Hepatitis B Vaccination (HBV) in HIV Infected Children
Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children
1 other identifier
interventional
80
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Apr 2009
Shorter than P25 for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 17, 2020
July 1, 2020
1.1 years
April 22, 2009
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM
8 weeks
Secondary Outcomes (3)
Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV
4 weeks
Number of adverse events in HBV ID group and HBV IM group
7 months
Proportion of protective antiHBs in HIV children after protocol defining immune recovery
7 months
Study Arms (2)
1
ACTIVE COMPARATORHBV ID
2
ACTIVE COMPARATORHBV IM
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active AIDS
- Active opportunistic infection
- Platelet \< 50,000/ mm3 at screening visit
- History of hypersensitivity to HBV vaccine
- Using oral steroid or immunosuppressive drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
HIV-NAT
Bangkok, 10330, Thailand
Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
Bangkok, 10330, Thailand
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torsak Bunupuradah, MD
The HIV Netherlands Australia Thailand Research Collaboration
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 17, 2020
Record last verified: 2020-07