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

NCT01191853 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 203

Last updated 2026-04-08

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Pamela L Schwartzberg, Ph.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-18

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01191853 on ClinicalTrials.gov