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Studying Cell Immune Responses to a Live Flu Vaccine in Healthy Adults

NCT01730144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2019-10-18

No results posted yet for this study

Summary

Background:

\- One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus. Researchers want to better under how the live vaccine interacts with the body s immune system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt water) nasal spray. They will then look at blood and nasal cell samples to see how the vaccine affects these cells immune response.

Objectives:

\- To look at immune changes in nasal and blood cells in people who receive live flu vaccine.

Eligibility:

\- Healthy volunteers between 18 and 49 years of age.

Design:

* Participants will have five outpatient visits for this study. Each visit will last up to 2 hours.
* At the first visit, participants will have a physical exam and medical history. They will give blood and urine samples. Nasal cell samples will also be collected.
* A week later, participants will have either the nasal spray flu vaccine or a saline spray. They will know which spray they will receive. Blood samples will be collected.
* Two days after the vaccination, they will have another physical exam. Blood and nasal cell samples will be collected.
* At the final two visits (1 week and 1 month after the vaccination), more blood samples will be collected.
* Those who had the saline spray will be able to have the actual vaccine spray at the last study visit.
* The ratio of participants who receive vaccine to those who receive saline will be 4:1.

Conditions

  • Normal Physiology

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Tara N Palmore, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-17
Primary Completion
2013-04-17
Completion
2019-07-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730144 on ClinicalTrials.gov