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

27. Februar 2017 aktualisiert von: University of North Carolina, Chapel Hill

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well documented in the literature. Given the importance of preventing hepatitis B virus (HBV) co-infection in HIV+ youth and the poor response rates in this population, this study will attempt to improve the immediate and long-term sero-response rates by undertaking a randomized, open-label trial of three hepatitis B vaccination schemas, as follows:

  1. standard adult dosing of HBV-only vaccine: Engerix-B 20 mcg at Entry, Week 4 and Week 24
  2. increased adult dosing of HBV-only vaccine: Engerix-B 40 mcg at Entry, Week 4 and Week 24
  3. standard adult dosing of combined HBV/hepatitis A virus (HAV) vaccine: Twinrix 720 enzyme immunoassay (EIA) HAV Ag plus 20 mcg HBsAg at Entry, Week 4 and Week 24.

This study will also describe the safety of administration of an increased dose of the hepatitis B vaccine in this population. In general, patients undergoing dialysis who have received the dosing regimen recommended for immunocompromised individuals have tolerated the vaccine series well.

Design: This is a stratified, block-randomized, open-label trial of three hepatitis B vaccination schemas in HIV-infected and HBV-uninfected youth. Once randomized, there will be a total of 6 study visits in a 72 week period. Vaccination will occur at Entry, Week 4 and Week 24. Primary sero-response will be evaluated at Week 28 and sustainability of response will be evaluated at Weeks 48 and 72 for those who achieve a primary antibody response of >= 10 IU/ml. Primary non-responders (antibody response of < 10 IU/ml) will be provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48 and evaluated for responsiveness at Week 72.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

371

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Brasilien
      • Rio de Janeiro, Brasilien, 20221-903
        • Hospital dos Sevidores do Estado
      • Rio de Janeiro, Brasilien, 21941590
        • Ippmg-Ufrj
    • MG
      • Belo Horizonte, MG, Brasilien, 30130-100
        • Federal University of Minas Gerais
    • SP
      • Ribeirao Preto, SP, Brasilien, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP
      • Sao Paulo, SP, Brasilien, 01246-900
        • Instituto de Infectologia Emilio Ribas
  • Südafrika
    • Cape Town
      • Bellville, Cape Town, Südafrika, 7505
        • Tygerberg Hospital
    • Gauteng
      • Johannesburg, Gauteng, Südafrika, 2013
        • Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90054
        • Childrens Hosp of Los Angeles
      • San Fransisco, California, Vereinigte Staaten, 94118
        • University of California at San Francisco
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • Children's Hosp Natinal Med Center
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • Tulane Med Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 1
Standard dose (20 mcg) of Hepatitis B vaccine.
Biologisch: 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.
Aktiver Komparator: 2
40 mcg of Hepatitis B vaccine
Biologisch: 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.
Aktiver Komparator: 3
20 mgc of Twinrix
Biologisch: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sero-response to Hepatitis B Surface Antigen
Zeitfenster: Week 28
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
Zeitfenster: Baseline through Week 72
The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.
Baseline through Week 72
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED
Zeitfenster: Baseline through Week 72
The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.
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
Zeitfenster: Baseline through Week 72
The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.
Baseline through Week 72
Response Rates in HIV+ Youth Within Each Study Arm by Study Duration
Zeitfenster: Entry through Week 72
Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.
Entry through Week 72
Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM
Zeitfenster: Week 28
Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of North Carolina, Chapel Hill

Mitarbeiter

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: Patricia Emmanuel, MD, University of South Florida, Peds. Div. of Infectious Disease
  • Hauptermittler: Diane M. Straub, MD, University of South Florida, Peds. Div. of Infectious Disease
  • Hauptermittler: Jorge Lujuan-Ziberman, MD, University of South Florida, Peds. Div. of Infectious Disease
  • Hauptermittler: Lawrence D'Angelo, MD, Children's National Medical Center, Div. of Aldol & Young Adult Medicine
  • Hauptermittler: Carleen Townsend-Akpan, CPNP, Children's National Medical Center, Div. of Aldol & Young Adult Medicine
  • Hauptermittler: Jaime Martinez, MD, John H. Stroger Jr. Hospital
  • Hauptermittler: Lisa Henry- Reid, MD, John H. Stroger Jr. Hospital
  • Hauptermittler: Irma Febo, MD, University Pediatric Hospital
  • Hauptermittler: LLeana Blasini, MD, University Pediatric Hospital
  • Hauptermittler: Donna Futterman, MD, Montefiore Medical Center
  • Hauptermittler: Marina Catallozzi, MD, Montifiore Medical Center
  • Hauptermittler: Linda Levin, MD, Icahn School of Medicine at Mount Sinai
  • Hauptermittler: Barbara Moscicki, MD, Univ. of California at San Franciso
  • Hauptermittler: Coco Auerswald, MD, Univ. of California at San Franciso
  • Hauptermittler: Sue Ellen Abdalian, MD, Tulane Medical Center
  • Hauptermittler: Ligia Peralta, MD, University of Maryland
  • Hauptermittler: Lawrence Friedman, MD, University of Miami
  • Hauptermittler: Ana Puga, MD, Children's Diagnostic & Treatment Center
  • Hauptermittler: Stephen Spector, MD, University of California, San Diego
  • Hauptermittler: Rolando M Viani, MD, University of California, San Diego

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2004

Primärer Abschluss (Tatsächlich)

1. Januar 2008

Studienabschluss (Tatsächlich)

1. Juni 2009

Studienanmeldedaten

Zuerst eingereicht

1. April 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. April 2005

Zuerst gepostet (Schätzen)

4. April 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Februar 2017

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ATN 024

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