HPV InfectioN, HPV-Related Carcinoma
Conditions
Keywords
HPV Infection HPV vaccine
Brief summary
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Interventions
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
BIOLOGICALplacebo
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
Sponsors
National Vaccine and Serum Institute, China
Chengdu Institute of Biological Products Co.,Ltd.
Simoon Record Pharma Information Consulting Co., Ltd.
Beijing Kantorico Statistical Technology Co., Ltd.
Guangxi Center for Disease Control and Prevention
Hunan Provincial Center for Disease Control and Prevention
Sichuan Center for Disease Control and Prevention
Centers for Disease Control and Prevention, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- non-gynecological related 1. \*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification; 2. \*Axillary body temperature \<37.3℃ on the day of enrollment; 3. The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent; 4. Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits; 5. No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of; 6. The subject has a negative urine pregnancy test on the day before vaccination. \- Gynecology related 7. \*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan. 8. \*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Person-years incidence of CIN2+ associated with HPV6/11/16/18. | 1 month after 3 doses of vaccine |
| Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68 | 1 month after 3 doses of vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types. | 1 month after 3 doses of vaccine | — |
| Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58 | 1 month after 3 doses of vaccine | — |
| Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6 | 1 month after 3 doses of vaccine | — |
| Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+). | 1 month after 3 doses of vaccine | — |
| Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18 | After at least 1 dose of vaccine | — |
| Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68 | After at least 1 dose of vaccine | — |
| Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types. | After at least 1 dose of vaccine | — |
| AE incidence and severity distribution | The first dose of vaccination to within 1 month after the full vaccination | — |
| SAE incidence | During the study，an average of 6 year | — |
| Number of pregnant | The first dose of vaccination to within 6 months after the full vaccination | — |
| Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form) | The first dose of vaccination to within 6 months after the full vaccination | Previous pregnancy, current pregnancy mode, neonatal information |
| To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula) | 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination | — |
| To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula) | 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination | — |
Countries
China
Contacts
CONTACTZhaojun Mo
Outcome results
None listed