Cellular and Molecular Characterization of the Immune Response in Healthy NIH Employees atBaseline, and After Immunization With the H1N1 or Seasonal Influenza Vaccines

NCT01191853 | Completed

• 2 other identifiers: 09023909-H-0239
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; Healthy Volunteers

Keywords

Post Swine Flu Blood Samples; Biologic Sample Collection; Laboratory Research Samples; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Analysis of immune response after vaccine

  Immune response to vaccine

  continuous

Study Arms (1)

Healthy volunteers

Healthy volunteers will have blood drawn before and after seasonal flu vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy NIH Volunteers

You may qualify if:

• NIH employees scheduled to receive the Influenza and H1N1 vaccines through OMS.
• Health 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.

You may not qualify if:

• Recipient of another vaccine or immune modulating drug within 6 months prior to study entry.
• Severe allergies to eggs or their products.
• Prior severe reactions to vaccines.
• Participation on any blood collection or blood donation procedure during study participation.
• Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual).

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1001/jama.289.2.179.

  PMID: 12517228 BACKGROUND

• Zimmer SM, Burke DS. Historical perspective--Emergence of influenza A (H1N1) viruses. N Engl J Med. 2009 Jul 16;361(3):279-85. doi: 10.1056/NEJMra0904322. Epub 2009 Jun 29. No abstract available.

  PMID: 19564632 BACKGROUND

• Taubenberger JK, Morens DM. 1918 Influenza: the mother of all pandemics. Emerg Infect Dis. 2006 Jan;12(1):15-22. doi: 10.3201/eid1201.050979.

  PMID: 16494711 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Pamela L Schwartzberg, Ph.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2010
• First Posted: August 31, 2010
• Study Start: September 18, 2009
• Last Updated: August 4, 2026

Record last verified: 2025-12-15

Locations

US (1)