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

Primary Purpose

Hepatitis b Virus

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
HBV vaccine
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis b Virus focused on measuring isolated HBc, HBV vaccine response, occult HBV in isolated antiHBC compared HIV to non HIV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HIV-NAT Thai Red Cross AIDS Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

HBV vaccine

Outcomes

Primary Outcome Measures

HBV DNA in HIV-infected patients presenting with a serological pattern of isolated anti-HBcAg compare to non HIV patients with isolated antiHBc

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2007
Last Updated
July 15, 2020
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
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1. Study Identification

Unique Protocol Identification Number
NCT00476411
Brief Title
A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis b Virus
Keywords
isolated HBc, HBV vaccine response, occult HBV in isolated antiHBC compared HIV to non HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HBV vaccine
Intervention Type
Biological
Intervention Name(s)
HBV vaccine
Intervention Description
HBV vaccine 3 doses at month 0, 1, and 6
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups
Time Frame
1 year
Title
liver function test after HAART in HIV patients compare between negative and positive HBV DNA
Time Frame
1 year
Title
3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anchalee Avihingsanon, MD
Organizational Affiliation
HIV-NAT, Thai Red Cross AIDS Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV-NAT Thai Red Cross AIDS Research Center
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.hivnat.org
Description
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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

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