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

Sponsor

Jun Zhang (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04704908

Collaborator

Xiamen Innovax Biotech Co., Ltd (Industry), Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (Industry)

979

Enrollment

Location

21.8

Anticipated Duration (Months)

44.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia Cervical Cancer Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia Persistent Infection	Drug: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

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 Design

Study Type:

Observational

Anticipated Enrollment :

979 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 6, 2021

Actual Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	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 Other Names: There is no other Intervention in this study
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	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 Other Names: There is no other Intervention in this study
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	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 Other Names: There is no other Intervention in this study

Arm

Intervention/Treatment

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

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

Other Names:

There is no other Intervention in this study

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

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

Other Names:

There is no other Intervention in this study

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

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

Other Names:

There is no other Intervention in this study

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 32 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

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;
Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
Able to comply with the requests of the study;

Exclusion Criteria:

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 ;
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;
Abnormal blood clotting function or coagulopathy