NCT00106964|CompletedPhase 4ResultsDMC
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth
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Sponsor study identifier
interventional
371
3 countries
11
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
June 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2005
Actual (reported)April 4, 2005
Actual (reported)January 2008
Actual (reported)June 2009
Actual (reported)June 28, 2013
Actual (reported)Sero-response to Hepatitis B Surface Antigen
The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Week 28
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
Baseline through Week 72
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED
Baseline through Week 72
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY
Baseline through Week 72
Response Rates in HIV+ Youth Within Each Study Arm by Study Duration
Entry through Week 72
Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM
Week 28
Standard dose (20 mcg) of Hepatitis B vaccine.
40 mcg of Hepatitis B vaccine
20 mgc of Twinrix
A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
Childrens Hosp of Los Angeles
Los Angeles, California, 90054, United States
University of California at San Francisco
San Francisco, California, 94118, United States
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, 20010, United States
Tulane Med Center
New Orleans, Louisiana, 70112, United States
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP
Ribeirão Preto, São Paulo, 14049-900, Brazil
Instituto de Infectologia Emilio Ribas
Flynn PM, Cunningham CK, Rudy B, Wilson CM, Kapogiannis B, Worrell C, Bethel J, Monte D, Bojan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. J Acquir Immune Defic Syndr. 2011 Apr;56(4):325-32. doi: 10.1097/QAI.0b013e318203e9f2.
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
371 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2005
First Posted
April 4, 2005
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml: A single dose of 1 mL will be administered in the deltoid muscle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
São Paulo, São Paulo, 01246-900, Brazil
Hospital dos Sevidores do Estado
Rio de Janeiro, 20221-903, Brazil
Ippmg-Ufrj
Rio de Janeiro, 21941590, Brazil
Tygerberg Hospital
Bellville, Cape Town, 7505, South Africa
Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital
Johannesburg, Gauteng, 2013, South Africa
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
Primary Completion
January 2008
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
March 29, 2017
Results First Posted
June 28, 2013
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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