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Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

13. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response.

As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.

All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, Forenede Stater, 94102
        • San Francisco Vaccine and Prevention CRS
      • San Francisco, California, Forenede Stater
        • UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Project Brave HIV Vaccine CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hosp. CRS
      • Boston, Massachusetts, Forenede Stater, 02115
        • Fenway Community Health Clinical Research Site (FCHCRS)
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Saint Louis Univ Health Sciences Ctr
    • New York
      • New York, New York, Forenede Stater, 10021
        • NY Blood Ctr./Union Square CRS
      • Rochester, New York, Forenede Stater, 14642
        • Univ. of Rochester HVTN CRS
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hospital's HVTU
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt Vaccine CRS
    • Virginia
      • Annandale, Virginia, Forenede Stater
        • Infectious Diseases Physicians, Inc.
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • FHCRC/UW Vaccine CRS

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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Participants may be eligible for this study if they:

  • Are between the ages of 18 and 60.
  • Are in good general health.
  • Have a CD4 count of 400 or more cells/mm3.
  • Do not have hepatitis C or active hepatitis B.
  • Have had a negative HIV blood test within 8 weeks prior to enrollment.
  • Use approved methods of contraception.
  • Have access to a participating site and are available for follow-up for 18 months.
  • Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
  • Give written informed consent.

Exclusion Criteria

Participants may not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Have received a live vaccine within 30 days prior to enrollment.
  • Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
  • Have used experimental research agents within 30 days prior to enrollment.
  • Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
  • Have received blood products 120 days before HIV screening.
  • Have received immunoglobulin 60 days before HIV screening.
  • Have a history of serious harmful reactions to vaccines.
  • Have a history of disease of the immune system.
  • Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
  • Are using or have used (within past 6 months) drugs that interfere with the immune system.
  • Have a history of type I or type II diabetes.
  • Have thyroid disease.
  • Have unstable asthma.
  • Are currently taking preventive anti-TB therapy.
  • Have a seizure disorder.
  • Have a bleeding disorder that was diagnosed by a physician.
  • Have had their spleen removed.
  • Have angioedema with serious episodes.
  • Have active syphilis.
  • Have hypertension.
  • Have mental problems that would interfere with the protocol.
  • Have any other problems that, in the judgment of the investigator, would interfere with the study.
  • Have a body mass index less than 20.
  • Are allergic or sensitive to egg products.
  • Have active tuberculosis.

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
  • Maskning: Dobbelt

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Paul Goepfert

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

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

Studieafslutning (Faktiske)

1. december 2005

Datoer for studieregistrering

Først indsendt

29. november 2001

Først indsendt, der opfyldte QC-kriterier

29. november 2001

Først opslået (Skøn)

30. november 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HVTN 039
  • 10200 (Anden identifikator: CTEP)

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-infektioner

Kliniske forsøg med ALVAC(2)120(B,MN)GNP (vCP1452)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kuwait

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner