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

27 febbraio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

371

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 24 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Standard dose (20 mcg) of Hepatitis B vaccine.
Biologico: 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.
Comparatore attivo: 2
40 mcg of Hepatitis B vaccine
Biologico: 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.
Comparatore attivo: 3
20 mgc of Twinrix
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sero-response to Hepatitis B Surface Antigen
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2004

Completamento primario (Effettivo)

1 gennaio 2008

Completamento dello studio (Effettivo)

1 giugno 2009

Date di iscrizione allo studio

Primo inviato

1 aprile 2005

Primo inviato che soddisfa i criteri di controllo qualità

1 aprile 2005

Primo Inserito (Stima)

4 aprile 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 febbraio 2017

Ultimo verificato

1 febbraio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ATN 024

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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