A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males
NCT Number: NCT06465914
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Genital Wart|Penile Cancer|Anal Cancer|PIN-1|PIN2|PIN3|AIN1|AIN2|AIN3|HPV-Related Carcinoma
Interventions: BIOLOGICAL: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)|BIOLOGICAL: Placebo
Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 9000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-11
Completion Date: 2030-07-30
Locations: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, China|Hunan Center for Disease Control and Prevention, Changsha, Hunan, 410153, China|Shanxi Provincial Disease for Control and Prevention, Taiyuan, Shanxi, China|Sichuan Center for Disease Control and Prevention, Chengdu, Sichuan, China|Yunnan Center for Disease Control and Prevention, Kunming, Yunnan, China

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.

Primary Outcome Measures: The incidence of genital wart, 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., 0-72 month
Secondary Outcome Measures: The combined incidence of AIN1/2/3 and anal cancer in MSM, The combined incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related AIN1/2/3 and anal cancer in MSM subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization., 0-72 month|The combined incidence of PIN1/2/3 and Penile/perianal/perineal cancer, The composite incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related PIN1/2/3 and Penile/perianal/perineal cancer in male subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization., 0-72 month|The incidence of PI 12, The incidence of 12-month persistent HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization., 0-72 month|The incidence of PI 6, The incidence of 6-month persistent HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization., 0-72 month|The incidence of transient infection, The incidence of transient HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization., 0-72 month|Immunogenicity, Immunogenicity: Geometric mean titer (GMTs) of HPV vaccine type-related neutralizing antibodies (pseudoviral neutralizing antibody assay) and lgG antibodies (ELISA assay) of subjects at day 0, 30-day after full immunization, 12, 36, and 72 months, and serological conversion rate (SCR) was calculated., 0-72 month|The incidence of solicited adverse events, The incidence of solicited adverse events within 30 minutes and 0-7 days after each dose of vaccine for all subjects;, 0-7 days after each dose of vaccine|The incidence of unsolicited adverse events, The incidence of unsolicited adverse events within 0-30 days after each dose of vaccine for all subjects;, 0-30 days after each dose of vaccine|The incidence of serious adverse events, The incidence of all serious adverse events that occurred between the first dose and the last follow-up in all subjects., 0-72 month