Clinical trial NCT00886964: Hepatitis B Vaccination (HBV) in HIV Infected Children
Official title: Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HBV vaccine
HIV children
immune recovery
HBV antibody
Intradermal
Intramuscular
antibody response after HBV vaccine
treatment experienced
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: ART AIDS Charity Fund
First posted: 2009-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* HIV infected individuals
* Age 1-18 years
* Current CD4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years
* Signed written informed consent
* Negative HBs Ag, antiHBs, and antiHBc at screening visit

Exclusion Criteria:

* Active AIDS
* Active opportunistic infection
* Platelet \< 50,000/ mm3 at screening visit
* History of hypersensitivity to HBV vaccine
* Using oral steroid or immunosuppressive drugs

Primary outcomes:
measure: Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV
timeFrame: 4 weeks
measure: Number of adverse events in HBV ID group and HBV IM group
timeFrame: 7 months
measure: Proportion of protective antiHBs in HIV children after protocol defining immune recovery
timeFrame: 7 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
city: Bangkok
country: Thailand
facility: Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Torsak Bunupuradah, MD
role: PRINCIPAL_INVESTIGATOR
References: