A Phase 1 interventional study of HSVTI Formulation 1 and HSVTI Formulation 2 in Herpes Simplex, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.
166 studies on the registry are indexed under Herpes Simplex; 12 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 113 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →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.
Counted across the registry records on this site, refreshed daily.
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.
Women of childbearing potential may be enrolled in the study, if the participant:
Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally at the discretion of the investigator to confirm non- according to local laboratory reference range.
Exclusion Criteria:
Medical conditions:
Acute or chronic pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Hypersensitivity to latex.
Prior/Concomitant therapy:
Planned administration or administration of a vaccine* in the period starting 15 days* before each dose and ending 15 days* after each dose of study intervention administration**.
* In case of adjuvanted and , this time window is to be increased to 30 days before and after each dose.
Prior/Concurrent clinical study experience:
Other exclusions:
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.
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.
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
Biological: HSVTI Formulation 1
HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
Biological: HSVTI Formulation 2
HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
Biological: Placebo
This investigational intervention was administered intramuscularly to HSVTI_F1 Group.
This investigational intervention was administered intramuscularly to HSVTI_F2 Group.
This intervention was administered intramuscularly to Placebo group.
Number of Participants Reporting Any Solicited Administration Site Events
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Administration Site Events
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Solicited Systemic Events
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever \[temperature \>=38.0-degree Celsius (°C)\]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Systemic Events
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature \>= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Medically Attended Events (MAEs)
MAEs are defined as AEs requiring medically attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs)
plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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 1 (pre-study intervention administration)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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 (7 days post dose 1)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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 (28 days post dose 1)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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 (7 days post dose 2)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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 (28 days post dose 2)
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
The geometric mean of HSVTI CD4+T cells frequency expressing at least 2 markers including at least one cytokine among Interferon \[IFN\]-gamma, Tumour necrosis factor \[TNF\]-alpha, Interleukin \[IL\]-2, IL-13, IL-17, 4-1BB and CD40L were assessed by Intracellular staining (ICS).
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
The geometric mean of HSVTI CD8+ T cells frequency expressing at least 2 activation markers including at least one cytokine among IFN-gamma, TNF-alpha, IL-2, IL-13, IL- 17, 4-1BB and CD40L were assessed by ICS.
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Number of Participants Reporting Any MAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any SAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Newly Diagnosed pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
| Milestone | Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Started | 20 | 20 | 10 |
| Completed | 17 | 20 | 10 |
| Not completed | 3 | 0 | 0 |
| Withdrew: Adverse event | 3 | 0 | 0 |
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Erythema | 8 | 2 | 0 |
| Pain | 19 | 18 | 4 |
| Swelling | 4 | 3 | 0 |
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Erythema | 2 | 4 | 0 |
| Pain | 15 | 14 | 0 |
| Swelling | 4 | 2 | 0 |
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever \[temperature \>=38.0-degree Celsius (°C)\]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Arthralgia | 6 | 5 | 0 |
| Fatigue | 16 | 6 | 1 |
| Headache | 10 | 5 | 2 |
| Myalgia | 11 | 8 | 1 |
| Fever | 3 | 1 | 0 |
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature \>= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Arthralgia | 6 | 4 | 0 |
| Fatigue | 13 | 7 | 1 |
| Headache | 7 | 2 | 1 |
| Myalgia | 9 | 5 | 0 |
| Fever | 5 | 0 | 0 |
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 4 | 4 | 4 |
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Unsolicited AEs | 4 | 3 | 2 |
MAEs are defined as AEs requiring medically attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Medically Attended Events (MAEs) | 1 | 1 | 3 |
An SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | 0 | 0 | 0 |
plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs) | 0 | 0 | 0 |
Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 | 0 | 0 |
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| ALT — Below | 0 | 0 | 0 |
| ALT — Within | 20 | 20 | 10 |
| ALT — Above | 0 | 0 | 0 |
| AST — Below | 0 | 0 | 0 |
| AST — Within | 20 | 20 | 10 |
| AST — Above | 0 | 0 | 0 |
| Creatinine — Below | 0 | 0 | 0 |
| Creatinine — Within | 20 | 20 | 10 |
| Creatinine — Above | 0 | 0 | 0 |
| Urea Nitrogen — Below | 2 | 2 | 2 |
| Urea Nitrogen — Within | 18 | 18 | 8 |
| Urea Nitrogen — Above | 0 | 0 | 0 |
| Hemoglobin — Below | 8 | 3 | 2 |
| Hemoglobin — Within | 12 | 17 | 8 |
| Hemoglobin — Above | 0 | 0 | 0 |
| Platelets — Below | 0 | 0 | 0 |
| Platelets — Within | 20 | 20 | 10 |
| Platelets — Above | 0 | 0 | 0 |
| WBC — Below | 0 | 1 | 0 |
| WBC — Within | 19 | 19 | 10 |
| WBC — Above | 1 | 0 | 0 |
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| ALT — Below | 0 | 0 | 0 |
| ALT — Within | 20 | 19 | 10 |
| ALT — Above | 0 | 1 | 0 |
| AST — Below | 0 | 0 | 0 |
| AST — Within | 20 | 20 | 10 |
| AST — Above | 0 | 0 | 0 |
| Creatinine — Below | 1 | 0 | 0 |
| Creatinine — Within | 19 | 20 | 10 |
| Creatinine — Above | 0 | 0 | 0 |
| Urea Nitrogen — Below | 2 | 1 | 2 |
| Urea Nitrogen — Within | 18 | 18 | 8 |
| Urea Nitrogen — Above | 0 | 1 | 0 |
| Hemoglobin — Below | 6 | 5 | 2 |
| Hemoglobin — Within | 14 | 15 | 8 |
| Hemoglobin — Above | 0 | 0 | 0 |
| Platelets — Below | 0 | 0 | 0 |
| Platelets — Within | 20 | 20 | 10 |
| Platelets — Above | 0 | 0 | 0 |
| WBC — Below | 0 | 2 | 1 |
| WBC — Within | 20 | 18 | 9 |
| WBC — Above | 0 | 0 | 0 |
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| ALT — Below | 0 | 0 | 0 |
| ALT — Within | 17 | 19 | 10 |
| ALT — Above | 0 | 1 | 0 |
| AST — Below | 0 | 0 | 0 |
| AST — Within | 17 | 20 | 10 |
| AST — Above | 0 | 0 | 0 |
| Creatinine — Below | 1 | 0 | 0 |
| Creatinine — Within | 16 | 20 | 10 |
| Creatinine — Above | 0 | 0 | 0 |
| Urea Nitrogen — Below | 1 | 1 | 1 |
| Urea Nitrogen — Within | 16 | 19 | 9 |
| Urea Nitrogen — Above | 0 | 0 | 0 |
| Hemoglobin — Below | 9 | 5 | 2 |
| Hemoglobin — Within | 8 | 15 | 8 |
| Hemoglobin — Above | 0 | 0 | 0 |
| Platelets — Below | 0 | 0 | 0 |
| Platelets — Within | 17 | 20 | 10 |
| Platelets — Above | 0 | 0 | 0 |
| WBC — Below | 1 | 1 | 0 |
| WBC — Within | 15 | 19 | 10 |
| WBC — Above | 1 | 0 | 0 |
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| ALT — Below | 0 | 0 | 0 |
| ALT — Within | 17 | 19 | 10 |
| ALT — Above | 0 | 1 | 0 |
| AST — Below | 0 | 0 | 0 |
| AST — Within | 17 | 20 | 10 |
| AST — Above | 0 | 0 | 0 |
| Creatinine — Below | 2 | 0 | 1 |
| Creatinine — Within | 15 | 20 | 9 |
| Creatinine — Above | 0 | 0 | 0 |
| Urea Nitrogen — Below | 1 | 2 | 0 |
| Urea Nitrogen — Within | 15 | 18 | 10 |
| Urea Nitrogen — Above | 1 | 0 | 0 |
| Hemoglobin — Below | 6 | 4 | 2 |
| Hemoglobin — Within | 11 | 16 | 8 |
| Hemoglobin — Above | 0 | 0 | 0 |
| Platelets — Below | 0 | 0 | 0 |
| Platelets — Within | 17 | 20 | 10 |
| Platelets — Above | 0 | 0 | 0 |
| WBC — Below | 2 | 2 | 0 |
| WBC — Within | 14 | 18 | 10 |
| WBC — Above | 1 | 0 | 0 |
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine, Urea nitrogen). 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.
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| ALT — Below | 0 | 0 | 0 |
| ALT — Within | 17 | 20 | 10 |
| ALT — Above | 0 | 0 | 0 |
| AST — Below | 0 | 0 | 0 |
| AST — Within | 17 | 20 | 10 |
| AST — Above | 0 | 0 | 0 |
| Creatinine — Below | 2 | 2 | 0 |
| Creatinine — Within | 15 | 18 | 10 |
| Creatinine — Above | 0 | 0 | 0 |
| Urea Nitrogen — Below | 3 | 1 | 1 |
| Urea Nitrogen — Within | 14 | 18 | 8 |
| Urea Nitrogen — Above | 0 | 1 | 1 |
| Hemoglobin — Below | 8 | 6 | 1 |
| Hemoglobin — Within | 9 | 14 | 9 |
| Hemoglobin — Above | 0 | 0 | 0 |
| Platelets — Below | 0 | 0 | 0 |
| Platelets — Within | 17 | 20 | 10 |
| Platelets — Above | 0 | 0 | 0 |
| WBC — Below | 1 | 2 | 0 |
| WBC — Within | 16 | 18 | 10 |
| WBC — Above | 0 | 0 | 0 |
The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).
