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

NCT00106964 | Completed Phase 4 Results DMC

• 1 other identifier: ATN 024
• Study Type: interventional
• Target: 371
• Locations: 3 countries
• Sites: 11

Brief 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

Keywords

Hepatitis B vaccines; HIV-infected adolescents; Hepatitis B infection (negative)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Standard dose (20 mcg) of Hepatitis B vaccine.

Biological: Engerix-B 20 mcg

2

ACTIVE COMPARATOR

40 mcg of Hepatitis B vaccine

Biological: Engerix-B 40 mcg

3

ACTIVE COMPARATOR

20 mgc of Twinrix

Biological: Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg

Interventions

Engerix-B 20 mcg BIOLOGICAL

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

1

Engerix-B 40 mcg BIOLOGICAL

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

2

Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg BIOLOGICAL

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

3

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Documented HIV+
• Age 12 to \< 25 years
• History of no or one hepatitis B vaccination
• Not pregnant.
• Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.

You may not qualify if:

• History of \> 1 hepatitis B vaccination
• Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg)
• Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum.
• Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
• Presence of any known grade \>= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
• Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
• Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
• Receipt of immune globulin product or plasma product within 6 months preceding randomization
• Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
• Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization.
• Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (11)

Childrens Hosp of Los Angeles

Los Angeles, California, 90054, United States

Location

University of California at San Francisco

San Francisco, California, 94118, United States

Location

Children's Hosp Natinal Med Center

Washington D.C., District of Columbia, 20010, United States

Location

Tulane Med Center

New Orleans, Louisiana, 70112, United States

Location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Instituto de Infectologia Emilio Ribas

São Paulo, São Paulo, 01246-900, Brazil

Location

Hospital dos Sevidores do Estado

Rio de Janeiro, 20221-903, Brazil

Location

Ippmg-Ufrj

Rio de Janeiro, 21941590, Brazil

Location

Tygerberg Hospital

Bellville, Cape Town, 7505, South Africa

Location

Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital

Johannesburg, Gauteng, 2013, South Africa

Location

Related Publications (1)

• 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.

  PMID: 21350366 RESULT

Related Links

• Website for the Adolescent Trials Network for HIV/AIDS Interventions

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Interventions

Engerix-B; Hepatitis B Surface Antigens

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Results Point of Contact

• Title: Dr. Bob Harris
• Organization: Westat

bobharris@westat.com

301-251-1500

Study Officials

• Patricia Flynn, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

• Patricia Emmanuel, MD

  University of South Florida, Peds. Div. of Infectious Disease

  PRINCIPAL INVESTIGATOR

• Diane M. Straub, MD

  University of South Florida, Peds. Div. of Infectious Disease

  PRINCIPAL INVESTIGATOR

• Jorge Lujuan-Ziberman, MD

  University of South Florida, Peds. Div. of Infectious Disease

  PRINCIPAL INVESTIGATOR

• Lawrence D'Angelo, MD

  Children's National Medical Center, Div. of Aldol & Young Adult Medicine

  PRINCIPAL INVESTIGATOR

• Carleen Townsend-Akpan, CPNP

  Children's National Medical Center, Div. of Aldol & Young Adult Medicine

  PRINCIPAL INVESTIGATOR

• Jaime Martinez, MD

  John H. Stroger Jr. Hospital

  PRINCIPAL INVESTIGATOR

• Lisa Henry- Reid, MD

  John H. Stroger Jr. Hospital

  PRINCIPAL INVESTIGATOR

• Irma Febo, MD

  University Pediatric Hospital

  PRINCIPAL INVESTIGATOR

• LLeana Blasini, MD

  University Pediatric Hospital

  PRINCIPAL INVESTIGATOR

• Donna Futterman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Marina Catallozzi, MD

  Montifiore Medical Center

  PRINCIPAL INVESTIGATOR

• Linda Levin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Barbara Moscicki, MD

  Univ. of California at San Franciso

  PRINCIPAL INVESTIGATOR

• Coco Auerswald, MD

  Univ. of California at San Franciso

  PRINCIPAL INVESTIGATOR

• Sue Ellen Abdalian, MD

  Tulane Medical Center

  PRINCIPAL INVESTIGATOR

• Ligia Peralta, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Lawrence Friedman, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Ana Puga, MD

  Children's Diagnostic & Treatment Center

  PRINCIPAL INVESTIGATOR

• Stephen Spector, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Rolando M Viani, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2005
• First Posted: April 4, 2005
• Study Start: January 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2009
• Last Updated: March 29, 2017
• Results First Posted: June 28, 2013

Record last verified: 2016-02

Locations

ZA (2); BR (5); US (4)