Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)

Active, not recruiting

• Conditions: Cervical Cancer; Persistent Infection; Vulvar Intraepithelial Neoplasia; Vaginal Intraepithelial Neoplasia; Cervical Intraepithelial Neoplasia
• Interventions: Drug: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

• Registration Number: NCT04704908
• Lead Sponsor: Jun Zhang

Brief Summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Detailed Description

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .The investigators will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 54 months after dose 1

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-12
• Study Start: 2021-02-06
• Primary Completion: 2021-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 979

Inclusion Criteria

1. Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose;
2. Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
3. Able to comply with the requests of the study;

Exclusion Criteria

1. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
3. Abnormal blood clotting function or coagulopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
9-17y (0,1,6m)	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)	Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
9-14y (0,6m)	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)	Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
18-26y (0,1,6m)	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)	Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Primary Outcome Measures

Name	Time	Method
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type-specific IgG antibody)	Month 54	To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level on 54 month after the dose 1

Secondary Outcome Measures

Name	Time	Method
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type specific neutralizing antibody)	Month 54	To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 54 month after the dose 1

Trial Locations

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China