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

NCT04439435 | Unknown

• 1 other identifier: 2020-06
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (2)

• Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody

  1-month

• Changes of humoral and cellular immune response after hepatitis B vaccine boosters

  1-month

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Children Aged 1-15 in Chongqing

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Study Sites (1)

Chongqing Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Study Officials

• YAO ZHAO, postdoctor

  Chongqing Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

YAO ZHAO, postdoctor

CONTACT

86-23-6360-3083; Zhaoy@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

CN (1)