Trial record 19 of 33 for:    " April 22, 2009":" May 22, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Hepatitis B Vaccination (HBV) in HIV Infected Children

This study has been completed.
Sponsor:
Collaborator:
ART AIDS Charity Fund
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00886964
First received: April 22, 2009
Last updated: June 4, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886964

Locations
Thailand
HIV-NAT
Bangkok, Thailand, 10330
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
ART AIDS Charity Fund
Investigators
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 August 25, 2014