calculated as the total number of HSV-2-positive evaluable anogenital swabs divided by the total number of evaluable anogenital swabs collected during the applicable swabbing period. A Poisson regression model was used to estimate the shedding rate ratio for the 6-week post-Dose 2 swabbing period (Days 43 to 71) relative to baseline (Days -28 to -1). Shedding rate reduction was calculated as 1 minus the model-estimated shedding rate ratio and reported as a decimal with the corresponding 90% confidence interval. Positive values indicate a reduction, and negative values indicate an increase relative to baseline. The outcome was reported using Measure Type "Number" because the result was a model-estimated treatment-group-level reduction rate.

Time frame:
At 6 weeks post-Dose 2 (Day 43 to Day 71) compared to baseline (Day -28 to Day -1)
Reported as:
Number · Ratio
Part 2: HSV-2 Shedding Rate Reduction
RatioPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Part 2: HSV-2 Shedding Rate Reduction-0.33 (-0.92 to 0.08)0.13 (-0.11 to 0.32)0.14 (-0.18 to 0.38)
SecondaryPart 2: Number of HSV-2 DNA Shedding Episodes

An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

Time frame:
From start of the baseline (Day -28) up to Day -1
Reported as:
Number · Episodes
Part 2: Number of HSV-2 DNA Shedding Episodes
EpisodesPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Asymptomatic - Number of shedding episodes406650
Symptomatic - Number of shedding episodes253523
SecondaryPart 2: Number of HSV-2 DNA Shedding Episodes

An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

Time frame:
Day 43 to Day 70
Reported as:
Number · Episodes
Part 2: Number of HSV-2 DNA Shedding Episodes
EpisodesPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Asymptomatic - Number of shedding episodes495156
Symptomatic - Number of shedding episodes202828
SecondaryPart 2: Duration of HSV-2 DNA Shedding Episodes

Duration was defined as the number of consecutive days within an HSV-2 DNA shedding episode. An HSV-2 DNA shedding episode is defined as a sequence of days in which a participant has positive swabs during a swabbing period. A new episode starts when viral load is detected following at least 2 swabs in which viral load is not detected or is missing.

Time frame:
From start of the baseline (Day -28) up to Day -1
Reported as:
Median · Days
Part 2: Duration of HSV-2 DNA Shedding Episodes
DaysPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Asymptomatic - Duration of shedding episodes (days)1.3 (0.5 to 16.5)1.0 (0.5 to 21.5)1.5 (0.5 to 19.0)
Symptomatic - Duration of shedding episodes (days)4.5 (0.5 to 14.5)4.0 (0.5 to 13.0)5.0 (1.0 to 27.5)
SecondaryPart 2: Duration of HSV-2 DNA Shedding Episodes
Time frame:
Day 43 to Day 70
Reported as:
Median · Days
Part 2: Duration of HSV-2 DNA Shedding Episodes
DaysPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Asymptomatic - Duration of shedding episodes (days)1.0 (0.5 to 16.5)1.5 (0.5 to 8.0)1.3 (0.5 to 12.5)
Symptomatic - Duration of shedding episodes (days)4.0 (0.5 to 10.5)3.5 (0.5 to 10.0)2.3 (0.5 to 12.5)
SecondaryPart 1: Anti-Glycoprotein E/I (gE-gI) Antibody Geometric Mean Concentration (GMC)

GMC of total IgG antibodies binding to the HSV-2 gE-gI heterodimer, using enzyme-linked immunosorbent assay (ELISA).

Time frame:
At Day 1, Day 29, Day 64, Day 209 and Day 394
Reported as:
Geometric mean · ELISA units per milliliter (EU/mL)
Part 1: Anti-Glycoprotein E/I (gE-gI) Antibody Geometric Mean Concentration (GMC)
ELISA units per milliliter (EU/mL)Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Day 12.3 (1.0 to 5.3)3.6 (1.5 to 8.7)2.6 (1.2 to 5.5)3.1 (1.3 to 7.1)6.3 (2.4 to 16.3)3.5 (1.4 to 9.1)4.5 (1.8 to 11.5)4.8 (2.0 to 11.6)4.3 (1.7 to 10.6)3.1 (1.2 to 8.0)
Day 293.3 (1.0 to 10.6)7.4 (2.1 to 25.7)13.6 (3.1 to 58.9)203.5 (131.5 to 314.9)319.2 (210.2 to 484.5)323.6 (219.0 to 478.2)249.8 (146.3 to 426.7)261.0 (150.4 to 452.8)312.2 (200.9 to 485.1)2.8 (1.0 to 7.3)
Day 6412.0 (4.0 to 35.6)28.9 (9.9 to 84.4)66.1 (23.1 to 189.3)715.1 (545.0 to 938.3)845.3 (647.9 to 1102.9)940.8 (718.8 to 1231.3)651.3 (456.7 to 928.7)742.7 (519.5 to 1061.8)756.7 (553.2 to 1035.3)2.8 (1.0 to 7.6)
Day 2095.7 (2.0 to 16.0)12.3 (4.0 to 37.7)22.7 (6.9 to 74.0)312.2 (214.0 to 455.6)294.0 (194.3 to 444.7)479.7 (305.8 to 752.5)274.7 (156.3 to 482.8)364.8 (220.6 to 603.3)351.4 (216.1 to 571.4)2.9 (1.1 to 7.7)
Day 3944.8 (1.6 to 13.9)10.1 (3.2 to 31.4)11.3 (3.0 to 43.3)176.7 (118.2 to 264.2)171.6 (118.0 to 249.4)163.9 (101.5 to 264.9)174.7 (101.4 to 301.1)170.0 (106.7 to 271.0)181.7 (111.2 to 296.8)2.6 (0.9 to 7.2)
SecondaryPart 2: Anti-gE-gI Antibody GMC

GMC of total IgG antibodies binding to the HSV-2 gE-gI heterodimer, using ELISA.

