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

NCT06866574 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: HPV-PRO-015
• Study Type: interventional
• Target: 9,300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Penile/Perineal /Perianal Intraepithelial Neoplasia; Anal Intraepithelial Neoplasia; Penile/Perianal/Perineal Cancer; Anal Cancer; Genital Warts

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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 Outcomes (5)

• 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

  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

  18-78 months

• Adverse events/reactions occurred within 30 days after each vaccination

  Within 30 days (Day 0-30) after each vaccination

• Serious adverse events occurred throughout the study

  0-78 months

Study Arms (2)

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)

EXPERIMENTAL

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)

Aluminum Adjuvant

PLACEBO COMPARATOR

Participants in this arm would receive Aluminum Adjuvant.

Biological: Aluminum Adjuvant

Interventions

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli) BIOLOGICAL

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)

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)

Aluminum Adjuvant BIOLOGICAL

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).

Aluminum Adjuvant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants aged 18-45 years at the time of the first vaccination.
• 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.
• No more than 5 sexual partners so far.
• Participants who agree to adopt effective contraceptive measures within 30 days after each vaccination.
• 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).

You may not qualify if:

• 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.
• Axillary temperature \> 37.0°C.
• 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).
• Presence of clinically vident genital warts, external genital lesions, or anal lesions which may suggest sexually transmitted diseases on the day of enrollment.
• 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).
• Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them within 7 months after the first dose.
• 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.
• Administration of inactivated vaccine within 14 days or live vaccine within 21 days before vaccination.
• 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.
• 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).
• 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).
• Asthma, with unstable condition over the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroid administration.
• 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.
• History of severe medical conditions (with unstable condition that may require emergency treatment or hospitalization), as inquiried by study investigator.
• Self-report past coagulation disorders or abnormal coagulation function.

Sponsors & Collaborators

• Xiamen University: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator

Study Sites (4)

Fujian Provincial Center for Disease Control and Prevention

Fuzhou, Fujian, China

Location

Sichuan Provincial Center for Disease Control and Prevention

Chengdu, Sichuan, China

Location

Yunnan Provincial Center for Disease Control and Prevention

Kunming, Yunnan, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Anus Neoplasms; Condylomata Acuminata

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Jun Zhang, Master

  Xiamen University

  STUDY CHAIR

• Xiaoqiang Liu, Ph.D.

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Long Sui, Ph.D.

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 10, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (4)