A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years

Shanghai Bovax Biotechnology Co., Ltd.1 site in 1 country3,131 target enrollmentDecember 9, 2022

ConditionsCervical Cancer Genital Wart CIN1 CIN2 CIN3 Vain I Vain III Vin I Vin II Vin III AIS VAIN - Vaginal Intraepithelial Neoplasia 2

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Enrollment: 3131
Locations: 1
Primary Endpoint: The person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago.
Status: Terminated
Last Updated: 2 years ago

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 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

Registry

clinicaltrials.gov

Start Date

December 9, 2022

End Date

March 23, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(IF Non-compliance with criterion "\*" option, the visit WILL be rescheduled)
•Chinese women aged 18-45 who can provide legal identification and had a sexual life history;
•The subject fully understands the study procedures, understands the risks and benefits associated related this 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 regular follow-up visits according to the study protocol;
•\*axillary's temperature \<37.3℃ on the day of enrollment;
•Subjects have not received any form of cervical cancer screening, or have been received 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;
•When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml β-HCG), they were not in the lactation period, had no family planning from Day 0 to 30 days after receiving the third dose of the vaccine. Agree to continue to use effective contraception (including: oral contraceptives, injectable or embedded contraceptives, sustained-release topical contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.) from the day of enrollment to 30 days after the third season of vaccination. Safe-period contraception, in vitro ejaculation, and emergency contraception are unacceptable methods of contraception.

Exclusion Criteria

•(IF Non-compliance with criterion "\*" option, the visit WILL be rescheduled)
•Blood pressure (BP) before the first dose of vaccination was higher than normal or increased (systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg);
•\* Subjects had fever symptoms (axillary's temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);
•History of severe side effect to previous vaccinations or History of severe allergies (e.g. Swelling of the mouth and throat, Dyspnea, Hypotension or Shock, Severe urticaria) to components of study vaccine (e.g. Histidine, Polysorbate, and Aluminium phosphate). History of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
•Subjects with compromised immune systemsor have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or Autoimmune thyroid disease （e.g. Hyperthyroidism，Thyroiditis/Subacute thyroiditis，or Hypothyroidism), and other Autoimmune diseases ;
•Previous or current have epilepsy, seizures (except febrile seizures in children) or convulsions, or mental diseases, with a family history of psychosis;
•Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
•Previous or current have severe liver, kidney and cardiovascular diseases, diabetic complications or malignant tumor;
•Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;
•Immunosuppressant or immunopotentiator therapy within 1 month before the first dose of vaccination, such as long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks, such as prednisone or similar drugs;Topical administration (such as ointment, eye drops, inhalant or nasal spray) exceeding the recommended dosage in the directions or showing any signs of systemic exposure) or planning to receive such treatment between the day of the first dose and 30 days after the third dose of the vaccine;

Outcomes

Primary Outcomes

The person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago.

Time Frame: Over 30 months

Secondary Outcomes

Percentage of Participants Who Report at any Injection-site and Systemic Adverse Event 30 minutes post any vaccination(30 minutes after any dose of vaccination)
Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by SCR(Month7)
The person-year incidence of HPV 6-, 11-, 16-, and 18-related 6-month Persistent Infection at least 30 days post Dose 3(from Month 7 up to Month 60)
The person-year incidence of HPV 6-, 11-, 16-, and 18-related 12-month Persistent Infection at least 30 days post Dose 3(from Month 7 up to Month 60)
Number of subjects with Adverse Events (AEs)(From Day 0 to Month 30)
The neutralizing antibody level among the subjects receiving the whole schedule vaccination(Month7)
The person-year incidence of non-vaccine-realted HPV types related CIN2+ observed in Chinese women aged 18-45 years at least 30 days post Dose 3(Through study completion，expected 60 months)
The person-year incidence of non-vaccine-realted HPV types related disease (e.g., VIN1+ or AIN1+ or VAIN1+ and genital warts) observed in Chinese women aged 18-45 years at least 30 days post Dose 3(Through study completion，expected 60 months)
The person-year incidence of HPV 6-, 11-, 16-, and 18-related 6-month and 12-month Persistent Infection at least 30 days post Dose 1(From Month 1 up to Month 60)
The person-year incidence of HPV 6-, 11-, 16-, and 18-related disease (e.g., VIN1+ orAIN1+ or VAIN1+ and genital warts)(from Month 7 up to Month 60)
The person-year incidence of HPV 6-, 11-, 16- and 18-related diseases (e.g., VIN1+ or AIN1+ or VAIN1+ and genital warts) at least 30 days post Dose 1(From Month 1 up to Month 60)
Number of subjects with Severe adverse events (SAE)(Through study completion，expected 60 months)
Number of subjects with pregnancy events(Through study completion，expected 60 months)
The person-year incidence of HPV 16- and 18-related CIN2+ at least 30 days post Dose 1(From Month 1 up to Month 60)