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- Study Description
The study sequenced antibody heavy chain gene rearrangements from human subjects receiving influenza vaccination.
- Study Type: Longitudinal
Number of study subjects that have individual level data available through Authorized Access: 27
- Authorized Access
- Publicly Available Data (Public ftp)
Connect to the public download site. The site contains release notes and manifests. If available, the site also contains data dictionaries, variable summaries, documents, and truncated analyses.
- Study Inclusion/Exclusion Criteria
- Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment
- General good health and ambulatory at time of enrollment
- No acute illness at time of vaccination
- Willing and able to sign Informed Consent
- Available for follow-up for the planned duration of the study
- Acceptable medical history by screening evaluation and brief clinical assessment
- All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study
- Off-study vaccination during the period of the study
- Allergy to egg or egg products
- Allergy to vaccine components, including thimerosal
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency
- Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Blood pressure > 150 systolic or > 95 diastolic at Visit 1
- Chronic Hepatitis B or C
- Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (< 20mg predisone - equivalent/day) may be acceptable after review by the investigator.
- Autoimmune disease
- History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Receipt of blood or blood products within the past 6 months
- Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
- Receipt of inactivated vaccine within 14 days prior to vaccination
- Receipt of live, attenuated vaccine within 60 days of vaccination
- History of Guillain-Barré Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
- Molecular Data
Type Source Platform Number of Oligos/SNPs SNP Batch Id Comment IGH Amplicon DNA Sequencing Roche 454 GS FLX Titanium N/A N/A
- Selected publications
- Diseases/Traits Related to Study (MESH terms)
- Authorized Data Access Requests
- Study Attribution