Time frame:
At Day 1, Day 29 and Day 57
Reported as:
Geometric mean · EU/mL
Part 2: Anti-gE-gI Antibody GMC
EU/mLPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Day 197.1 (81.8 to 115.2)98.5 (83.2 to 116.6)83.7 (70.6 to 99.4)
Day 291354.2 (1181.7 to 1551.8)1213.4 (1038.7 to 1417.5)88.0 (73.4 to 105.5)
Day 571780.0 (1623.4 to 1951.8)1675.0 (1520.6 to 1845.0)104.3 (86.2 to 126.2)
SecondaryPart 1: Number of Participants With HSV-2 gE-gI Binding Immunoglobulin G (IgG) Concentrations >= 0.99 EU/mL (Seropositive Rate), Assessed by ELISA

A seropositive participant is a participant whose antibody concentration is greater than or equal to the assay cut-off value (≥ 0.99 EU/mL).

Time frame:
At Day 1, Day 29, Day 64, Day 209 and Day 394
Reported as:
Count of participants · Participants
Part 1: Number of Participants With HSV-2 gE-gI Binding Immunoglobulin G (IgG) Concentrations >= 0.99 EU/mL (Seropositive Rate), Assessed by ELISA
ParticipantsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Day 111121212141113141310
Day 29912132523232221239
Day 641920212522232221239
Day 20915171724222321201910
Day 3941315132321182119218
SecondaryPart 2: Number of Participants With HSV-2 gE-gI Binding IgG Concentrations >= 1.38 EU/mL (Seropositive Rate), Assessed by ELISA

A seropositive participant is defined as one whose HSV-2 gE-gI IgG concentration is ≥ the assay cut-off (0.99 EU/mL), as measured by ELISA.

Time frame:
At Day 1, Day 29 and Day 57
Reported as:
Count of participants · Participants
Part 2: Number of Participants With HSV-2 gE-gI Binding IgG Concentrations >= 1.38 EU/mL (Seropositive Rate), Assessed by ELISA
ParticipantsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Day 1848384
Day 29777774
Day 57686758
SecondaryPart 1: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells

Geometric Mean Frequency of Polypositive gE-gI-Specific CD4⁺ T Cells Expressing \>= 2 Activation Markers (Interferon \[IFN\]-gamma, Tumour necrosis factor \[TNF\]-alpha, Interleukin \[IL\]-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

Time frame:
At Day 1, Day 29, Day 64, Day 209 and Day 394
Reported as:
Geometric mean · HSVTI-specific CD4+ T cells/10^6 cells
Part 1: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells
HSVTI-specific CD4+ T cells/10^6 cellsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Day 126.8 ± 0.942.0 ± 0.963.4 ± 0.830.6 ± 0.949.8 ± 1.017.7 ± 0.945.5 ± 0.835.0 ± 1.021.8 ± 0.830.1 ± 0.8
Day 2955.5 ± 0.940.4 ± 1.063.6 ± 1.0407.1 ± 0.3220.8 ± 0.9311.6 ± 0.7346.4 ± 0.4182.9 ± 0.7198.0 ± 0.8198.0 ± 0.8
Day 6453.4 ± 1.031.0 ± 1.2165.1 ± 1.14015.0 ± 0.22604.3 ± 0.32921.6 ± 0.22267.7 ± 0.31777.0 ± 0.3968.6 ± 0.755.9 ± 0.9
Day 20939.4 ± 1.081.5 ± 0.9122.2 ± 0.92006.7 ± 0.31261.3 ± 0.41548.2 ± 0.31212.2 ± 0.61035.8 ± 0.3693.0 ± 0.448.5 ± 0.9
Day 39458.1 ± 1.052.5 ± 1.071.9 ± 1.01444.6 ± 0.51192.5 ± 0.31267.7 ± 0.2959.6 ± 0.4680.7 ± 0.6440.3 ± 0.834.7 ± 1.0
SecondaryPart 2: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells

Geometric Mean Frequency of Polypositive gE-gI-Specific CD4⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

Time frame:
At Day 1, Day 29, and Day 57
Reported as:
Geometric mean · HSVTI-specific CD4+ T cells/10^6 cells
Part 2: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells
HSVTI-specific CD4+ T cells/10^6 cellsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Day 129.5 ± 1.0111.9 ± 0.772.6 ± 0.8
Day 291235.3 ± 0.41537.1 ± 0.480.2 ± 0.9
Day 573566.5 ± 0.23515.0 ± 0.359.7 ± 0.9
SecondaryPart 1: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency

Geometric Mean Frequency of Polypositive gE-gI-Specific CD8⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

