Healthy VolunteersNCT00995527
Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine
An observational study of Healthy Volunteers, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2009to 25 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed 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 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.
- Conditions
- Healthy Volunteers
- Keywords
- Post Swine Flu Blood Samples, Biologic Sample Collection, Laboratory Research Samples, H1N1 Vaccine Samples, HV, Healthy Volunteer
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of research laboratory assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study start30 Sep 2009
- Study completion25 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Shira Y Perl, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995527
- Sponsor's protocol ID
- 090245
- Other IDs
- 09-H-0245
- Status last verified
- 25 Jun 2014
- First submitted
- 14 Oct 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
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.
PubMed 12517228Neumann 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.
PubMed 19525932Zimmer 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.
PubMed 19564632
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Innate Immune Response in Healthy NIH Employees at Baseline and After Immunization With the H1N1 Vaccine
- ClinicalTrials.gov ID
- NCT00995527
- Acronym / sponsor ID
- 090245
- Conditions
- Healthy Volunteers
- Keywords
- Post Swine Flu Blood Samples, Biologic Sample Collection, Laboratory Research Samples, H1N1 Vaccine Samples, HV, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 30 Sep 2009
- Study completion
- 25 Jun 2014
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Results of research laboratory assessments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 12517228Thompson 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.
- Background: PubMed 19525932Neumann 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.
- Background: PubMed 19564632Zimmer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shira Y Perl, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of research laboratory assessments.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.