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Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects

NCT01289106 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2011-02-03

No results posted yet for this study

Summary

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

Hepavax-Gene

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

BIOLOGICAL

Hepavax-Gene

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

BIOLOGICAL

Hepavax-Gene

40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Kanokporn Chaiklang, MD · Faculty of Medicine, Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-10-31
Completion
2012-04-30

Countries

  • Thailand

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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 NCT01289106 on ClinicalTrials.gov