Time frame:
At Day 1, Day 29, Day 64, Day 209 and Day 394
Reported as:
Geometric mean · HSVTI-specific CD8+ T cells/10^6 cells
Part 1: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency
HSVTI-specific CD8+ T cells/10^6 cellsPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: Placebo
Day 125.4 ± 0.817.2 ± 0.823.2 ± 0.830.8 ± 0.827.3 ± 0.915.9 ± 0.97.7 ± 0.720.2 ± 0.98.8 ± 0.815.2 ± 0.9
Day 2911.2 ± 0.910.2 ± 0.812.3 ± 0.928.2 ± 0.822.5 ± 1.013.5 ± 0.99.3 ± 0.822.8 ± 0.914.7 ± 0.86.3 ± 0.8
Day 6412.6 ± 0.98.9 ± 0.911.1 ± 0.835.8 ± 0.835.1 ± 0.843.3 ± 0.732.4 ± 0.820.6 ± 1.013.9 ± 0.913.4 ± 0.8
Day 2095.9 ± 0.711.6 ± 1.020.3 ± 0.936.8 ± 0.719.6 ± 1.017.6 ± 1.012.7 ± 0.826.1 ± 0.98.0 ± 0.823.4 ± 0.9
Day 39416.9 ± 0.923.5 ± 0.89.6 ± 0.919.6 ± 0.929.0 ± 0.819.8 ± 0.924.5 ± 0.815.1 ± 0.814.5 ± 0.810.4 ± 0.8
SecondaryPart 2: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency

Geometric Mean Frequency of Polypositive gE-gI-Specific CD8⁺ T Cells Expressing \>= 2 Activation Markers (IFN-gamma, TNF-alpha, IL-2, IL-13, IL-17, 4-1BB and CD40L), Including \>=1 Cytokine, Assessed by CFC (cell flow cytometry).

Time frame:
At Day 1, Day 29, and Day 57
Reported as:
Geometric mean · HSVTI-specific CD8+ T cells/10^6 cells
Part 2: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells Frequency
HSVTI-specific CD8+ T cells/10^6 cellsPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: Placebo
Day 127.0 ± 0.934.7 ± 0.921.1 ± 0.9
Day 2943.4 ± 1.071.9 ± 1.021.6 ± 0.9
Day 57153.6 ± 0.880.6 ± 0.921.7 ± 0.9

Adverse events

Collected over Solicited AEs: from Day 1 to Day 7 post Dose 1 (at Day 1) and from Day 29 to Day 35 post Dose 2 (at Day 29); Unsolicited AEs: from Day 1 to Day 28 post Dose 1 (at Day 1) and from Day 29 to Day 56 post dose 2 (at Day 29); SAEs, MAEs, pIMDs: from Day 1 to Day 394. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI)_Low Dose0/25 (0%)0/25 (0%)19/25 (76%)
Part 1: Non-adjuvanted HSVTI_Medium Dose0/24 (0%)0/24 (0%)14/24 (58.3%)
Part 1: Non-adjuvanted HSVTI_High Dose0/24 (0%)0/24 (0%)13/24 (54.2%)
Part 1: HSVTI_Low Dose With Adjuvant 10/25 (0%)0/25 (0%)24/25 (96%)
Part 1: HSVTI_Medium Dose With Adjuvant 10/24 (0%)1/24 (4.2%)24/24 (100%)
Part 1: HSVTI_High Dose With Adjuvant 10/24 (0%)0/24 (0%)24/24 (100%)
Part 1: HSVTI_Low Dose With Adjuvant 20/25 (0%)0/25 (0%)23/25 (92%)
Part 1: HSVTI_Medium Dose With Adjuvant 20/25 (0%)3/25 (12%)25/25 (100%)
Part 1: HSVTI_High Dose With Adjuvant 20/25 (0%)1/25 (4%)23/25 (92%)
Part 1: Placebo0/20 (0%)0/20 (0%)15/20 (75%)
Part 2: HSVTI_Medium Dose With Adjuvant 10/86 (0%)1/86 (1.2%)86/86 (100%)
Part 2: HSVTI_Medium Dose With Adjuvant 20/86 (0%)0/86 (0%)85/86 (98.8%)
Part 2: Placebo0/90 (0%)2/90 (2.2%)69/90 (76.7%)
Most frequent serious events
Most frequent serious events
EventPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI)_Low DosePart 1: Non-adjuvanted HSVTI_Medium DosePart 1: Non-adjuvanted HSVTI_High DosePart 1: HSVTI_Low Dose With Adjuvant 1Part 1: HSVTI_Medium Dose With Adjuvant 1Part 1: HSVTI_High Dose With Adjuvant 1Part 1: HSVTI_Low Dose With Adjuvant 2Part 1: HSVTI_Medium Dose With Adjuvant 2Part 1: HSVTI_High Dose With Adjuvant 2Part 1: PlaceboPart 2: HSVTI_Medium Dose With Adjuvant 1Part 2: HSVTI_Medium Dose With Adjuvant 2Part 2: Placebo
PresyncopeNervous system disorders0/250/240/240/251/240/240/250/250/250/200/860/860/90
Bacterial pyelonephritisInfections and infestations0/250/240/240/250/240/240/251/250/250/200/860/860/90
Ligament ruptureInjury, poisoning and procedural complications0/250/240/240/250/240/240/250/251/250/200/860/860/90
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/250/240/240/250/240/240/251/250/250/200/860/860/90
Vestibular migraineNervous system disorders0/250/240/240/250/240/240/251/250/250/200/860/860/90
Multiple fracturesInjury, poisoning and procedural complications0/250/240/240/250/240/240/250/250/250/201/860/860/90
Traumatic haematomaInjury, poisoning and procedural complications0/250/240/240/250/240/240/250/250/250/201/860/860/90
Myocardial infarctionCardiac disorders0/250/240/240/250/240/240/250/250/250/200/860/861/90
Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/250/240/240/250/240/240/250/250/250/200/860/861/90
Most frequent other events
Showing 10 of 183
Most frequent other events
EventPart 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI)_Low DosePart 1: Non-adjuvanted HSVTI_Medium DosePart 1: Non-adjuvanted HSVTI_High DosePart 1: HSVTI_Low Dose With Adjuvant 1Part 1: HSVTI_Medium Dose With Adjuvant 1Part 1: HSVTI_High Dose With Adjuvant 1Part 1: HSVTI_Low Dose With Adjuvant 2Part 1: HSVTI_Medium Dose With Adjuvant 2Part 1: HSVTI_High Dose With Adjuvant 2Part 1: PlaceboPart 2: HSVTI_Medium Dose With Adjuvant 1Part 2: HSVTI_Medium Dose With Adjuvant 2Part 2: Placebo
Administration site painGeneral disorders5/253/243/2424/2523/2424/2421/2523/2522/252/2085/8680/8619/90
FatigueGeneral disorders8/258/244/2416/2519/2416/249/2513/2512/259/2082/8670/8645/90
HeadacheNervous system disorders14/256/247/2419/2513/2420/2415/2514/2515/2510/2071/8667/8638/90
MyalgiaMusculoskeletal and connective tissue disorders3/254/245/2417/2516/2417/2412/2513/2514/255/2070/8663/8624/90
ArthralgiaMusculoskeletal and connective tissue disorders1/252/243/247/257/246/243/252/255/251/2043/8638/8613/90
Administration site erythemaGeneral disorders1/250/241/247/255/2410/241/255/256/250/2021/8621/860/90
PyrexiaGeneral disorders1/250/241/245/258/246/240/254/252/251/2024/8612/862/90
NauseaGastrointestinal disorders0/250/240/242/255/244/240/251/251/251/203/862/862/90
Administration site swellingGeneral disorders1/250/241/242/252/242/242/253/253/250/2015/867/860/90
Injection site haemorrhageGeneral disorders1/250/240/241/251/240/241/254/250/251/200/860/860/90

