A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection

July 15, 2020 updated by: The HIV Netherlands Australia Thailand Research Collaboration

The Efficacy of HBV Vaccine Response and Prevalence of Occult HBV Infection in Isolated Anti HBc Between HIV Infected and HIV Un-infected Thai Patients

The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the main route of transmission which is different from developed countries. Therefore, isolated antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality might be reduced. The prevalence and clinical importance of isolated antiHBc in Thai have not been investigated yet. There is also limited data of HBV vaccine response in this setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of the Hepatitis B core antigen (anti-HBc)in the Thai population is about 70 %. No data of isolated anti-HBc is reported. Anti-HBc antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. The prevalence of isolated antiHBc antigen is expected to be higher in endemic areas of HBV infection. There is conflicting data of occult HBV infection in HIV-infected patients. In Thailand, perinatal transmission is the main route of HBV transmission, different from developed countries. Therefore, isolated anti-HBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. HBV genotype C is correlated with more cirrhosis and hepatoma than genotype B. A study from Taiwan demonstrated that HBV DNA > 100,000 copies/ml is correlated with cirrhosis and hepatoma. Sustained reduction of HBV replication lowers the risk of hepatoma in HBV related cirrhosis. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality will be reduced.

The prevalence and its clinical importance of isolated anti-HBc in the Thai population has not been investigated yet. There is also limited data of HBV vaccine response in this setting.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • HIV-NAT Thai Red Cross AIDS Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-infected adults followed at HIV-NAT and HIV-NAT affiliated hospitals and Un-infected HIV adults followed at chulalongkorn hospital and blood bank
  • AntiHBc positive without HBsAg and antiHBs
  • Written inform consent

Exclusion Criteria:

  • Patients receiving, or with an anticipated need to receive, any concomitant medications with the potential to decrease the response to HBV vaccine such as long term steroid user, chemotherapy, cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
HBV vaccine
Biological: HBV vaccine
HBV vaccine 3 doses at month 0, 1, and 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBV DNA in HIV-infected patients presenting with a serological pattern of isolated anti-HBcAg compare to non HIV patients with isolated antiHBc
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups
Time Frame: 1 year
1 year
liver function test after HAART in HIV patients compare between negative and positive HBV DNA
Time Frame: 1 year
1 year
3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Investigators

  • Principal Investigator: Anchalee Avihingsanon, MD, HIV-NAT, Thai Red Cross AIDS Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 20, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe