Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine

NCT00995527 | Completed

• 2 other identifiers: 09024509-H-0245
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is conducting research investigating how the swine flu (H1N1) vaccine affects the immune system. The exposure to the new swine flu vaccine gives us a rare opportunity to learn about how the human immune system responds to a new vaccine.
• Researchers are interested in collecting blood samples from individuals who have received the vaccine. Participants will be selected from a group of healthy volunteers who will be receiving the H1N1 vaccine because it is mandatory for their work at the National Institutes of Health. This protocol will be one of the first studies to characterize the human innate immune response to H1N1 vaccine. Objectives: \- To collect blood samples for research purposes before and after participants receive a standard non-research vaccination against swine flu (H1N1). Eligibility:
• Healthy individuals 18 years of age and older who are employees of the National Institutes of Health.
• Individuals who have had confirmed cases of influenza in the past year are not eligible to participate. Design:
• Participants will be admitted for a 36-hour inpatient stay, during which blood samples will be taken frequently. Participants will have a standard intravenous catheter (similar to the one used for intravenous infusions) put in place to avoid multiple needle sticks.
• Participants will be assigned into one of two groups; the two groups differ in the timing of blood draws but not in the overall amount of blood drawn.
• Group 1: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, and 36 hours after vaccination.
• Group 2: Blood samples 30 minutes before and immediately before vaccination. Additional samples will be taken over the following 36 hours, with exact timing to be determined based on the findings from group 1.
• All participants will provide blood samples 7 days after being released from the inpatient stay.
• Because of the amount of blood being drawn for research, participants should not donate blood or take part in any other protocols that collect blood while participating in this study.

Conditions

Healthy Volunteers

Keywords

Post Swine Flu Blood Samples; Biologic Sample Collection; Laboratory Research Samples; H1N1 Vaccine Samples; HV; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Results of research laboratory assessments.

Eligibility Criteria

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

You may qualify if:

• NIH employees scheduled to receive the H1N1 vaccine through OMS
• Healthy 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. Seasonal influenza vaccine may be administered up to 3 days prior to enrollment or after completion of study participation (day 7 blood draw)
• Confirmed influenza within the past 1 year
• Severe allergies to eggs or their products
• Prior severe reactions to vaccines
• Participation on any blood collection or blood donation procedure during study that will bring the total blood draw \> 550m1 over 8 weeks.
• 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, 9000 Rockville Pike

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

• Neumann G, Noda T, Kawaoka Y. Emergence and pandemic potential of swine-origin H1N1 influenza virus. Nature. 2009 Jun 18;459(7249):931-9. doi: 10.1038/nature08157.

  PMID: 19525932 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

Study Officials

• Shira Y Perl, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: September 30, 2009
• Study Completion: June 25, 2014
• Last Updated: October 6, 2017

Record last verified: 2014-06-25

Locations

US (1)