CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 800 target
Drug / intervention
HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/mlbiological
Likely dose
HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00230061
NCT00230061Phase 4Completed
CompareCT.gov

Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.

Erasmus Medical Center·interventional·Posted Sep 30, 2005·Updated Jun 2, 2010

In Brief

A Phase 4 clinical trial evaluating HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml for HIV Infections and Hepatitis B. Completed, enrolled 800 participants across 1 site.

Detailed Summary

In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Hepatitis B
CountriesNetherlands
CollaboratorsStichting Nuts Ohra

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartApr 1, 2004
Primary CompletionMay 1, 2008
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/mlbiological