Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity

November 16, 2023 updated by: Fujian Maternity and Child Health Hospital

Two Domestic HPV Vaccines (Wozehui ® and Cecolin ®) and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity：A Multi-center Cohort Study in China

This is a multi-center, open, prospective cohort study that aims to investigate the immunogenicity and immune persistence of two different domestically produced bivalent HPV vaccines compared with an imported HPV vaccine in women aged 13-14 years. A total of 3,000 subjects who have completed 2 doses of the domestic bivalent HPV vaccine and 3 doses of the imported HPV vaccine will be recruited from Fujian Maternal and Child Health Hospital as the initiator of the study, and will be recruited from a number of healthcare institutions nationwide. Of these, 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Wozehui), 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Cecolin), and 1,000 subjects were vaccinated with the imported HPV vaccine. Each subject was enrolled within 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and a total of two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. In response to the WHO Cervical Cancer Elimination Strategy, domestic bivalent HPV vaccine has been offered free of charge to adolescent females aged 13-14 years, but there is still a lack of evidence comparing the antibody titer levels of domestic HPV vaccine and imported HPV vaccine in younger females. Therefore, we conducted the present immunogenicity study to explore the immunogenicity and immune persistence after vaccination with domestic bivalent HPV vaccine versus imported HPV vaccine in this age group of females.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aims to: 1) Evaluate the immunogenicity of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 years old; 2) Evaluate the immune persistence of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 years old. This study is a multi-center, open, prospective cohort study with a total of 3,000 subjects recruited. According to the HPV vaccine that the participants received in the previous period, they were divided into 1,000 people in the domestic bivalent HPV vaccine group (Wozehui), 1,000 people in the domestic bivalent HPV vaccine group (Cecolin), and 1,000 people in the imported HPV vaccine group. Three immuneogenic blood was collected in all subjects 30-60 days, 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of either the domestic bivalent HPV vaccine or the imported HPV vaccine, which was used to perform HPV type 16 and 18 neutralizing antibody testing. The aim of this study was to evaluate the immunogenicity difference between two different domestically produced bivalent HPV vaccines and imported HPV vaccines in adolescent females aged 13-14 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Maternity and Child Health Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adolescent females between the ages of 13-14 years old at the time of the first dose of HPV vaccination who have completed their last dose of domestic bivalent HPV vaccine or imported HPV vaccine.

Description

Inclusion Criteria:

  • Participants who have completed all procedures of domestic bivalent HPV vaccine or imported HPV vaccine and are 30-60 days from the last dose of vaccination at the time of enrollment;
  • The participants are between 13-14 years old at the time of the first dose of domestic or imported HPV vaccination;
  • The participant himself/herself and his/her guardian are able to provide proof of legal identity;
  • The participant and his/her guardian are capable of understanding and signing the informed consent form;
  • Participants are willing to complete study-related follow-up visits and blood collection as required by the protocol.

Exclusion Criteria:

  • Participants who have received other marketed HPV vaccines, or who have participated in clinical studies of HPV vaccines, or who have participated in clinical studies of other vaccines within the last 6 months;
  • Participants with congenital malformations, developmental disorders, genetic defects, and severe malnutrition that are severe or cause damage to vital organs;
  • Participants with a history of epilepsy, psychosis, and major depression requiring medication, convulsions or seizures or a family history of psychosis;
  • Participants who are immune compromised or have been diagnosed with congenital or acquired immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Rheumatoid - - Arthritis, Juvenile Rheumatoid Arthritis (JRA), Inflammatory Bowel Disease (IBD), or other autoimmune disease, subjects who have received immunosuppressive therapy within the past 6 months;
  • Absence of spleen, functional absence of spleen, and subjects with any condition resulting in absence of spleen or splenectomy;
  • Subjects with physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
  • Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in a clinical trials.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adolescent females who received their first dose of HPV vaccine at 13-14 years
Adolescent females who completed their last dose of domestic bivalent HPV vaccine or imported HPV vaccine and were between 13 and 14 years of age at the time of the first dose. Two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of vaccination.
Other: Follow up
Each subject was recruited in 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and followed up at 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, with a total of two follow-up visits. At enrollment and both follow-up visits, subjects were required to collect 2 tubes of peripheral venous blood each.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The neutralization antibody GMT and antibody positivity testing at baseline
Time Frame: Baseline
The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested
Baseline
The neutralization antibody GMT and antibody positivity testing at 12-mouth follow-up
Time Frame: 12-month follow-up
The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 12 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine.
12-month follow-up
The neutralization antibody GMT and antibody positivity testing at baseline 36-mouth follow-up
Time Frame: 36-month follow-up
The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 36 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine.
36-month follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Maternity and Child Health Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pengming Sun, Fujian Maternal and Child Health Hospital

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HVAC2303

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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