CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 371 enrolled
Drug / intervention
Engerix-B 20 mcg +2 morebiological
Likely dose
Engerix-B 20 mcg or 40 mcg, or Twinrix (20 mcg HBsAg + 720 EIA HAV Ag); administered intramuscularly at weeks 0, 4, and 24AI-extracted
Key inclusion· 4
  • ✓Documented HIV-positive status
  • ✓Age 12 to <25 years
  • ✓History of no or one hepatitis B vaccination
  • ✓Not pregnant; females must use approved birth control during vaccine phase
Key exclusion· 10
  • ✕History of more than one hepatitis B vaccination
  • ✕Serologic evidence of past or present hepatitis B infection (anti-HBsAg, HBsAg, or anti-HBcAg positive)
  • ✕Previous allergic reaction to hepatitis A or B vaccine or vaccine components (yeast, thimerosal, aluminum)
  • ✕Active opportunistic infection or current treatment for known or suspected serious bacterial infection at pre-entry

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

Search/NCT00106964
NCT00106964Phase 4Completed
CompareCT.gov

A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

University of North Carolina, Chapel Hill·interventional·Posted Apr 4, 2005·Updated Mar 29, 2017

In Brief

A Phase 4 clinical trial evaluating Engerix-B 20 mcg, Engerix-B 40 mcg, and 1 other intervention for HIV Infection and Hepatitis B. Completed, enrolled 371 participants across 11 sites in 3 countries.

Detailed Summary

Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, Hepatitis B
CountriesBrazil, South Africa, United States
CollaboratorsNational Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 4, 2005
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 21.2 years ago

Interventions

Engerix-B 20 mcgbiological

A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.

Engerix-B 40 mcgbiological

A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.

Twinrix 720 EIA HAV Ag plus 20 mcg HBsAgbiological

Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml: A single dose of 1 mL will be administered in the deltoid muscle.