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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B Vaccine Adverse Reaction
• Intervention / Treatment: Biological: hepatitis B vaccine(HepB)

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Yao Zhao, postdoctor; Phone Number: 86-23-6360-3083; Email: Zhaoy@cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Children's Hospital of Chongqing Medical University

Participation Criteria

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

1. History of allergy or adverse reaction of vaccine;
2. History of immunosuppressive treatment or immunodeficiency;
3. Any kind of vaccination in the past four weeks;
4. Any acute disease or anti-infective therapy in the past four weeks;
5. Fever history in the past one week (axillary temperature ≥ 38 ℃);
6. Blood transfusion history;
7. History of infectious diseases (hepatitis, AIDS, syphilis, gonorrhea, etc.);
8. The family history of HBV in three generations of lineal relatives;
9. Abnormal physical examination.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatitis B vaccine booster; Children with anti-HBs at a level of<10mIU/mL or [10,100) mIU/mL before booster.	Biological: 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.
Observation; Children with anti-HBs at a level of >100mIU/mL or [10,100) mIU/mL before booster.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBsAb positive rate	The proportion of HBsAb in children with and without hepatitis B vaccine boosters	3-year
HBsAg-specific T cell response	The proportion of HBsAg-specific IFN-γ-producing T cells in children with and without hepatitis B vaccine boosters	3-year
HBsAb protective efficacy	Evaluate the changes in the protective efficacy of HBsAb after hepatitis B vaccine booster	3-year

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (ACTUAL): July 9, 2021
• Primary Completion (ACTUAL): September 9, 2021
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Immune response; booster; Hepatitis B Vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: 2019-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No