Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth

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.

Conditions

• HIV Infection
• Hepatitis B

Interventions

BIOLOGICAL

Engerix-B 20 mcg

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

BIOLOGICAL

Engerix-B 40 mcg

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

BIOLOGICAL

Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Patricia Flynn, MD · St. Jude Children's Research Hospital

• Patricia Emmanuel, MD · University of South Florida, Peds. Div. of Infectious Disease

• Diane M. Straub, MD · University of South Florida, Peds. Div. of Infectious Disease

• Jorge Lujuan-Ziberman, MD · University of South Florida, Peds. Div. of Infectious Disease

• Lawrence D'Angelo, MD · Children's National Medical Center, Div. of Aldol & Young Adult Medicine

• Carleen Townsend-Akpan, CPNP · Children's National Medical Center, Div. of Aldol & Young Adult Medicine

• Jaime Martinez, MD · John H. Stroger Jr. Hospital

• Lisa Henry- Reid, MD · John H. Stroger Jr. Hospital

• Irma Febo, MD · University Pediatric Hospital

• LLeana Blasini, MD · University Pediatric Hospital

• Donna Futterman, MD · Montefiore Medical Center

• Marina Catallozzi, MD · Montifiore Medical Center

• Linda Levin, MD · Icahn School of Medicine at Mount Sinai

• Barbara Moscicki, MD · Univ. of California at San Franciso

• Coco Auerswald, MD · Univ. of California at San Franciso

• Sue Ellen Abdalian, MD · Tulane Medical Center

• Ligia Peralta, MD · University of Maryland

• Lawrence Friedman, MD · University of Miami

• Ana Puga, MD · Children's Diagnostic & Treatment Center

• Stephen Spector, MD · University of California, San Diego

• Rolando M Viani, MD · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2008-01-31

Completion

2009-06-30

Countries

• United States
• Brazil
• South Africa

Study Locations