A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males

July 28, 2025 updated by: Jun Zhang, Xiamen University

A Multicenter, Randomized, Double-Blind, Aluminum Adjuvant-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E. Coli) in Chinese Males Aged 18 to 45 Years

This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Provincial Center for Disease Control and Prevention
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Provincial Center for Disease Control and Prevention
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan Provincial Center for Disease Control and Prevention
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male participants aged 18-45 years at the time of the first vaccination.
  2. Be able to comprehend the trial procedures and comply with the protocol requirements (e.g., providing biological samples, completing diary/contact cards, and attending scheduled follow-up visits), and provide written informed consent.
  3. No more than 5 sexual partners so far.
  4. Participants who agree to adopt effective contraceptive measures within 30 days after each vaccination.
  5. No prior history of HPV-related anal-genital lesions (e.g., genital warts, penile/perineal/perianal intraepithelial neoplasia, penile/perineal/perianal cancer, anal intraepithelial neoplasia, and anal cancer).

Exclusion Criteria:

  1. Participants who have received or plan to receive any other HPV vaccine during the study period, or have participated in any other HPV-related clinical trial.
  2. Axillary temperature > 37.0°C.
  3. Engagement in sexual activity (including vaginal/anal intercourse, or any genital contact) within 48 hours prior to any swab/anal cytology specimen collection visit, or any other behavior that may affect the anal-genital examination and specimen collection (anal procedures only applicable to MSM participants).
  4. Presence of clinically vident genital warts, external genital lesions, or anal lesions which may suggest sexually transmitted diseases on the day of enrollment.
  5. Participants who received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy (≥14 consecutive days) within 6 months prior to enrollment, except local treatment (e.g., ointment, eyedrops, inhalants or nasal sprays).
  6. Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them within 7 months after the first dose.
  7. Use of any investigational or non-registered product (drug or vaccine) within 30 days prior to vaccination, or intending to use them or participate in another clinical trial during the study period.
  8. Administration of inactivated vaccine within 14 days or live vaccine within 21 days before vaccination.
  9. Any acute illness requiring systemic antibiotic or antiviral treatment within 5 days prior to vaccination, or axillary temperature ≥38.0°C within 3 days prior to vaccination.
  10. A state of immunocompromised condition as inquiried by study investigator, e.g., congenital or acquired immunodeficiency diseases, HIV infection, immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, or any other condition that may affect immune response), primary diseases or cancer of major organs (such as heart, liver, spleen, lungs, kidneys).
  11. History of severe allergy, including serious adverse reactions (e.g., dyspnea, angioedema) to any previous vaccination, or severe allergy to any component of the trial vaccine (recombinant VLP protein, sodium dihydrogen phosphate, disodium hydrogen phosphate, polysorbate, aluminum hydroxide).
  12. Asthma, with unstable condition over the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroid administration.
  13. History of hypertension or hypotension, not stably controlled despite regular medication, or systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or systolic blood pressure <90 mmHg, measured in both arms at rest.
  14. History of severe medical conditions (with unstable condition that may require emergency treatment or hospitalization), as inquiried by study investigator.
  15. Self-report past coagulation disorders or abnormal coagulation function.
  16. Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that did not require treatment in the past 3 years.
  17. Any medical, psychological, social, occupational, or other condition that may affect the conduct of the clinical trial, according to the investigator's judgment after medical history and physical examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)
Participants in this arm would receive Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli).
Biological: Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)
Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)
Placebo Comparator: Aluminum Adjuvant
Participants in this arm would receive Aluminum Adjuvant.
Biological: Aluminum Adjuvant
Participants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, Penile/Perineal/Perianal Intraepithelial Neoplasia 1+ (PIN1+), and Penile/Perineal/Perianal cancer (pooled across all specified HPV types)
Time Frame: 0-78 months
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, PIN1+ and Penile/Perineal/Perianal cancer (pooled across all specified HPV types) in the Per-Protocol Set (PPS) population.
0-78 months
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated Anal Intraepithelial Neoplasia 1+ (AIN1+) and Anal cancer (pooled across all specified HPV types), only in MSM participants
Time Frame: 0-78 months
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated AIN1+ and Anal cancer in the PPS population of MSM participants.
0-78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types)
Time Frame: 0-78 months
To evaluate the efficacy of the investigational vaccine in preventing HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types).
0-78 months
Seroconversion and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
Time Frame: 0-7 months
To evaluate the immunogenicity of the investigational vaccine.
0-7 months
Seropositivity and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 18, 30, 42, 54, 66 and 78
Time Frame: 18-78 months
To evaluate the long-term immunopersistence of the investigational vaccine.
18-78 months
Adverse events/reactions occurred within 30 days after each vaccination
Time Frame: Within 30 days (Day 0-30) after each vaccination
To evaluate the safety of the investigational vaccine.
Within 30 days (Day 0-30) after each vaccination
Serious adverse events occurred throughout the study
Time Frame: 0-78 months
To evaluate the safety of the investigational vaccine.
0-78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen University

Collaborators

Xiamen Innovax Biotech Co., Ltd

Investigators

  • Study Chair: Jun Zhang, master, Xiamen University
  • Principal Investigator: Xiaoqiang Liu, Ph.D., Yunnan Provincial Center for Disease Control and Prevention
  • Principal Investigator: Long Sui, Ph.D., Obstetrics & Gynecology Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

September 30, 2031

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-PRO-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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