Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children

June 17, 2020 updated by: Qiu Li, Children's Hospital of Chongqing Medical University
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis,and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis,and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to evaluate the existence of immune protection in healthy children with negative hepatitis B surface antibody and find a method to evaluate the immune protection induced by hepatitis B vaccine.

Study Overview

Status

Unknown

Conditions

Detailed Description

One method to determine the long-term protection provided by hepatitis B vaccine against HBV infection is to estimate the cumulative incidence of chronic carrier status and breakthrough infection of previously vaccinated individuals in different periods. Up to now, no international standard suggests that hepatitis B vaccine should be used as a routine immunization program. However, it is an important issue to discuss the immune protection of healthy children with negative hepatitis B surface antibody and the duration of this protection in the future. Therefore, this study aims to evaluate the existence of immune protection of healthy children with negative hepatitis B surface antibody, find a method to evaluate the immune protection induced by hepatitis B vaccine.

The main content of the study: To recruit healthy children. Children lacking HBsAb were selected for immune memory test and receive a Hep B booster. The results of Antibody positive group and antibody negative group were compared and analyzed. To find out the most suitable method for evaluating immune protection.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Children's Hospital of Chongqing Medical University

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

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Children Aged 1-15 in Chongqing

Description

Inclusion Criteria:

  • Children who are 1-15 years old in Chongqing
  • After birth, three injections of Hep B were inoculated in time according to the procedure of 0, 1 and 6 months(The vaccination certificate record)
  • No HBV booster vaccine given since primary HBV immunization
  • Children or guardian knew and agreed to accept the study
  • Follow - up study and blood collection after vaccination can be accepted

Exclusion Criteria:

  • Unwilling or impossible to participate in this research project;
  • Have a history of allergy or have had a serious vaccine reaction
  • Have immune impairment diseases and appear immune impairment;
  • Immunosuppressive treatment, receive any injection or oral administration of cortisone or cancer chemotherapy;
  • Any kind of vaccine or any kind of observation drug has been vaccinated in the past four weeks;
  • Any acute disease or other infection requiring antibiotic or antiviral treatment in the past four weeks;
  • Fever symptoms occurred in the past week ( axillary temperature ≥ 38 °C)
  • Blood transfusion experience;
  • Has a history of more serious infectious diseases ( five types of hepatitis, AIDS, syphilis, gonorrhea, etc. );
  • Hepatitis B infection or carriers(lineal relationship);
  • Abnormal physical examination

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
Time Frame
Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody
Time Frame: 1-month
1-month
Changes of humoral and cellular immune response after hepatitis B vaccine boosters
Time Frame: 1-month
1-month

Collaborators and Investigators

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

Sponsor

Children's Hospital of Chongqing Medical University

Investigators

  • Study Director: Yao Zhao, postdoctor, Chongqing Children's Hospital of Chongqing Medical University

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 (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-06

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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