Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	09-H-0245
Sponsoring Institute	National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Post Swine Flu Blood Samples; Biologic Sample Collection; Laboratory Research Samples; H1N1 Vaccine Samples
Recruitment Keyword(s)	HV; Healthy Volunteer
Condition(s)	Healthy Volunteers
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Heart, Lung, and Blood Institute

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.

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Eligibility

INCLUSION CRITERIA:

- 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

EXCLUSION CRITERIA:

- 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)

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Citations:

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

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

Zimmer SM, Burke DS. Historical perspective--Emergence of influenza A (H1N1) viruses. N Engl J Med. 2009 Jul 16;361(3):279-85. Epub 2009 Jun 29

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Contacts:

Principal Investigator	Referral Contact	For more information:
Shira Y. Perl, M.D. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health BG 10 RM 7N116B 10 CENTER DR BETHESDA MD 20892 (301) 594-0512 perls@mail.nih.gov	Shira Y. Perl, M.D. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health BG 10 RM 7N116B 10 CENTER DR BETHESDA MD 20892 (301) 594-0512 perls@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00995527

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