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

27. februar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

371

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 24 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2004

Primær fullføring (Faktiske)

1. januar 2008

Studiet fullført (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først innsendt

1. april 2005

Først innsendt som oppfylte QC-kriteriene

1. april 2005

Først lagt ut (Anslag)

4. april 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. februar 2017

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ATN 024

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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