Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine
Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine
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.
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 early non-specific (innate) immune responses in adult
 recipients of the H1N1 vaccine.

 Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes
 this protocol designed to investigate the early innate immune response. Healthy adult
 subjects (NIH employees) will be admitted as inpatients to receive the FDA-licensed H1N1
 vaccine followed by serial blood draws. These samples will be used to perform comprehensive
 and detailed analyses of the innate immune system s response to vaccination. To our
 knowledge, this protocol will be the first study to characterize the human innate immune
 response to H1N1 vaccine. This information may be useful in designing newer, more effective
 vaccines to prevent the spread of H1N1.

 The primary objective is to collect blood to be used strictly for laboratory studies designed
 to characterize the innate immune response to H1N1 vaccine. Samples will be collected from
 healthy adult volunteers (NIH employees) at baseline and serially during the first 36 hours
 after vaccination with the H1N1 vaccine.
-  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)