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The Human Mucosal Immune Responses to Influenza Virus (SLVP026)

27 de marzo de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

13

Fase

  • Fase 4

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 30 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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
Otro: LAIV Group
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
Vacuna viva contra el virus de la influenza, aerosol intranasal

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Número de participantes de cada brazo que recibieron la vacuna contra la influenza
Periodo de tiempo: Día 0 al 28
Día 0 al 28

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Número de participantes con eventos adversos relacionados
Periodo de tiempo: Día 0 a 28 post vacunación
Día 0 a 28 post vacunación

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Xiaosong He, PhD, Stanford Universityh

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2012

Finalización primaria (Actual)

1 de febrero de 2013

Finalización del estudio (Actual)

1 de febrero de 2013

Fechas de registro del estudio

Enviado por primera vez

13 de enero de 2017

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2017

Publicado por primera vez (Estimar)

18 de enero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

27 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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