Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

April 15, 2024 updated by: Shanghai Bovax Biotechnology Co., Ltd.

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

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
    • Guangdong
      • Yangchun, Guangdong, China
        • Recruiting
        • Yangchun Center For Disease Prevention And Control
        • Contact:
    • Sichuan
      • Mianyang, Sichuan, China
        • Recruiting
        • Center for Disease Control and Prevention
        • 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

9 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects aged 9-45 years old have completed receiving three doses of quadrivalent HPV vaccine and provided blood sample at month 7

Description

Inclusion Criteria:

  • Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
  • The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
  • The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
  • Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion Criteria:

  • Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
  • Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
  • According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 12
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Month 12
SCR for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 24
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Month 24
SCR for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 36
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Month 36
SCR for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 48
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Month 48
SCR for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 60
The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18
Month 60
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 12
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
Month 12
GMTs for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 24
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
Month 24
GMTs for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 36
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
Month 36
GMTs for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 48
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
Month 48
GMTs for Each of the HPV Types Contained in the Vaccine
Time Frame: Month 60
The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7
Month 60

Collaborators and Investigators

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

Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Investigators

  • Study Director: Jikai Zhang, Guangdong Center for Disease Prevention and Control

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)

May 14, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-HPV-3003

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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