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- Study Description
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Important Links and Information
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- Instructions for requestors
- Data Use Certification (DUC) Agreement
- Talking Glossary of Genetic Terms
This study includes two cohorts composed of healthy adults immunized with seasonal influenza vaccine. The first cohort was composed exclusively of males and second of females. Enrollment was restricted to individuals of European heritage to simplify the genetic analysis. Serum samples were collected prior to immunization and at 14 days and 28 days post immunization. Anti-hemagglutinin and neutralizing antibody activity was measured at each of the three time points for Influenza H1N1, H3N2, and Influenza B strains corresponding to the content of the vaccine. Peripheral blood RNA (PaxGene) were collected before immunization and on days 1, 3, and 14 post immunization. The RNA samples were analyzed using Illumina Human HT-12 v3 (Cohort 1) and Illumina HT-12 v4 beadarrays (Cohort 2).
- Study Design:
- Prospective Longitudinal Cohort
- Study Type:
- Cohort
- dbGaP estimated ancestry using GRAF-pop
- Total number of consented subjects: 246
- Subject Sample Telemetry Report (SSTR)
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- Authorized Access
- Publicly Available Data
- Link to other NCBI resources related to this study
- Study Inclusion/Exclusion Criteria
Inclusion Criteria:
- Adults age 18 to 49 at Texas A&M University and in the community.
- In good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
- Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine device, and/or a licensed hormonal method) for the study period.
Exclusion Criteria:
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in the study.
- Is planning to enroll in another clinical trial at any time during the study period.
- Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
- Has a history of alcohol or drug abuse in the last 5 years.
- Has a history of Guillain-Barre syndrome.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Is pregnant, has not practiced acceptable prophylaxis for the past three months and will not do so for the next three months, or anticipates becoming pregnant for the duration of the study.
- Is a known relative of a previously enrolled study subject.
- Positive urine pregnancy test, or breast feeding.
- Has received an influenza vaccine in the past three years.
- Has a known allergy to eggs, chicken protein or other components of the vaccine.
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Is of non-European heritage.
- Molecular Data
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Type Source Platform Number of Oligos/SNPs SNP Batch Id Comment Whole Genome Genotyping Illumina HumanOmniExpress-12v1.0 731442 N/A - Selected Publications
- Diseases/Traits Related to Study (MeSH terms)
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- Primary Phenotype: Influenza, Human
- Authorized Data Access Requests
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See articles in PMC citing this study accession
- Study Attribution
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Principal Investigator
- Robert Couch, MD. Baylor College of Medicine, Houston, Texas, USA.
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Co-Investigator
- John W. Belmont, MD, PhD. Baylor College of Medicine, Houston, Texas, USA.
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Funding Sources
- NO1-AI-030039. National Institutes of Health, Bethesda, MD, USA.
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Principal Investigator