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: PlaceboPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: PlaceboTotal
Part 126.8 ± 6.027.2 ± 7.728.5 ± 6.427.1 ± 6.729.9 ± 7.029.2 ± 5.927.0 ± 6.327.3 ± 6.328.1 ± 5.329.0 ± 7.1———28.0 ± 6.5
Part 2——————————38.8 ± 9.239.8 ± 9.939.1 ± 9.839.2 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: PlaceboPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: PlaceboTotal
Female17141516202018151513434347296
Male8109944710107434343207
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)Part 1: HSVTI (40 µg gE-gI/AS01B)Part 1: HSVTI (80 µg gE-gI/AS01B)Part 1: HSVTI (160 µg gE-gI/AS01B)Part 1: HSVTI (40 µg gE-gI/AS01E)Part 1: HSVTI (80 µg gE-gI/AS01E)Part 1: HSVTI (160 µg gE-gI/AS01E)Part 1: PlaceboPart 2: HSVTI (80 µg gE-gI/AS01B)Part 2: HSVTI (80 µg gE-gI/AS01E)Part 2: PlaceboTotal
BLACK OR AFRICAN AMERICAN000001100085722
AMERICAN INDIAN OR ALASKA NATIVE00000000001001
ASIAN - CENTRAL / SOUTH ASIAN HERITAGE00000000000101
ASIAN - EAST ASIAN HERITAGE00000000001113
ASIAN - SOUTH EAST ASIAN HERITAGE10000000002036
WHITE - ARABIC / NORTH AFRICAN HERITAGE00001000001215
WHITE - CAUCASIAN / EUROPEAN HERITAGE24242425232324252520697369448
OTHER000000000044917
08

Study locations

29 sites
  • GSK Investigational Site
    Phoenix, Arizona 85015, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Kansas City, Missouri 64114, United States
  • GSK Investigational Site
    Rochester, New York 14609, United States
  • GSK Investigational Site
    Richmond, Virginia 23219, United States
  • GSK Investigational Site
    Seattle, Washington 98105, United States
  • GSK Investigational Site
    Darlinghurst, New South Wales 2010, Australia
  • GSK Investigational Site
    Sydney, New South Wales 2010, Australia
  • GSK Investigational Site
    Antwerp, 2000, Belgium
  • GSK Investigational Site
    Brussels, 1000, Belgium
  • GSK Investigational Site
    Ghent, 9000, Belgium
  • GSK Investigational Site
    Montreal, Quebec H2L 4E9, Canada
  • GSK Investigational Site
    Tartu, 50106, Estonia
  • GSK Investigational Site
    Berlin, 10117, Germany
  • GSK Investigational Site
    Berlin, 10439, Germany
  • GSK Investigational Site
    Bochum, 44787, Germany
  • GSK Investigational Site
    Cologne, 50674, Germany
  • GSK Investigational Site
    Frankfurt, 60596, Germany
  • GSK Investigational Site
    Hamburg, 20146, Germany
  • GSK Investigational Site
    Barcelona, 08001, Spain
  • GSK Investigational Site
    Barcelona, 08015, Spain
  • GSK Investigational Site
    Madrid, 28010, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
  • GSK Investigational Site
    Madrid, 28222, Spain
  • GSK Investigational Site
    Marbella, 29600, Spain
  • GSK Investigational Site
    Brighton, BN2 1ES, United Kingdom
  • GSK Investigational Site
    Liverpool, L7 8XP, United Kingdom
  • GSK Investigational Site
    London, WC1E 6JB, United Kingdom
  • GSK Investigational Site
    Southampton, SO14 0YG, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · www.gsk-studyregister.com

