A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

Shanghai Bovax Biotechnology Co., Ltd.1 site in 1 country8,000 target enrollmentApril 28, 2020

ConditionsCervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Enrollment: 8000
Locations: 1
Primary Endpoint: The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

Registry

clinicaltrials.gov

Start Date

April 28, 2020

End Date

September 15, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(If the "\*" option is not met during screening, the visit can be rescheduled)
•Chinese women aged 20-45 who can provide legal identification and have a sexual life history;
•The subject 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 application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements;
•Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal;
•\*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including anal, vaginal, or genital/genital contact of the same or opposite sex) for 48 hours prior to any visit that includes gynecological sample collection, and to refrain from vaginal flushing, vaginal cleansing, or use of vaginal medications or preparations for 72 hours;
•When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml cox-hcg), they were not in the lactation period and had no family planning within 7 months after enrollment (1 month before whole-course inoculation).2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures include: the pill, injection or embedded contraception, slow-release local birth control pills, hormone patch, the intrauterine device (IUD), sterilization, abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and emergency contraception is unacceptable contraception;
•\*body temperature \<37.3℃ (underarm body temperature)

Exclusion Criteria

•First dose exclusion criteria(If the "\*" option is met during screening, the visit can be rescheduled)
•Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine and have received a vaccine/placebo vaccination;
•Previous positive history of HPV;
•Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H), atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;
•Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.);
•Received total hysterectomy or pelvic radiotherapy;
•Cervical insufficiency or abnormal cervical structure (judged by the results of routine gynecological examination);
•Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal) or have obvious condyloma;
•A history of seizures, convulsions or convulsions, or a family history of mental illness;
•Have participated in other gynecology-related clinical trials within 6 months, and have used or plan to use other investigational or unregistered products (drugs or vaccines) other than the vaccine in this study within 3 months;

Outcomes

Primary Outcomes

The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3

Time Frame: 1 month post vaccination 3 (Month 7) up to Month 84

Secondary Outcomes

The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination(7 days post any vaccination)
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination(30 minutes post any vaccination)
Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study(1 month post vaccination 3 (Month 7) up to Month 84)
neutralizing antibody level(30 days post third dose of vaccination)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3(1 month post vaccination 3 (Month 7) up to Month 84)
The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1(1 month post vaccination 1 up to Month 84)
Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination(30 days post any vaccination)