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OpenTrials
Completed

NCT Number: NCT00476411

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIV-NAT Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBV vaccine

Biological

HBV vaccine 3 doses at month 0, 1, and 6

Primary outcomes

  1. 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 outcomes

  1. antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups

    Time frame: 1 year

  2. liver function test after HAART in HIV patients compare between negative and positive HBV DNA

    Time frame: 1 year

  3. 3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
May 22, 2007
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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