Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)
16. januar 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
87
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Miami, Florida, Forente stater, 33143
- Miami Research Associates
-
-
Kansas
-
Lenexa, Kansas, Forente stater, 66219
- Johnson County Clin-Trials
-
-
Washington
-
Tacoma, Washington, Forente stater, 98418
- Northwest Kinetics
-
-
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
18 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Study Group 1
ACAM-FLU-A low dose + Adjuvant 1
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navn:
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navn:
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navn:
|
|
Eksperimentell: Study Group 2
ACAM-FLU-A low dose + Adjuvant 2
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navn:
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navn:
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navn:
|
|
Eksperimentell: Study Group 3
ACAM-FLU-A low dose
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Andre navn:
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Andre navn:
0.5 mL ACAM FLU-A low dose, Intramuscular
Andre navn:
|
|
Placebo komparator: Study Group 4
Saline placebo
|
0.5 mL, Intramuscular
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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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. juli 2007
Primær fullføring (Faktiske)
1. januar 2009
Studiet fullført (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først innsendt
10. oktober 2008
Først innsendt som oppfylte QC-kriteriene
6. januar 2009
Først lagt ut (Anslag)
8. januar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. januar 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. januar 2012
Sist bekreftet
1. januar 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-261-001
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