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

NCT ID: NCT04704908

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 979 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-06
• Study Completion Date: 2023-12-31

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

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

9-17y (0,1,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Intervention Type: DRUG

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

9-14y (0,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Intervention Type: DRUG

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

18-26y (0,1,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Intervention Type: DRUG

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant

Intervention Type: DRUG

Other Intervention Names

There is no other Intervention in this study

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jun Zhang

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ting Wu, Ph. D.

Role: STUDY_CHAIR

Xiamen University

Locations

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

HPV-PRO-006-3

Identifier Type: -

Identifier Source: org_study_id