Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents

NCT ID: NCT03864263

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2023-12-31

Brief Summary

Hepatitis B virus (HBV) infection is a major public health problem facing the world, with more than 2 billion people infected with HBV. There are more than 400 million chronic carriers, and 75% of carriers live in the Asia Pacific region.

The mother-to-child transmission route of hepatitis B virus is recognized as one of the most important routes of transmission, and recent studies have found that fathers who are carriers of HBV may also be one of the risk factors for HBV infection in children, but as far as the investigators know. Therefore, as a high-population area in China, the purpose of this study is to investigate the prevalence of HBV infection in this population.

Detailed Description

Hepatitis B virus (HBV) infection is a major public health problem facing the world, with more than 2 billion people infected with HBV. Although since 1986 the World Health Organization (WHO has reduced the incidence of hepatitis B virus-related chronic liver disease, cirrhosis and hepatocellular carcinoma by incorporating hepatitis B vaccination into routine vaccination programmes for infants and adolescents, There are more than 400 million chronic carriers, and 75% of carriers live in the Asia Pacific region. Occult hepatitis B virus infection (OBI) is HBV surface antigen negative, but HBV DNA can be detected by PCR. Although the clinical consequences of OBI have not yet been fully determined, recent studies have shown that OBI may cause HBV-related diseases such as hepatitis B, cirrhosis, hepatocellular carcinoma, or aggravation or aggravation, and patients who receive immunosuppression through organ or blood transfusion. OBI reactivation has occurred. The protective effect on humans after vaccination with hepatitis B vaccine has the investigator sakened over time, and anti-HBs-negative children may have a higher risk of HBV infection due to loss of protection.

The mother-to-child transmission route of hepatitis B virus is recognized as one of the most important routes of transmission, and recent studies have found that fathers who are carriers of HBV may also be one of the risk factors for HBV infection in children, but as far as the investigators know, only Studies in Taiwan and other places have reported studies on HBV infection in children with HBV-infected mothers, and no research has focused on the effects of fathers' HBV positivity on children. Therefore, as a high-population area in China, the purpose of this study is to investigate the prevalence of HBV infection in this population.

Conditions

Hepatitis b Virus Infection

Study Design

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

Study Groups

Children with HBsAg-positive patients

Children from a father or mother who are infected with HBV

Intervention Type: OTHER

Children without a family history of HBV

Children without a family history of HBV infection

Intervention Type: OTHER

Interventions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The father or (and) mother is HBV-infected (pre-pregnancy or present)；
• Children is vaccinated with hepatitis B vaccine after birth;

Exclusion Criteria

• Children with HBV infection;
• Participants agreed to undergo clinical follow-up studies.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qiu Li

OTHER

Sponsor Role: lead

Responsible Party

Qiu Li

Children's Hospital of Chongqing Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yao Zhao

Role: PRINCIPAL_INVESTIGATOR

Chongqing Children's Hospital of Chongqing Medical University

Locations

Chongqing Children's Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Zhao

Role: CONTACT

Zhaoy@cqmu.edu.cn

+862363603083

Facility Contacts

Yao Zhao

Role: primary

+862363603083

Other Identifiers

2019-30

Identifier Type: -

Identifier Source: org_study_id