| Percentage of participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Day 1 | 20.0 (5.7 to 43.7) | 25.0 (8.7 to 49.1) | 20.0 (2.5 to 55.6) |
| Day 29 | 100 (80.5 to 100.0) | 100 (83.2 to 100.0) | 20.0 (2.5 to 55.6) |
| Day 57 | 100 (80.5 to 100.0) | 100 (83.2 to 100.0) | 20.0 (2.5 to 55.6) |
| EU/mL | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Day 1 | 1.2 (0.5 to 2.8) | 1.0 (0.5 to 2.0) | 1.1 (0.3 to 3.5) |
| Day 29 | 270.1 (176.5 to 413.4) | 197.8 (134.6 to 290.7) | 1.1 (0.3 to 3.8) |
| Day 57 | 558.8 (331.4 to 942.2) | 390.8 (221.9 to 688.3) | 1.1 (0.3 to 4.0) |
The geometric mean of HSVTI CD4+T cells frequency expressing at least 2 markers including at least one cytokine among Interferon \[IFN\]-gamma, Tumour necrosis factor \[TNF\]-alpha, Interleukin \[IL\]-2, IL-13, IL-17, 4-1BB and CD40L were assessed by Intracellular staining (ICS).
| HSVTI-specifc CD4+ T cells/10^6 cells | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Day 1 | 64.0 ± 0.9 | 36.3 ± 1.0 | 24.0 ± 0.9 |
| Day 29 | 456.8 ± 0.5 | 199.1 ± 0.8 | 21.1 ± 1.1 |
| Day 57 | 5899.7 ± 0.4 | 2932.3 ± 0.4 | 40.3 ± 1.0 |
The geometric mean of HSVTI CD8+ T cells frequency expressing at least 2 activation markers including at least one cytokine among IFN-gamma, TNF-alpha, IL-2, IL-13, IL- 17, 4-1BB and CD40L were assessed by ICS.
| HSVTI-specifc CD8+ T cells/10^6 cells | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Day 1 | 37.6 ± 0.8 | 19.6 ± 0.9 | 8.7 ± 0.8 |
| Day 29 | 27.1 ± 1.0 | 9.5 ± 0.8 | 8.6 ± 0.7 |
| Day 57 | 61.0 ± 0.9 | 20.8 ± 0.8 | 13.5 ± 0.9 |
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any MAEs | 3 | 1 | 4 |
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any SAEs | 0 | 0 | 0 |
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Newly Diagnosed pIMDs | 0 | 0 | 0 |
| Participants | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 | 0 | 0 |
Collected over Solicited AEs: during the 7-day follow-up period after any vaccination. Unsolicited AEs: during the 28-day follow-up period after any vaccination. All- cause mortality, SAEs, MAEs and plMDs (newly diagnosed and pre-existing pIMDs): from first vaccination (Day 1) up to study end (Day 209). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HSVTI_F1 Group | 0/20 (0%) | 0/20 (0%) | 20/20 (100%) |
| HSVTI_F2 Group | 0/20 (0%) | 0/20 (0%) | 20/20 (100%) |
| Placebo Group | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group |
|---|---|---|---|
| Administration site painGeneral disorders | 19/20 | 19/20 | 4/10 |
| FatigueGeneral disorders | 18/20 | 10/20 | 1/10 |
| MyalgiaMusculoskeletal and connective tissue disorders | 15/20 | 8/20 | 1/10 |
| HeadacheNervous system disorders | 12/20 | 6/20 | 2/10 |
| Administration site erythemaGeneral disorders | 9/20 | 4/20 | 0/10 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/20 | 5/20 | 0/10 |
| PyrexiaGeneral disorders | 7/20 | 1/20 | 2/10 |
| Administration site swellingGeneral disorders | 5/20 | 4/20 | 0/10 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/20 | 1/20 | 2/10 |
| ChillsGeneral disorders | 3/20 | 2/20 | 0/10 |
| Age, Continuous(YEARS) | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group | Total |
|---|---|---|---|---|
| Mean | 29.9 ± 8.0 | 27.2 ± 6.7 | 31.4 ± 6.6 | 29.1 ± 7.3 |
| Sex: Female, Male(Participants) | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group | Total |
|---|---|---|---|---|
| Female | 11 | 11 | 6 | 28 |
| Male | 9 | 9 | 4 | 22 |
| Race/Ethnicity, Customized(Participants) | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group | Total |
|---|---|---|---|---|
| ASIAN - JAPANESE HERITAGE | 20 | 20 | 10 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
Ran from Aug 2023 to primary completion in Nov 2023, 3 months.
Results were first posted in Jun 2025, 1 year 6 months after primary completion.
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