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Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

16. januar 2012 opdateret af: Sanofi

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

87

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
    • Florida
      • Miami, Florida, Forenede Stater, 33143
        • Miami Research Associates
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County Clin-Trials
    • Washington
      • Tacoma, Washington, Forenede Stater, 98418
        • Northwest Kinetics

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 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria:

  • Known allergies or severe reactions to any of the vaccine components including those to adjuvants
  • History of severe allergic reactions, including angioedema;
  • History of asthma or recurrent wheezing; (current or within past 2 years);
  • History of neurological symptoms or signs following administration of any vaccine;

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Study Group 1
ACAM-FLU-A low dose + Adjuvant 1
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navne:
  • ACAM FLU-A
Eksperimentel: Study Group 2
ACAM-FLU-A low dose + Adjuvant 2
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navne:
  • ACAM FLU-A
Eksperimentel: Study Group 3
ACAM-FLU-A low dose
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navne:
  • ACAM FLU-A
Biologisk: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navne:
  • ACAM FLU-A
Placebo komparator: Study Group 4
Saline placebo
Biologisk: Saline placebo
0.5 mL, Intramuscular
Andre navne:
  • USP Saline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Tidsramme: Day 0 through Day 60 post-vaccination
Day 0 through Day 60 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 through Day 7 post-vaccination
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Day 0 through Day 7 post-vaccination
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 through Day 60 post-vaccination 1
Day 0 through Day 60 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Tidsramme: Day 15 through Month 10 Post-vaccination 1
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 15 through Month 10 Post-vaccination 1
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Tidsramme: Day 15 through Month 10 Post-vaccination 1

Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).

A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Day 15 through Month 10 Post-vaccination 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Month 4 through Month 10 post-vaccination 1
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Month 4 through Month 10 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 and Day 60 Post-vaccination 1
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 and Day 60 Post-vaccination 1

Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).

A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 and Day 60 Post-vaccination 1
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 and Day 15 through Month 10 post-vaccination 1
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 0 and Day 15 through Month 10 post-vaccination 1
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Tidsramme: Day 0 and Day 15 through Month 10 Post-vaccination 1

Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.

Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Day 0 and Day 15 through Month 10 Post-vaccination 1

Samarbejdspartnere og efterforskere

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

Sponsor

Sanofi

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

Studiestart

1. juli 2007

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først indsendt

10. oktober 2008

Først indsendt, der opfyldte QC-kriterier

6. januar 2009

Først opslået (Skøn)

8. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-261-001

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 .

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Betingelser

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