Protocol Details
Cellular and Molecular Characterization of the Immune Response in Healthy NIH Employees at Baseline, and After Immunization with the H1N1 or Seasonal Influenza Vaccines
This study is NOT currently recruiting participants.
Summary
Number |
09-H-0239 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Post Swine Flu Blood Samples;
Biologic Sample Collection;
Laboratory Research Samples;
Natural History |
Recruitment Keyword(s) |
Healthy Volunteer;
HV |
Condition(s) |
Healthy Volunteers;
Influenza |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Heart, Lung, and Blood Institute |
Background:
- Seasonal influenza is a major health problem whose impact is typically reduced by vaccination. The H1N1 (swine flu) influenza virus is an emerging pathogen that has the potential to cause devastating illness and even death in the coming months. Currently, there are limited data on the cellular and molecular immune responses in adult recipients of either the seasonal or the H1N1 influenza vaccines.
Objectives:
- To obtain blood and nasal wash samples and perform laboratory studies to characterize the immune response in healthy adult volunteers at baseline and after immunization with the seasonal or H1N1 influenza vaccines.
Eligibility:
- Adult employees at least 18 years of age of the NIH Clinical Center who are deemed healthy by a brief medical history and physical examination and routine blood testing.
Design:
- Before the start of the influenza season, volunteers will receive either the seasonal influenza vaccine or the H1N1 vaccine when it becomes available. If the H1N1 vaccine is available at the start of the season, volunteers will receive both the seasonal vaccine and the H1N1 vaccine.
- Blood will be drawn over an 8-week period. Volunteers must not eat anything for 8 hours prior to the blood draw. The sequence of the blood draws is as follows: 2 weeks before vaccination; right before vaccination; and 1, 7, 14, 28, and 60 days after vaccination.
- Two to four nasal washings will be collected by a nurse before volunteers receive the vaccination(s) and 28 days after the vaccination.
- Prevaccine and postvaccine blood and nasal wash samples will be compared to determine volunteers immune responses.
- Research samples will be stored indefinitely and will be used strictly for laboratory experiments.
Eligibility
INCLUSION CRITERIA:
1. NIH employees scheduled to receive the Influenza and H1N1 vaccines through OMS.
2. Health status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol.
3. Age 18 years and older (no upper limit).
4. Able to comprehend the investigational nature of the protocol and provide informed consent.
EXCLUSION CRITERIA:
1. Recipient of another vaccine or immune modulating drug within 6 months prior to study entry.
2. Severe allergies to eggs or their products.
3. Prior severe reactions to vaccines.
4. Participation on any blood collection or blood donation procedure during study participation.
5. Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual).
Citations:
Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86.
Zimmer SM, Burke DS. Historical perspective--Emergence of influenza A (H1N1) viruses. N Engl J Med. 2009 Jul 16;361(3):279-85. Epub 2009 Jun 29.
Taubenberger JK, Morens DM. 1918 Influenza: the mother of all pandemics. Emerg Infect Dis. 2006 Jan;12(1):15-22.
Contacts:
Clinical Trials Number:
NCT01191853