Hepatitis B Vaccination (HBV) in HIV Infected Children
Condition: HIV Infections
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 2

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Intradermal HBV 1 course; Intramuscular HBV I course
Intervention type(s): Biological; Biological
Intervention description(s): Dosage: 2 microgram (mcg), 0.1 ml per dose
Location: left deltoid area x 1 injection
Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months; Dosage: 2 microgram (mcg), 0.1 ml per dose
Location: left deltoid area x 1 injection
Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HBV vaccine; HIV children; immune recovery; HBV antibody; Intradermal; Intramuscular; antibody response after HBV vaccine; treatment experienced