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Nov 9, 2026
Sites
1 site removed
Show 1 removed
  • GSK Investigational Site · Edegem, Belgium
Nov 9, 2026
Enrollment
505→504
Nov 9, 2026
Eligibility
1 inclusion criterion added; 2 exclusion criteria edited, 1 added
What changed in the criteria
Inclusion criteria
  • AddedOnly for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period. This criterion can only be checked at Visit 1 (Day 1).
Exclusion criteria
  • EditedBody mass index =< 18 kg/m\^2 or >= 35 kg/m\^2.
  • EditedOnly for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
  • AddedOnly for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
Nov 9, 2026
Interventions
Added Biological: 40 µg gE-gI·Biological: 80 µg gE-gI·Biological: 160 µg gE-gI·Biological: 40 µg gE-gI/AS01B·Biological: 80 µg gE-gI/AS01B·and 4 more
All 9

Biological: 40 µg gE-gI · Biological: 80 µg gE-gI · Biological: 160 µg gE-gI · Biological: 40 µg gE-gI/AS01B · Biological: 80 µg gE-gI/AS01B · Biological: 60 µg gE-gI/AS01B · Biological: 40 µg gE-gI/AS01E · Biological: 80 µg gE-gI/AS01E · Biological: 160 µg gE-gI/AS01E

; removed Biological: Non-adjuvanted HSV formulation 1·Biological: Non-adjuvanted HSV formulation 2·Biological: Non-adjuvanted HSV formulation 3·Biological: HSV formulation 1 with adjuvant 1·Biological: HSV formulation 2 with adjuvant 1·and 6 more
All 11

Biological: Non-adjuvanted HSV formulation 1 · Biological: Non-adjuvanted HSV formulation 2 · Biological: Non-adjuvanted HSV formulation 3 · Biological: HSV formulation 1 with adjuvant 1 · Biological: HSV formulation 2 with adjuvant 1 · Biological: HSV formulation 3 with adjuvant 1 · Biological: HSV formulation 1 with adjuvant 2 · Biological: HSV formulation 2 with adjuvant 2 · Biological: HSV formulation 3 with adjuvant 2 · Biological: HSVTI_F1 · Biological: HSVTI_F2

. Arms added: Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)·Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)·Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)·Part 1: HSVTI (40 µg gE-gI/AS01B)·Part 1: HSVTI (80 µg gE-gI/AS01B)·and 8 more
All 13

Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI) · Part 1: Non-adjuvanted HSVTI (80 µg gE-gI) · Part 1: Non-adjuvanted HSVTI (160 µg gE-gI) · Part 1: HSVTI (40 µg gE-gI/AS01B) · Part 1: HSVTI (80 µg gE-gI/AS01B) · Part 1: HSVTI (160 µg gE-gI/AS01B) · Part 1: HSVTI (40 µg gE-gI/AS01E) · Part 1: HSVTI (80 µg gE-gI/AS01E) · Part 1: HSVTI (160 µg gE-gI/AS01E) · Part 1: Placebo · Part 2: HSVTI (80 µg gE-gI/AS01B) · Part 2: HSVTI (80 µg gE-gI/AS01E) · Part 2: Placebo

; arms removed: Non-adjuvanted HSV formulation 1 - Part I Group·Non-adjuvanted HSV formulation 2 - Part I Group·Non-adjuvanted HSV formulation 3 - Part I Group·HSV formulation 1 with adjuvant 1 - Part I Group·HSV formulation 2 with adjuvant 1 - Part I Group·and 8 more
All 13

Non-adjuvanted HSV formulation 1 - Part I Group · Non-adjuvanted HSV formulation 2 - Part I Group · Non-adjuvanted HSV formulation 3 - Part I Group · HSV formulation 1 with adjuvant 1 - Part I Group · HSV formulation 2 with adjuvant 1 - Part I Group · HSV formulation 3 with adjuvant 1 - Part I Group · HSV formulation 1 with adjuvant 2 - Part I Group · HSV formulation 2 with adjuvant 2 - Part I Group · HSV formulation 3 with adjuvant 2 - Part I Group · Placebo - Part I Group · HSVTI formulation (F) 1 - Part II Group · HSVTI_F2 - Part II Group · Placebo - Part II Group

