AIN1, AIN2, AIN3, Anal Cancer, Genital Wart, HPV-Related Carcinoma, Penile Cancer, PIN-1, PIN2, PIN3
Conditions
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.
Interventions
BIOLOGICAL9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).
BIOLOGICALPlacebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).
Sponsors
Shanghai Bovax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese men aged 18-45 years who can provide legal identification and have a sexual life history; 2. Subjects fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent; 3. 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; 4. Heterosexual men subjects must have exclusively female sexual partners and no more than 5 before enrollment; 5. 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; 6. Subjects agree to provide effective contact information that can be used for communication with the researchers during the study; 7. 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; 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of genital wart | 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
| Measure | Time frame | Description |
|---|---|---|
| The combined incidence of PIN1/2/3 and Penile/perianal/perineal cancer | 0-72 month | 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. |
| The incidence of PI 12 | 0-72 month | 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. |
| The incidence of PI 6 | 0-72 month | 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. |
| The incidence of transient infection | 0-72 month | 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. |
| The combined incidence of AIN1/2/3 and anal cancer in MSM | 0-72 month | 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. |
| The incidence of solicited adverse events | 0-7 days after each dose of vaccine | The incidence of solicited adverse events within 30 minutes and 0-7 days after each dose of vaccine for all subjects; |
| The incidence of unsolicited adverse events | 0-30 days after each dose of vaccine | The incidence of unsolicited adverse events within 0-30 days after each dose of vaccine for all subjects; |
| The incidence of serious adverse events | 0-72 month | The incidence of all serious adverse events that occurred between the first dose and the last follow-up in all subjects. |
| Immunogenicity | 0-72 month | 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. |
Countries
China
Outcome results
None listed