Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

Recruiting

• Conditions: Genital Wart; CIN1; CIN2; Cervical Cancer Stage IIa; Vaginal Cancer; CIN3; HPV Infections

• Registration Number: NCT05371353
• Lead Sponsor: Shanghai Bovax Biotechnology Co., Ltd.

Brief Summary

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Study Start: 2022-05-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
• The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
• The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
• Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion Criteria

• Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
• Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
• According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GMTs for Each of the HPV Types Contained in the Vaccine	Month 60	The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
SCR for Each of the HPV Types Contained in the Vaccine	Month 60	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine	Month 12	The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine	Month 12	The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

Trial Locations

Locations (2)

Yangchun Center For Disease Prevention And Control; 🇨🇳 Yangchun, Guangdong, China

Center for Disease Control and Prevention; 🇨🇳 Mianyang, Sichuan, China