Nov 9, 2026
Primary outcomes
14 edited, 7 added, 6 removed
What changed in the outcomes
  • EditedPercentagePart 1: Number of participants reporting each solicited administration site eventParticipants With Solicited Administration Site EventsTime frame: Within 7 days after the first study intervention dose (administered at Day 1) → Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • EditedPercentagePart 2: Number of participants reporting each solicited administration site eventParticipants With Solicited Administration Site EventsTime frame: Within 7 days after the second study intervention dose (administered at Day 29) → Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • EditedPercentagePart 1: Number of participants reporting unsolicited adverse eventsParticipants With Unsolicited Adverse Events (AEs)Time frame: Within 28 days after the first study intervention dose (administered at Day 1) → During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • EditedPercentagePart 1: Number of participants reporting medically attended eventsParticipants With Medically Attended AEs (MAEs)Time frame: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394) → From Day 1 to Day 394
  • EditedPercentagePart 1: Number of participants reporting any serious adverse eventsParticipants With Serious AEs (SAEs)Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) → From Day 1 to Day 394
  • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 8 in Part I of the studyTime frame: At Day 8
  • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 29 in Part I of the studyTime frame: At Day 29
  • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 36 in Part I of the studyTime frame: At Day 36
  • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 64 in Part I of the studyTime frame: At Day 64
  • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 8 in Part II of the studyTime frame: At Day 8
  • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 29 in part II of the studyTime frame: At Day 29
  • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 36 in Part II of the studyTime frame: At Day 36
  • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 57 in Part II of the studyTime frame: At Day 57
  • EditedPart 2: Time- to-first confirmed First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH episode in Part II of the study) EpisodeTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
  • AddedPart 1: Number of Participants With Solicited Systemic EventsTime frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • AddedPart 2: Number of Participants With Solicited Systemic EventsTime frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • AddedPart 2: Number of Participants With Unsolicited AEsTime frame: During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
  • AddedPart 2: Number of Participants With MAEsTime frame: From Day 1 to Day 394
  • AddedPart 2: Number of Participants With SAEsTime frame: From Day 1 to Day 394
  • AddedPart 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)Time frame: From Day 1 to Day 394
  • AddedPart 2: Number of Participants With pIMDsTime frame: From Day 1 to Day 394
  • RemovedPercentage of participants reporting each solicited systemic eventTime frame: Within 7 days after the first study intervention dose (administered at Day 1)
  • RemovedPercentage of participants reporting each solicited systemic eventTime frame: Within 7 days after the second study intervention dose (administered at Day 29)
  • RemovedPercentage of participants reporting unsolicited adverse events (AEs)Time frame: Within 28 days after the second study intervention dose (administered at Day 29)
  • RemovedPercentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
  • RemovedPercentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the studyTime frame: At pre-study intervention administration (Day 1)
  • RemovedPercentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the studyTime frame: At pre-study intervention administration (Day 1)
Nov 9, 2026
Documents
Nov 9, 2026
Secondary outcomes
8 edited, 10 added, 12 removed
What changed in the outcomes
  • EditedNumberPart 2: Incidence Rate of confirmedPCR- Confirmed HSV-2 RGH episodes in Part II of the studyEpisodesTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
  • EditedPercentagePart 2: Number of participants free from confirmedParticipants Free From Confirmed HSV-2 RGH episode in Part II of the studyEpisodeTime frame: At 6 months after the last study intervention administration (Day 29) → From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 209 (6 months post-Dose 2)
  • EditedNumberPart 2: Severity of days with RGH-associated symptoms during each confirmedRGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH episode in Part II of the studyEpisode Assessed by Herpes Symptoms Checklist (HSC) Total ScoreTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post-Dose 2 (at Day 29)]to Day 394 (the end of the follow-up phase)
  • EditedPart 2: Number of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day -28 to Day -1 → From start of the baseline (Day -28) up to Day -1
  • EditedPart 2: Number of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day 43 to Day 70
  • EditedNumberPart 2: Duration of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day 181 to Day 208 → From start of the baseline (Day -28) up to Day -1
  • EditedPart 2: Duration of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day -28 to Day -1 → Day 43 to Day 70
  • EditedPart 1: Geometric meanMean of HSVTIPolypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 → At Day 1, Day 29, Day 64, Day 209 and Day 394
  • AddedPart 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH EpisodeTime frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
  • AddedPart 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-YearTime frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
  • AddedPart 2: HSV-2 Shedding Rate ReductionTime frame: At 6 weeks post-Dose 2 (Day 43 to Day 71) compared to baseline (Day -28 to Day -1)
  • AddedPart 1: Anti-Glycoprotein E/I (gE-gI) Antibody Geometric Mean Concentration (GMC)Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
  • AddedPart 2: Anti-gE-gI Antibody GMCTime frame: At Day 1, Day 29 and Day 57
  • AddedPart 1: Number of Participants With HSV-2 gE-gI Binding Immunoglobulin G (IgG) Concentrations >= 0.99 EU/mL (Seropositive Rate), Assessed by ELISATime frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
  • AddedPart 2: Number of Participants With HSV-2 gE-gI Binding IgG Concentrations >= 1.38 EU/mL (Seropositive Rate), Assessed by ELISATime frame: At Day 1, Day 29 and Day 57
  • AddedPart 2: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cellsTime frame: At Day 1, Day 29, and Day 57
  • AddedPart 1: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells FrequencyTime frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
  • AddedPart 2: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells FrequencyTime frame: At Day 1, Day 29, and Day 57
  • RemovedHerpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the studyTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
  • RemovedNumber of days with confirmed HSV-2 genital herpes lesions in Part II of the studyTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
  • RemovedHSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the studyTime frame: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
  • RemovedDuration of HSV-2 DNA shedding episodes in Part II of the studyTime frame: Day 43 to Day 70
  • RemovedDuration of HSV-2 DNA shedding episodes in Part II of the studyTime frame: Day 181 to Day 208
  • RemovedAnti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
  • RemovedAnti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
  • RemovedPercentage of seropositive participants for anti-HSVTI antibodies in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
  • RemovedPercentage of seropositive participants for anti-HSVTI antibodies in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
  • RemovedGeometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
  • RemovedGeometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
  • RemovedGeometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Results posted
    Documents Study protocol ↗ posted · Statistical analysis plan ↗ posted
    1 site removed
    Show 1 removed
    • GSK Investigational Site · Edegem, Belgium
    Enrollment 505→504
    Eligibility 1 inclusion criterion added; 2 exclusion criteria edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • AddedOnly for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period. This criterion can only be checked at Visit 1 (Day 1).
    Exclusion criteria
    • EditedBody mass index =< 18 kg/m\^2 or >= 35 kg/m\^2.
    • EditedOnly for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
    • AddedOnly for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
    Primary outcomes 14 edited, 7 added, 6 removed
    What changed in the outcomes
