Loading clinical trials...
Loading clinical trials...
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.
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.
Age
1 - 15 years
Sex
ALL
Healthy Volunteers
Yes
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Start Date
July 9, 2021
Primary Completion Date
September 9, 2021
Completion Date
December 31, 2025
Last Updated
March 10, 2022
80
ESTIMATED participants
hepatitis B vaccine(HepB)
BIOLOGICAL
Lead Sponsor
Children's Hospital of Chongqing Medical University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions