Hepatitis B Vaccination (HBV) in HIV Infected Children
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Intradermal HBV 1 course Biological: Intramuscular HBV I course |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children |
- Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Number of adverse events in HBV ID group and HBV IM group [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
- Proportion of protective antiHBs in HIV children after protocol defining immune recovery [ Time Frame: 7 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
HBV ID
|
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 |
|
Active Comparator: 2
HBV IM
|
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 |
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| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Thailand | |
| HIV-NAT | |
| Bangkok, Thailand, 10330 | |
| Pediatric infectious diseases section, King Chulalongkorn Memorial hospital | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Torsak Bunupuradah, MD | The HIV Netherlands Australia Thailand Research Collaboration |
More Information
Additional Information:
No publications provided
| Responsible Party: | Torsak Bunupuradah, HIV-NAT, The Thai Red Cross AIDS Research Center |
| ClinicalTrials.gov Identifier: | NCT00886964 History of Changes |
| Other Study ID Numbers: | HIV-NAT 107 |
| Study First Received: | April 22, 2009 |
| Last Updated: | June 4, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
HBV vaccine HIV children immune recovery HBV antibody |
Intradermal Intramuscular antibody response after HBV vaccine treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 17, 2013