Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing

NCT ID: NCT03867643

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-09
• Study Completion Date: 2025-12-31

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 carry out a comprehensive study to evaluate the efficacy of hepatitis B vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in Chongqing.

Detailed Description

Hepatitis B virus (HBV) infection is a major public health problem around the world. More than 2 billion people have been infected with HBV. Although the World Health Organization (WHO) has incorporated hepatitis B vaccination into routine immunization programs for infants and adolescents since 1986 to reduce the incidence of chronic liver diseases, liver cirrhosis and hepatocellular carcinoma associated with hepatitis B virus, there are still more than 400 million chronic carriers. Although it is currently recognized that the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine, the protective effect of the neonatally vaccinated children weakened as time goes on, which involves the question of the need of boosters. However, there are still some problems concerning hepatitis B vaccine boosters for healthy children. In China, there has not been a standardized directory to guide hepatitis B vaccine booster. Scholars have great controversy on the necessity, age, dosage and other aspects of hepatitis B vaccine booster. Researchers conducted an investigation on the Anti-HBs level of 93,326 Chinese children aged 1 - 16 who completed basic immunization. The results showed that the proportion of HBsAb positive in children aged 1 - 8 years old decreased dramatically, with 8 - year - old children having the lowest proportion of protective antibody. Therefore, this study is intended to explore the protective effect of hepatitis B vaccine on the body and the effect of multiple vaccines. This study will recruit some healthy children with anti-HBs at a low level (titer <10mIU/mL and [10,100) mIU/mL) in Chongqing and conduct selective re-vaccination according to the results of the first detection of hepatitis B surface markers in healthy children. According to the changes of immune status after booster, the efficacy of hepatitis B vaccine boosters was comprehensively evaluated.

Conditions

Hepatitis B Vaccine Adverse Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatitis B vaccine booster

Children with anti-HBs at a level of\<10mIU/mL or \[10,100) mIU/mL before booster.

hepatitis B vaccine(HepB)

Intervention Type: BIOLOGICAL

Children with anti-HBs at a low level (\<10mIU/mL and \[10,100) mIU/mL) were received a dose of hepatitis B vaccine booster after informed consent.

Observation

Children with anti-HBs at a level of \>100mIU/mL or \[10,100) mIU/mL before booster.

No interventions assigned to this group

Interventions

hepatitis B vaccine(HepB)

Children with anti-HBs at a low level (\<10mIU/mL and \[10,100) mIU/mL) were received a dose of hepatitis B vaccine booster after informed consent.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Born after Jan. 1st, 2005 in Chongqing, China;

2. Completion of the full primary immunization of HepB after birth;

3. No HBV booster vaccine history.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qiu Li

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao Zhao, postdoctor

Role: STUDY_DIRECTOR

Chongqing Children's Hospital of Chongqing Medical University

Locations

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Zhao, postdoctor

Role: CONTACT

Zhaoy@cqmu.edu.cn

86-23-6360-3083

Facility Contacts

Yao Zhao, postdoctor

Role: primary

Other Identifiers

2019-09

Identifier Type: -

Identifier Source: org_study_id