Hepatitis B Vaccination (HBV) in HIV Infected Children

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886964
• Other study ID #: HIV-NAT 107
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B
• HIV Infections

Intervention

Biological:
• 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
• 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

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok
Thailand	Pediatric infectious diseases section, King Chulalongkorn Memorial hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	ART AIDS Charity Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM		8 weeks
Secondary	Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV		4 weeks
Secondary	Number of adverse events in HBV ID group and HBV IM group		7 months
Secondary	Proportion of protective antiHBs in HIV children after protocol defining immune recovery		7 months

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)