    • EditedPercentagePart 1: Number of participants reporting each solicited administration site eventParticipants With Solicited Administration Site EventsTime frame: Within 7 days after the first study intervention dose (administered at Day 1) → Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • EditedPercentagePart 2: Number of participants reporting each solicited administration site eventParticipants With Solicited Administration Site EventsTime frame: Within 7 days after the second study intervention dose (administered at Day 29) → Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • EditedPercentagePart 1: Number of participants reporting unsolicited adverse eventsParticipants With Unsolicited Adverse Events (AEs)Time frame: Within 28 days after the first study intervention dose (administered at Day 1) → During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • EditedPercentagePart 1: Number of participants reporting medically attended eventsParticipants With Medically Attended AEs (MAEs)Time frame: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394) → From Day 1 to Day 394
    • EditedPercentagePart 1: Number of participants reporting any serious adverse eventsParticipants With Serious AEs (SAEs)Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) → From Day 1 to Day 394
    • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 8 in Part I of the studyTime frame: At Day 8
    • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 29 in Part I of the studyTime frame: At Day 29
    • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 36 in Part I of the studyTime frame: At Day 36
    • EditedPercentagePart 1: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 64 in Part I of the studyTime frame: At Day 64
    • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 8 in Part II of the studyTime frame: At Day 8
    • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 29 in part II of the studyTime frame: At Day 29
    • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 36 in Part II of the studyTime frame: At Day 36
    • EditedPercentagePart 2: Number of participants reporting any haematologicalParticipants With Haematological and biochemical laboratory abnormalitiesBiochemical Laboratory Shifts at Day 57 in Part II of the studyTime frame: At Day 57
    • EditedPart 2: Time- to-first confirmed First PCR Confirmed HSV-2 Recurrent Genital Herpes (RGH episode in Part II of the study) EpisodeTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
    • AddedPart 1: Number of Participants With Solicited Systemic EventsTime frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • AddedPart 2: Number of Participants With Solicited Systemic EventsTime frame: Within 7 days post-dose (day of administration and 6 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • AddedPart 2: Number of Participants With Unsolicited AEsTime frame: During 28 days after each dose (day of administration and 27 subsequent days after each dose; Dose 1 on Day 1 and Dose 2 on Day 29)
    • AddedPart 2: Number of Participants With MAEsTime frame: From Day 1 to Day 394
    • AddedPart 2: Number of Participants With SAEsTime frame: From Day 1 to Day 394
    • AddedPart 1: Number of Participants With Potential Immune-mediated Diseases (pIMDs)Time frame: From Day 1 to Day 394
    • AddedPart 2: Number of Participants With pIMDsTime frame: From Day 1 to Day 394
    • RemovedPercentage of participants reporting each solicited systemic eventTime frame: Within 7 days after the first study intervention dose (administered at Day 1)
    • RemovedPercentage of participants reporting each solicited systemic eventTime frame: Within 7 days after the second study intervention dose (administered at Day 29)
    • RemovedPercentage of participants reporting unsolicited adverse events (AEs)Time frame: Within 28 days after the second study intervention dose (administered at Day 29)
    • RemovedPercentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
    • RemovedPercentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the studyTime frame: At pre-study intervention administration (Day 1)
    • RemovedPercentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the studyTime frame: At pre-study intervention administration (Day 1)
    Secondary outcomes 8 edited, 10 added, 12 removed
    What changed in the outcomes
    • EditedNumberPart 2: Incidence Rate of confirmedPCR- Confirmed HSV-2 RGH episodes in Part II of the studyEpisodesTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
    • EditedPercentagePart 2: Number of participants free from confirmedParticipants Free From Confirmed HSV-2 RGH episode in Part II of the studyEpisodeTime frame: At 6 months after the last study intervention administration (Day 29) → From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 209 (6 months post-Dose 2)
    • EditedNumberPart 2: Severity of days with RGH-associated symptoms during each confirmedRGH Episode-Associated Symptoms During Each PCR Confirmed HSV-2 RGH episode in Part II of the studyEpisode Assessed by Herpes Symptoms Checklist (HSC) Total ScoreTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period → From Day 43 [14 days post-Dose 2 (at Day 29)]to Day 394 (the end of the follow-up phase)
    • EditedPart 2: Number of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day -28 to Day -1 → From start of the baseline (Day -28) up to Day -1
    • EditedPart 2: Number of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day 43 to Day 70
    • EditedNumberPart 2: Duration of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day 181 to Day 208 → From start of the baseline (Day -28) up to Day -1
    • EditedPart 2: Duration of HSV-2 DNA shedding episodes in Part II of the studyShedding EpisodesTime frame: Day -28 to Day -1 → Day 43 to Day 70
    • EditedPart 1: Geometric meanMean of HSVTIPolypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 → At Day 1, Day 29, Day 64, Day 209 and Day 394
    • AddedPart 2: Duration of RGH-associated Symptoms During Each PCR Confirmed HSV-2 RGH EpisodeTime frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
    • AddedPart 2: Lesion Rate of Confirmed HSV-2 Genital Herpes Episodes Per Person-YearTime frame: From Day 43 [14 days post-Dose 2 (at Day 29)] to Day 394 (the end of the follow-up phase)
    • AddedPart 2: HSV-2 Shedding Rate ReductionTime frame: At 6 weeks post-Dose 2 (Day 43 to Day 71) compared to baseline (Day -28 to Day -1)
    • AddedPart 1: Anti-Glycoprotein E/I (gE-gI) Antibody Geometric Mean Concentration (GMC)Time frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
    • AddedPart 2: Anti-gE-gI Antibody GMCTime frame: At Day 1, Day 29 and Day 57
    • AddedPart 1: Number of Participants With HSV-2 gE-gI Binding Immunoglobulin G (IgG) Concentrations >= 0.99 EU/mL (Seropositive Rate), Assessed by ELISATime frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
    • AddedPart 2: Number of Participants With HSV-2 gE-gI Binding IgG Concentrations >= 1.38 EU/mL (Seropositive Rate), Assessed by ELISATime frame: At Day 1, Day 29 and Day 57
    • AddedPart 2: Geometric Mean of Polypositive gE-gI-specific Cluster of Differentiation (CD)4+ T-cellsTime frame: At Day 1, Day 29, and Day 57
    • AddedPart 1: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells FrequencyTime frame: At Day 1, Day 29, Day 64, Day 209 and Day 394
    • AddedPart 2: Geometric Mean of Polypositive gE-gI-specific CD8+ T-cells FrequencyTime frame: At Day 1, Day 29, and Day 57
    • RemovedHerpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the studyTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
    • RemovedNumber of days with confirmed HSV-2 genital herpes lesions in Part II of the studyTime frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
    • RemovedHSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the studyTime frame: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
    • RemovedDuration of HSV-2 DNA shedding episodes in Part II of the studyTime frame: Day 43 to Day 70
    • RemovedDuration of HSV-2 DNA shedding episodes in Part II of the studyTime frame: Day 181 to Day 208
    • RemovedAnti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
    • RemovedAnti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
    • RemovedPercentage of seropositive participants for anti-HSVTI antibodies in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
    • RemovedPercentage of seropositive participants for anti-HSVTI antibodies in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
    • RemovedGeometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
    • RemovedGeometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the studyTime frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
    • RemovedGeometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the studyTime frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
    Interventions Added Biological: 40 µg gE-gI·Biological: 80 µg gE-gI·Biological: 160 µg gE-gI·Biological: 40 µg gE-gI/AS01B·Biological: 80 µg gE-gI/AS01B·and 4 more
    All 9

