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

5 oktober 2017 bijgewerkt door: National Heart, Lung, and Blood Institute (NHLBI)

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gezonde vrijwilligers

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Maryland
  - Bethesda, Maryland, Verenigde Staten, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Results of research laboratory assessments.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

Hoofdonderzoeker: Shira Y Perl, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

30 september 2009

Studie voltooiing

25 juni 2014

Studieregistratiedata

Eerst ingediend

14 oktober 2009

Eerst ingediend dat voldeed aan de QC-criteria

14 oktober 2009

Eerst geplaatst (Schatting)

15 oktober 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2017

Laatst geverifieerd