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ID
45571
Description
Principal Investigator: Stephen R. Quake, Departments of Biophysics and Bioengineering, Stanford University and Howard Hughes Medical Institute, Palo Alto, CA, USA MeSH: Influenza Vaccines,B-Lymphocytes https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000656 We developed an improved high throughput sequencing approach to measure the quantities and sequences of the repertoire of antibody heavy chain RNA in a blood sample. Using this approach we analyzed the antibody repertoire in response to yearly vaccinations with influenza vaccines TIV and LAIV in healthy adults in two subsequent years. We determined vaccine response patterns specific to LAIV and TIV and found antibody sequences that were shared between two samples of the same individuals following influenza vaccination in subsequent years, thereby providing a genetic measurement of B-cell memory recall.
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Versions (1)
- 1/23/23 1/23/23 - Dr. Christian Niklas
Copyright Holder
Stephen R. Quake, Departments of Biophysics and Bioengineering, Stanford University and Howard Hughes Medical Institute, Palo Alto, CA, USA
Uploaded on
January 23, 2023
DOI
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License
Creative Commons BY 4.0
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dbGaP phs000656 Genetic Measurement of Memory B-cell Recall Using Antibody Repertoire Sequencing
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This data table contains subject IDs and consent information.
- This data table contains mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype table includes sex, calculated age at consent, race, and ethnicity.
- This sample attributes table includes body site where sample was extracted, analyte type, tumor status, and sequencing center.
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Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- This data table contains subject IDs and consent information.
- This data table contains mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
- This subject phenotype table includes sex, calculated age at consent, race, and ethnicity.
- This sample attributes table includes body site where sample was extracted, analyte type, tumor status, and sequencing center.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.1
Item
*Subject Inclusion Criteria*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.2
Item
Otherwise healthy, 18-30 year old young adult.
boolean
C0001779 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
C1708335 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.3
Item
Acceptable medical history by medical history and vital signs.
boolean
C0262926 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0518766 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Elig.phs000656.v1.p1.4
Item
*Subject Exclusion Criteria*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.5
Item
Prior vaccination with 2010-2011 seasonal TIV or LAIV.
boolean
C0042196 (UMLS CUI [1,1])
C0770694 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C1456404 (UMLS CUI [2,2])
C0770694 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C1456404 (UMLS CUI [2,2])
Elig.phs000656.v1.p1.6
Item
Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV.
boolean
C0042196 (UMLS CUI [1,1])
C0770694 (UMLS CUI [1,2])
C1518546 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C1456404 (UMLS CUI [2,2])
C1518546 (UMLS CUI [2,3])
C0770694 (UMLS CUI [1,2])
C1518546 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C1456404 (UMLS CUI [2,2])
C1518546 (UMLS CUI [2,3])
Elig.phs000656.v1.p1.7
Item
Weight less than 110 pounds.
boolean
C0005910 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.8
Item
Allergy to egg or egg products, or to vaccine components, including gelatin, or thimerosal (TIV multidose vials only).
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.9
Item
Life-threatening reactions to previous influenza vaccinations.
boolean
C1517874 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
C0021403 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.10
Item
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.11
Item
History of immunodeficiency (including HIV infection).
boolean
C0019693 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.12
Item
Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
boolean
C4062321 (UMLS CUI [1,1])
C0021053 (UMLS CUI [1,2])
C0021053 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.13
Item
Blood pressure >150 systolic or >95 diastolic at first study visit.
boolean
C0020538 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.14
Item
Hospitalization in the past year for congestive heart failure or emphysema.
boolean
C0018802 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0034067 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0019993 (UMLS CUI [1,2])
C0034067 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
Elig.phs000656.v1.p1.15
Item
Chronic Hepatitis B or C.
boolean
C0019163 (UMLS CUI [1,1])
C0019196 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,1])
Elig.phs000656.v1.p1.16
Item
Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; after review by the investigator.
boolean
C0021081 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0332185 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Elig.phs000656.v1.p1.17
Item
Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
boolean
C0006826 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.18
Item
Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [2,1])
C0003873 (UMLS CUI [3,1])
C0035435 (UMLS CUI [2,1])
C0003873 (UMLS CUI [3,1])
Elig.phs000656.v1.p1.19
Item
History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year.
boolean
C0019045 (UMLS CUI [1,1])
C0018939 (UMLS CUI [2,1])
C0035078 (UMLS CUI [3,1])
C0018939 (UMLS CUI [2,1])
C0035078 (UMLS CUI [3,1])
Elig.phs000656.v1.p1.20
Item
Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
boolean
C0003280 (UMLS CUI [1,1])
C0085826 (UMLS CUI [2,1])
C0085826 (UMLS CUI [2,1])
Elig.phs000656.v1.p1.21
Item
Receipt of blood or blood products within the past 6 months.
boolean
C1533734 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.22
Item
Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.23
Item
Receipt of inactivated vaccine 14 days prior to enrollment (14 days prior to vaccination) and within 28 days after vaccination.
boolean
C0042212 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.24
Item
Live, attenuated vaccine within 55 days of enrollment (60 days of vaccination).
boolean
C1516086 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.25
Item
History of Guillain-Barré Syndrome.
boolean
C0018378 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.26
Item
Pregnant or lactating woman.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,1])
Elig.phs000656.v1.p1.27
Item
Use of investigational agents within 30 days prior to enrollment.
boolean
C0013230 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
Elig.phs000656.v1.p1.28
Item
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment. Needs f/u.
boolean
C0005794 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.29
Item
A member of the study team or their family member, to include investigators, research laboratory staff, clinical research staff.
boolean
C1552089 (UMLS CUI [1,1])
Elig.phs000656.v1.p1.30
Item
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.
boolean
C1302261 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,2])