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Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine

15. august 2013 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is linked to DMID protocol 04-063 and 04-076, "A Randomized, Double Blinded, Placebo-ontrolled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults (04-063)" and also "in Healthy Elderly Adults" (04-076). All adult subjects enrolled in the main vaccine trials at Vanderbilt (04-076), Maryland (04-063), and Rochester (04-063) will be eligible for enrollment in the cell-mediated immune response sub-study. A maximum of 232 healthy ambulatory male and female subjects; 180 subjects 18 to 64 years old and 64 subjects aged 65 years and older, in the United States, could be enrolled. The primary objectives are: to establish a reproducible, functional cell-mediated immune response assay to evaluate the magnitude and functional capacity of T cells responding to monovalent subvirion H5 influenza vaccine and to evaluate the percent of subjects demonstrating a CD4+ and/or CD8+ response approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076). The secondary objectives are: to evaluate dose-related and age-related humoral immunogenicity compared to the cellular immune responses approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076) and to establish CMI assays that can be applied to future avian vaccine immunogenicity evaluation, such as the Chiron H9N2 avian influenza vaccine, future H7 vaccines, or vaccines with other avian HA molecules. The study outcome measure, immunogenicity will be based on H5 strain-specific cell-mediated immunity measured 14 days after the first, second, and third (04-076 only) dose, and month 6 after the last dose of vaccine.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

339

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Baltimore
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-2581
        • Vanderbilt University

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. All subjects who are eligible and enrolled in the main monovalent subvirion H5 vaccine trials [Division of Microbiology and Infectious Diseases (DMID) studies 04-063 and 04-076] and have agreed to the extra blood draws for the cell-mediated immunity (CMI) sub-study will be enrolled.
  2. Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
  3. Subjects who understand and sign the consent form for this study.
  4. Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
  5. Subjects who meet all inclusion criteria for the DMID study and who are vaccinated will be allowed to participate in the remaining portions of this study.

Exclusion Criteria:

1. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the cell-mediated immunity (CMI) sub-study.

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: Ikke-randomiseret

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Influenza A/H5N1
232 subjects receiving Influenza A/H5N1 vaccine.
Biologisk: Influenza A/H5N1
232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.

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)

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. oktober 2005

Primær færdiggørelse (Faktiske)

1. marts 2006

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

5. april 2006

Først indsendt, der opfyldte QC-kriterier

5. april 2006

Først opslået (Skøn)

6. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2013

Sidst verificeret

1. maj 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 05-0006

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 Influenza

Kliniske forsøg med Influenza A/H5N1

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner