A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the 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 Aged16-26 Years

Shanghai Bovax Biotechnology Co., Ltd.1 site in 1 country1,200 target enrollmentSeptember 19, 2020

ConditionsHPV Infections Cervical 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: HPV Infections
Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Enrollment: 1200
Locations: 1
Primary Endpoint: The seroconversion rate of neutralizing antibodies
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.

Registry

clinicaltrials.gov

Start Date

September 19, 2020

End Date

June 17, 2022

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 the "\*" option is not met during screening, the visit can be rescheduled)
•Chinese women aged 16-26 who can provide legal identification(If the subject is under 18 years old, proof of legal guardian's identity is also required);
•The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16-18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together
•Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
•When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.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 including the pill or condoms, etc ); 5.
•Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
•\*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;
•Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
•A 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 present with immune impairment or 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 other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);
•Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;
•Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;
•Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;
•A history or family history of convulsions, epilepsy, encephalopathy and mental illness;
•Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;

Outcomes

Primary Outcomes

The seroconversion rate of neutralizing antibodies

Time Frame: 30 days after the last dose

The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

Secondary Outcomes

Number of SAE within 7days after each dose(day 0 to day 7 after each dose)
Number of all SAE during the study period(Day 0 to 6 months post vaccination 3)
The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination(30 days after the last dose)
Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination(30 days after the last dose)
Number of AE within 30 minutes after each dose(30 mins after each dose)
Number of unsolicited adverse events within 30days after each dose(day 0 to day 30 after each dose)
Number and rate of pregnancy events(Day 0 to 6 months post vaccination 3)
Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects(30 days after the last dose)