Clinical Trials

MainTitle

Hepatitis B Vaccination (HBV) in HIV Infected Children

This study has been completed
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

Collaborator
ART AIDS Charity Fund

Information provided by (Responsible Party)
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
History of Changes
Purpose

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)
vaccinate 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children

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 ]
Secondary Outcome Measures:
  • Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV [ Time Frame: 4 weeks ]
  • Number of adverse events in HBV ID group and HBV IM group [ Time Frame: 7 months ]
  • Proportion of protective antiHBs in HIV children after protocol defining immune recovery [ Time Frame: 7 months ]

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

Eligibility

Ages Eligible for Study: 1 Year to 18 Years  
Sexes Eligible for Study: All  
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

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

More Information

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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  

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
Hepatitis B
Antibodies

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.