HIV Infections Clinical Trial
Official title:
Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children
The purpose of this study is :
- To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and
intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly
active antiretroviral therapy (HAART)
- To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab
Hepatitis B virus (HBV) and HIV share the same route of transmission and can have
co-infection. The prevalence of this co-infection was 8.7% in Thai adult[1, 2] and 12.1% in
African HIV vertically transmitted children[3]. Occurrence of HBV has effects to treatment
due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti
HIV medication. HBV can cause chronic liver disease, cirrhosis and hepatocellular carcinoma.
In Thailand, the routine HBV vaccination program was started since 1992. Few reports in
severe immune compromise HIV children has been shown to lose their expected preventive
measles and hepatitis B antibody from history of scheduled vaccination even after the immune
recovery by HAART[4, 5]. Limited data in of prevalence of protective hepatitis B antibody
response after immune recovery in Thai HIV infected children treated with highly active
antiretroviral therapy. In addition, HBV revaccination in this group of children should be
considered[6].
The response of HBV revaccination intramuscularly (IM) at 0, 2 and 6 months in 63 HIV
children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively[6].
Protective anti-HBs were shown in the majority of non-responders to IM HBV vaccine health
care workers [21/23 (91.3%)] by two doses of intradermal route (ID)[7].
We hypothesize to see the faster and higher response of antiHBs after first dose of ID
compare to IM in anti HBsAb negative HIV infected children. No randomized control trial
compare antibody response between IM and ID route in HIV children after immune recovery. The
benefit from this trial would be decreased the vaccine cost for resourced limited country.
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