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

27. februar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

371

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90054
        • Childrens Hosp of Los Angeles
      • San Fransisco, California, Forenede Stater, 94118
        • University of California at San Francisco
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Children's Hosp Natinal Med Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Med Center
  • Sydafrika
    • Cape Town
      • Bellville, Cape Town, Sydafrika, 7505
        • Tygerberg hospital
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2013
        • Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 24 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Standard dose (20 mcg) of Hepatitis B vaccine.
Biologisk: 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.
Aktiv komparator: 2
40 mcg of Hepatitis B vaccine
Biologisk: 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.
Aktiv komparator: 3
20 mgc of Twinrix
Biologisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sero-response to Hepatitis B Surface Antigen
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2004

Primær færdiggørelse (Faktiske)

1. januar 2008

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

1. april 2005

Først indsendt, der opfyldte QC-kriterier

1. april 2005

Først opslået (Skøn)

4. april 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. februar 2017

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ATN 024

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektion

Kliniske forsøg med Engerix-B 20 mcg

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Betingelser

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Placeringer

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