ClinicalTrials.gg
CompletedNCT05518201Updated Apr 17, 2024

Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old

A Phase 1 interventional study of Placebo among 18-45 yrs and Placebo among 9-17 yrs in Penile Cancer, Anal Cancer and PIN-1, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Completed at 1 site in China. Open to male participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
9 Years to 45 Years
Sex
Male
01

Study summary

To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.

02

Conditions studied

  • Penile Cancer
  • Anal Cancer
  • PIN-1
  • PIN-2
  • PIN-3
  • AIN1
  • AIN2
  • AIN3
  • Genital Wart
03

In context

Penile Neoplasms

99 studies on the registry are indexed under Penile Neoplasms; 28 are open to participants now.

This study's enrollment of 90 is above the median of 37 across 81 interventional studies indexed under Penile Neoplasms.

Browse Penile Neoplasms studies →

Lead sponsor

Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 45 Years
Sexes eligible
Male
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. Healthy Chinese male aged 9 to 45 years; Provide legal identification; For those under the age of 18, they must also provide their guardian's legal identification;
  2. Adults voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an form;
  3. Subjects and/or their legal guardian are able to read and understand the study schedule, and commitment to regular follow-up as required by the study;
  4. Subjects will take effective from Day 0 to month 7 (For Male: celibate, wear a condom, vasectomy, etc. ; For Female Sexual Partners: use IUD, oral/injecting/Slow-release topical contraceptives (except emergency contraceptives), Hormone patches, sterilization, contraceptive diaphragm, etc.

Exclusion criteria

Exclusion Criteria:

  1. Subjects aged over 14 years on the day of enrolment had fever (axillary temperature≥37.3℃) within 24 hours prior to the first dose of vaccination; subjects aged≤14 had fever within 24 hours prior to the first dose of vaccination (axillary temperature≥37.5℃);
  2. Poor controlled hypertension, i.e., after lifestyle modification and/or treated (aged 9 to 17 years: systolic BP≥120mmHg and/or diastolic BP≥80mmHg; aged 18 to 45 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
  3. Had received marketed HPV vaccine; plan to receive marketed HPV vaccine during this study period; have enrolled in HPV vaccine clinical trials and have received trial vaccine/placebo;
  4. History of positive test to HPV (including types not covered by 9vHPV vaccine);
  5. History of external genital disease (e.g. genital warts, penis/perianal region/perineum intraepithelial neoplasia, penile/perianal/perineal cancer), diseases within the anus (e.g. anal intraepithelial neoplasia and anal cancer), or history of head and neck cancer;
  6. Present history of severe liver and kidney disease, severe CVDs, severe hypertension, diabetic complications, or history of malignant tumour;
  7. History of convulsions (except fever convulsions in children under 2 years of age), epilepsy, brain diseases, mental illness, or family history;
  8. With prohibitive to intramuscular injection, such as Thrombocytopenia, coagulopathy, or being treated with anticoagulants;
  9. Asplenic, functionally asplenic, or splenectomy caused by any condition;
  10. History of severe allergic reactions requiring medical intervention (e.g., anaphylactic shock, allergic laryngeal edema, Anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.); History of severe side effects or a history of severe allergies to any of the components of the vaccine (Histidine, Polysorbate 80, Aluminum Phosphate Adjuvant);
  11. History of congenital/acquired immunodeficiency, such as lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, Inflammatory bowel disease, or other diseases, etc.; Received treatment within 6 months before vaccination, such as long-term use (Dosage reference: equivalent to prednisone 20mg per day, more than one week); Or monoclonal antibodies; Or thymus peptides; Or interferon, etc.; Or plan to receive such products during this study period (From Day 0 to Month 7); Allow topical medication (e.g., ointments, eye drops, inhalants, or nasal sprays, etc.);
  12. Present history of infectious diseases, such as Tuberculosis (TB), Hepatitis, infection, and/or TeponemaPllidum infection;
  13. Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
  14. Inactivated/recombinant/nucleic acid vaccines, etc. (non-attenuated vaccines) have been given within 14 days before enrollment; or have been vaccinated within 28 days of attenuated vaccines; or have received immunoglobulin products or blood-related products within 3 months before enrollment;
  15. Received other investigative or unregistered products within 30 days before vaccination or plan to receive such products during this study period; Or still participating in other clinical trial within 3 months prior to enroll this study;
  16. Plan to receive immunoglobulin products or blood-related products during this study period (From Day 0 to Month 7);
  17. Plan to relocate permanently from the area before the end of the study or leave the local area for a long time during the study visit (affecting the scheduled visit time);
  18. Abnormal laboratory testing indicators specified in study protocol (except NCS);
  19. According to the investigator's judgment, the subjects had any condition that were not suitable for participation in this study.
Terms in these criteria, in plain language(7)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    The 9vHPV Recombinant Vaccine among 18-45yrs

    Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).

    Biological: Placebo among 18-45 yrs

  • Experimental
    The 9vHPV Recombinant Vaccine among 9-17 yrs

    Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).

    Biological: Placebo among 9-17 yrs

Interventions

  • BiologicalPlacebo among 18-45 yrs

    Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).

  • BiologicalPlacebo among 9-17 yrs

    Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).

06

What researchers measure

Primary outcomes

  1. Number of subjects with Adverse Events (AEs)

    Subjects with solicited and unsolicited AEs

    Time frame: From Day 0 to Month 7

  2. Number of subjects with Severe adverse events (SAE)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

    Time frame: From Day 0 to Month 12

Secondary outcomes

  1. Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT)

    Immunogenicity were assessed by the GMT of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45

    Time frame: day 31 post last dose

  2. Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate

    Immunogenicity were assessed by the seroconversion rate of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination

    Time frame: day 31 post last dose

  3. Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by IgG antibody GMT and seroconversion rate

    Immunogenicity were assessed by the seroconversion rate and GMT of anti HPV6/11/16/18/33/45/52/58 IgG antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination

    Time frame: day 31 post last dose

  4. The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies

    Immunogenicity were assessed by the seroconversion rate and GMT (4-fold increase rate) of anti HPV6/11/16/18/33/45/52/58 IgG and neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seropositive before vaccination

    Time frame: day 31 post last dose

07

Study locations

1 site
  • Center for Disease Control and Prevention
    Mianzhu, Sichuan, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Nov 2023, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2022
First posted
Aug 26, 2022
StartActual
Sep 23, 2022
Primary completionActual
Nov 20, 2023
CompletionActual
Nov 20, 2023
Last update
Apr 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05518201
Lead sponsor
Shanghai Bovax Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Aug 26, 2022
Start date
Sep 23, 2022
Primary completion
Nov 20, 2023
Completion
Nov 20, 2023
Last update
Apr 17, 2024

Study contacts

Ting Huang
study director · Sichuan Provincial Center for Disease Control and Prevention

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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