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

Cervical Cancer Clinical Trial

Official title:

Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04704908
• Other study ID #: HPV-PRO-006-3
• Status: Active, not recruiting
• Start date: February 6, 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 979
• Est. completion date: December 2023
• Est. primary completion date: April 1, 2021
• Gender: Female
• Age group: 14 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Persistent Infection
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Jiangsu Provincial Centre for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Jun Zhang	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type-specific IgG antibody)	To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level on 54 month after the dose 1	Month 54
Secondary	Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type specific neutralizing antibody)	To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 54 month after the dose 1	Month 54