A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection - Full Text View

Purpose

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.

Condition	Intervention
Hepatitis B Virus	Biological: HBV vaccine

MedlinePlus related topics:

AIDS Hepatitis Hepatitis B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
liver function test after HAART in HIV patients compare between negative and positive HBV DNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental HBV vaccine	Biological: HBV vaccine HBV vaccine 3 doses at month 0, 1, and 6

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476411

Locations


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

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration

Investigators


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

More Information

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

Responsible Party:	HIV-NAT ( Kiat Ruxrungtham )
Study ID Numbers:	HIV-NAT 036
First Received:	May 20, 2007
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00476411
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

isolated HBc

HBV vaccine response

occult HBV in isolated antiHBC compared HIV to non HIV

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

HIV Infections

Acquired Immunodeficiency Syndrome

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	The HIV Netherlands Australia Thailand Research Collaboration
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476411