Hepatitis B Vaccination (HBV) in HIV Infected Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

HBV ID

Group Type ACTIVE_COMPARATOR

Intradermal HBV 1 course

Intervention Type 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

2

HBV IM

Group Type ACTIVE_COMPARATOR

Intramuscular HBV I course

Intervention Type 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

Interventions

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Intradermal HBV 1 course

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

Intervention Type BIOLOGICAL

Intramuscular HBV I course

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No