    Biological: 40 µg gE-gI · Biological: 80 µg gE-gI · Biological: 160 µg gE-gI · Biological: 40 µg gE-gI/AS01B · Biological: 80 µg gE-gI/AS01B · Biological: 60 µg gE-gI/AS01B · Biological: 40 µg gE-gI/AS01E · Biological: 80 µg gE-gI/AS01E · Biological: 160 µg gE-gI/AS01E

    ; removed Biological: Non-adjuvanted HSV formulation 1·Biological: Non-adjuvanted HSV formulation 2·Biological: Non-adjuvanted HSV formulation 3·Biological: HSV formulation 1 with adjuvant 1·Biological: HSV formulation 2 with adjuvant 1·and 6 more
    All 11

    Biological: Non-adjuvanted HSV formulation 1 · Biological: Non-adjuvanted HSV formulation 2 · Biological: Non-adjuvanted HSV formulation 3 · Biological: HSV formulation 1 with adjuvant 1 · Biological: HSV formulation 2 with adjuvant 1 · Biological: HSV formulation 3 with adjuvant 1 · Biological: HSV formulation 1 with adjuvant 2 · Biological: HSV formulation 2 with adjuvant 2 · Biological: HSV formulation 3 with adjuvant 2 · Biological: HSVTI_F1 · Biological: HSVTI_F2

    . Arms added: Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI)·Part 1: Non-adjuvanted HSVTI (80 µg gE-gI)·Part 1: Non-adjuvanted HSVTI (160 µg gE-gI)·Part 1: HSVTI (40 µg gE-gI/AS01B)·Part 1: HSVTI (80 µg gE-gI/AS01B)·and 8 more
    All 13

    Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI) · Part 1: Non-adjuvanted HSVTI (80 µg gE-gI) · Part 1: Non-adjuvanted HSVTI (160 µg gE-gI) · Part 1: HSVTI (40 µg gE-gI/AS01B) · Part 1: HSVTI (80 µg gE-gI/AS01B) · Part 1: HSVTI (160 µg gE-gI/AS01B) · Part 1: HSVTI (40 µg gE-gI/AS01E) · Part 1: HSVTI (80 µg gE-gI/AS01E) · Part 1: HSVTI (160 µg gE-gI/AS01E) · Part 1: Placebo · Part 2: HSVTI (80 µg gE-gI/AS01B) · Part 2: HSVTI (80 µg gE-gI/AS01E) · Part 2: Placebo

    ; arms removed: Non-adjuvanted HSV formulation 1 - Part I Group·Non-adjuvanted HSV formulation 2 - Part I Group·Non-adjuvanted HSV formulation 3 - Part I Group·HSV formulation 1 with adjuvant 1 - Part I Group·HSV formulation 2 with adjuvant 1 - Part I Group·and 8 more
    All 13

    Non-adjuvanted HSV formulation 1 - Part I Group · Non-adjuvanted HSV formulation 2 - Part I Group · Non-adjuvanted HSV formulation 3 - Part I Group · HSV formulation 1 with adjuvant 1 - Part I Group · HSV formulation 2 with adjuvant 1 - Part I Group · HSV formulation 3 with adjuvant 1 - Part I Group · HSV formulation 1 with adjuvant 2 - Part I Group · HSV formulation 2 with adjuvant 2 - Part I Group · HSV formulation 3 with adjuvant 2 - Part I Group · Placebo - Part I Group · HSVTI formulation (F) 1 - Part II Group · HSVTI_F2 - Part II Group · Placebo - Part II Group

    + 4 other changes: index terms, verification date, description and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05298254
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 28, 2022
Start date
Mar 7, 2022
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Results posted
Nov 9, 2026
Last update
Nov 9, 2026

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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