Status:
COMPLETED
Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Brief Summary
Background: * The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting research investigating how the swine flu (H1N1) vaccine affects the immune system. The exposure to...
Detailed Description
Seasonal influenza is a major health problem whose impact is typically reduced by vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen which has the potential to cause devastating...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- NIH employees scheduled to receive the H1N1 vaccine through OMS
- Healthy status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol
- Age 18 years and older (no upper limit)
- Able to comprehend the investigational nature of the protocol and provide informed consent
- EXCLUSION CRITERIA:
- Recipient of another vaccine or immune modulating drug within 6 months prior to study entry. Seasonal influenza vaccine may be administered up to 3 days prior to enrollment or after completion of study participation (day 7 blood draw)
- Confirmed influenza within the past 1 year
- Severe allergies to eggs or their products
- Prior severe reactions to vaccines
- Participation on any blood collection or blood donation procedure during study that will bring the total blood draw \> 550m1 over 8 weeks.
- Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual)
Exclusion
Key Trial Info
Start Date :
September 30 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00995527
Start Date
September 30 2009
End Date
June 25 2014
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892