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Hepatitis B Vaccination (HBV) in HIV Infected Children

NCT00886964 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-17

No results posted yet for this study

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

Conditions

  • HIV Infections

Interventions

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

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

Sponsors & Collaborators

  • ART AIDS Charity Fund

    collaborator UNKNOWN

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Torsak Bunupuradah, MD · The HIV Netherlands Australia Thailand Research Collaboration

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00886964 on ClinicalTrials.gov