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

27 février 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

371

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 24 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 1
Standard dose (20 mcg) of Hepatitis B vaccine.
Biologique: 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.
Comparateur actif: 2
40 mcg of Hepatitis B vaccine
Biologique: 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.
Comparateur actif: 3
20 mgc of Twinrix
Biologique: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sero-response to Hepatitis B Surface Antigen
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of North Carolina, Chapel Hill

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2004

Achèvement primaire (Réel)

1 janvier 2008

Achèvement de l'étude (Réel)

1 juin 2009

Dates d'inscription aux études

Première soumission

1 avril 2005

Première soumission répondant aux critères de contrôle qualité

1 avril 2005

Première publication (Estimation)

4 avril 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mars 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 février 2017

Dernière vérification

1 février 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ATN 024

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Infection par le VIH

Essais cliniques sur Engerix-B 20 mcg

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