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The Human Mucosal Immune Responses to Influenza Virus (SLVP026)

27 maart 2017 bijgewerkt door: Cornelia L. Dekker, Stanford University

The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells

This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

Using state-of-the-art technology, the investigators hope the information learned from this study will help identify and describe important factors in the early-stage development of influenza immunity and possibly lead to the development of more effective vaccines. This study will be conducted in healthy male and female volunteers 18-30 years of age who received one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal spray.

Participants are divided into two groups. The control group will receive the 2012-2013 formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the first visit, they will receive a single administration of the 2012-2013 formulation of LAIV. At the second study visit two days later, they will provide a blood sample and two nasopharyngeal swab samples (one from each nostril).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

13

Fase

  • Fase 4

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 30 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Otherwise healthy, ambulatory adult between the ages of 18-30 years
  2. Willing to complete the informed consent process.
  3. Availability for follow-up at Day 2 (LAIV Group only)
  4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

Exclusion Criteria:

  1. Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
  2. Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
  3. Life-threatening reactions to previous influenza vaccinations
  4. Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
  5. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  6. History of immunodeficiency (including HIV infection)
  7. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  8. Blood pressure >150 systolic or >95 diastolic at first study visit
  9. Hospitalization in the past year for congestive heart failure or emphysema.
  10. Chronic Hepatitis B or C.
  11. Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
  12. Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
  13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
  15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety..
  17. Receipt of blood or blood products within the past 6 months of planned used during the study.
  18. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
  19. Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of the last study visit.
  20. Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of the last study visit.
  21. History of Guillain-Barré Syndrome
  22. Pregnant or lactating woman
  23. Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits.
  24. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned donation prior to completion of the last visit.
  25. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: TIV Group
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Influenza Virus Vaccine Suspension for Intramuscular Injection
Ander: LAIV Group
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Influenza Virus Vaccin Live, intranasale spray

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Aantal deelnemers uit elke arm die het griepvaccin hebben gekregen
Tijdsspanne: Dag 0 tot 28
Dag 0 tot 28

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Aantal deelnemers met gerelateerde bijwerkingen
Tijdsspanne: Dag 0 tot 28 na immunisatie
Dag 0 tot 28 na immunisatie

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Xiaosong He, PhD, Stanford Universityh

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2012

Primaire voltooiing (Werkelijk)

1 februari 2013

Studie voltooiing (Werkelijk)

1 februari 2013

Studieregistratiedata

Eerst ingediend

13 januari 2017

Eerst ingediend dat voldeed aan de QC-criteria

13 januari 2017

Eerst geplaatst (Schatting)

18 januari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 april 2017

Laatste update ingediend die voldeed aan QC-criteria

27 maart 2017

Laatst geverifieerd

1 maart 2017

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • SU-25537
  • U19AI090019 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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