The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

January 24, 2023 updated by: Jun Zhang

The Durability of Protection and Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years

The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study before and to evaluate the durability of protection and immuno-persistence of the bivalent HPV vaccine on 90m and 114m after dose 1.

Study Type

Observational

Enrollment (Anticipated)

1339

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 54 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

In Henan Province, participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose

Description

Inclusion Criteria:

  1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
  2. Participants 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 used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
  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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccine group
Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.
Biological: 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
Control group
Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
Time Frame: expected 2-3 years
To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
expected 2-3 years
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1
Time Frame: expected 2-3 years
To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects
expected 2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HPV16 and anti-HPV18 type-specific IgG antibody level on 90m and 114m after dose 1
Time Frame: expected 2-3 years
To detect the anti-HPV 16 and anti-HPV 18 seroconversion rates and geometric mean concentrations on 90m and 114m after dose 1
expected 2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Zhang

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Anticipated)

August 10, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-PRO-003-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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