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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191853
• Other study ID #: 090239
• Secondary ID: 09-H-0239
• Status: Completed
• Start date: September 18, 2009

Study information

• Verified date: June 7, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 morbidity and mortality in the coming months. In June 2009, the World Health Organization declared the H1N1 outbreak to be a global pandemic. At present there are limited data on the cellular and molecular immune responses in adult recipients of either the seasonal or the H1N1 influenza vaccines. Therefore, the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects (NIH employees) prior to vaccination and then at various time points after receiving the FDA-licensed seasonal and H1N1 influenza vaccine. These samples will be used to perform a comprehensive and detailed analysis of the immune system at baseline and in response to vaccination. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in a large number of healthy adults (NIH employees). This information may be useful in designing newer, more effective vaccines to prevent the spread of H1N1 influenza. The primary objective is to perform laboratory studies to characterize the immune response in healthy adult volunteers at baseline and after immunization with the seasonal or H1N1 influenza vaccines. Primary endpoint is the results of the research laboratory assessments. As samples will be stored indefinitely, the time frame for primary endpoint is indefinite.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Healthy Volunteers
• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of immune response after vaccine	Immune response to vaccine	continuous

External Links

•   NIH Clinical Center Detailed Web Page