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

PHASE4CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

January 31, 2008

Study Completion Date

June 30, 2009

Conditions
HIV InfectionHepatitis 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."

Trial Locations (11)

2013

Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital, Johannesburg

7505

Tygerberg Hospital, Bellville

20010

Children's Hosp Natinal Med Center, Washington D.C.

70112

Tulane Med Center, New Orleans

90054

Childrens Hosp of Los Angeles, Los Angeles

94118

University of California at San Francisco, San Francisco

21941590

Ippmg-Ufrj, Rio de Janeiro

30130-100

Federal University of Minas Gerais, Belo Horizonte

14049-900

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP, Ribeirão Preto

01246-900

Instituto de Infectologia Emilio Ribas, São Paulo

20221-903

Hospital dos Sevidores do Estado, Rio de Janeiro

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT00106964 - Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth | Biotech Hunter | Biotech Hunter