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Completed

NCT Number: NCT00886964

Hepatitis B Vaccination (HBV) in HIV Infected 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

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HIV-NAT, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intradermal HBV 1 course

Biological

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

Intramuscular HBV I course

Biological

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

Primary outcomes

  1. Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM

    Time frame: 8 weeks

Secondary outcomes

  1. Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV

    Time frame: 4 weeks

  2. Number of adverse events in HBV ID group and HBV IM group

    Time frame: 7 months

  3. Proportion of protective antiHBs in HIV children after protocol defining immune recovery

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • ART AIDS Charity Fund

Registry information

Official study title

Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2009
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.

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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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