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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04704908

Enrollment

979

Registered

2021-01-12

Start date

2021-02-06

Completion date

2023-12-31

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Human Papilloma Virus 16, Human Papilloma Virus 18, adolescent girl, non-inferiority, immuno-persistence

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

Interventions

DRUGRecombinant 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 32 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026