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NCT01191853 · ClinicalTrials.gov registry record
Cellular and Molecular Characterization of the Immune Response in Healthy NIH Employees atBaseline, and After Immunization With the H1N1 or Seasonal Influenza Vaccines
A clinical trial of Healthy Volunteers and Influenza, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 203
- Enrollment target
- 1
- Study location
NCT01191853: Completed study of Healthy Volunteers and Influenza, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01191853 is a study of Healthy Volunteers and Influenza that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 203 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191853, a study of Healthy Volunteers and Influenza, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 203 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Immune response to vaccine
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2009-09-18 |
What the finished NCT01191853 record still lists
NCT01191853 is an observational study that tracks outcomes without assigning an intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 0 interventions.
NCT01191853 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01191853 about?
NCT01191853 is a clinical study titled "Cellular and Molecular Characterization of the Immune Response in Healthy NIH Employees atBaseline, and After Immunization With the H1N1 or Seasonal Influenza Vaccines". 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 th...
What is the current status of trial NCT01191853?
This trial is currently completed. The enrollment target is 203 participants. The study started on 2009-09-18.
What conditions does trial NCT01191853 study?
This clinical trial studies the following conditions: Healthy Volunteers, Influenza.
Who is sponsoring clinical trial NCT01191853?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01191853 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01191853's enrollment target sits among peer trials
203 45th of 283 higher than 237 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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