A Randomized, Double-blinded, Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine (Hansenula Polymorpha) in Chinese Males Aged 18-45 Years
Overview
- Phase
- Phase 3
- Intervention
- 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
- Conditions
- Genital Wart
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Enrollment
- 9000
- Locations
- 5
- Primary Endpoint
- The incidence of genital wart
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.
Detailed Description
The primary aim of this clinical trial is to evaluate the efficacy of the 9-valent HPV vaccine in men aged 18-45 years old. It will also learn about the safety and immunogenicity of the 9-valent HPV vaccine. Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0, 2, 6 month immunization program. Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information, keeping a diary of their symptoms and medications.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chinese men aged 18-45 years who can provide legal identification and have a sexual life history;
- •Subjects fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;
- •Subjects are able to read, understand and fill in the research application forms such as diary CARDS and contact CARDS, and promise to participate in regular follow-up according to the study requirements;
- •Heterosexual men subjects must have exclusively female sexual partners and no more than 5 before enrollment;
- •MSM subject must have had sex with men within the past year (either insertive or receptive anal intercourse); and the cumulative number of sexual partners (including male and female sexual partners) does not exceed 5 before enrollment;
- •Subjects agree to provide effective contact information that can be used for communication with the researchers during the study;
- •Subjects consent to external anogenital lesion inspection and sample collection (including but not limited to wet swab collection and necessary biopsy) during the study period;
- •Subjects agree to take effective contraceptive measures from the first dose to 1 month after the last dose \[male effective contraception including abstinence, male condom, vasectomy, etc.; female valid contraception including the pill (excluding emergency contraception), injection or embedded contraception, sustained-release topical contraceptives, hormonal patch, intrauterine devices (IUD), sterilization, diaphragm, cervical caps, etc.; safe period contraception, extracorporeal ejaculation, and emergency contraception are unacceptable contraception.\]
Exclusion Criteria
- •Initial inoculation exclusion criteria (If the "\*" option is met during screening, the enrollment can be postponed and the re-screening can be rescheduled )
- •\* Subjects with axillary temperature ≥37.3℃ 24 hours before the first vaccination;
- •\* Higher blood pressure on the day of the first vaccination (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);
- •\* Sexual activity (including anal, vaginal/genital contact of the same or opposite sex) within 48 hours prior to the sampling visit; Self-shave hair from genital area within 24 hours prior to the genital examination visit (and/or using any post-shaving lotions or lubricants);
- •Have been or planned to be vaccinated with commercially available HPV vaccine; Have participated in or plan to participate in other HPV vaccine clinical trials;
- •Previous positive HPV test results (including types not included in the investigational vaccine) or related cytological abnormalities；
- •Previous or current HPV-related genital warts, penile/perianal/perineal intraepithelial neoplasia, penile/perianal/perineal cancer, anal intraepithelial neoplasia, or anal cancer;
- •Significant clinical evidence of external genital lesions and anal diseases (only MSM) suggesting the HPV infection during the external anogenital inspection before the first vaccination;
- •\* Acute illness or acute episode of chronic disease, or use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to vaccination;
- •\* Received inactivated/recombinant/nucleic acid vaccine (non-attenuated vaccine) within 7 days prior to recruitment, or attenuated vaccine within 14 days prior to enrollment;
Arms & Interventions
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) vaccine
Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha). Follow-up for the study encompassed Month 7 through Month 72.
Intervention: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Placebo
Participants in this arm would receive Placebo. Follow-up for the study encompassed Month 7 through Month 72.
Intervention: Placebo
Outcomes
Primary Outcomes
The incidence of genital wart
Time Frame: 0-72 month
The incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related genital wart in male subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.
Secondary Outcomes
- The incidence of solicited adverse events(0-7 days after each dose of vaccine)
- The incidence of PI 6(0-72 month)
- The incidence of unsolicited adverse events(0-30 days after each dose of vaccine)
- The combined incidence of AIN1/2/3 and anal cancer in MSM(0-72 month)
- The combined incidence of PIN1/2/3 and Penile/perianal/perineal cancer(0-72 month)
- The incidence of serious adverse events(0-72 month)
- Immunogenicity(0-72 month)
- The incidence of PI 12(0-72 month)
- The incidence of transient infection(0-72 month)