drugset / Trial / NCT01289106

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

NCT01289106

Phase 3 Unknown 132 enrolled Chiang Mai University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2011-01
Primary completion
2011-10
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HepavaxGene Vaccine 20 ug Intramuscular
Subject HepavaxGene Vaccine 40 ug Intramuscular