ID

45584

Description

Principal Investigator: Scott D. Boyd, MD, PhD, Stanford University, Stanford, CA, USA MeSH: Influenza Vaccines,Aged https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000666 The study sequenced antibody heavy chain gene rearrangements from human subjects receiving influenza vaccination.

Link

dbGaP-study=phs000666

Keywords

Versions (1)
  1. 1/28/23 1/28/23 - Chiara Middel
Copyright Holder

Scott D. Boyd, MD, PhD, Stanford University, Stanford, CA, USA

Uploaded on

January 28, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs000666 B and T Cell Determinants of Influenza Vaccine Responses in the Elderly

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion:*
Description

Elig.phs000666.v1.p1.1

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment
Description

Elig.phs000666.v1.p1.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1516879
General good health and ambulatory at time of enrollment
Description

Elig.phs000666.v1.p1.3

Data type

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1516879
No acute illness at time of vaccination
Description

Elig.phs000666.v1.p1.4

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C4061114
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0042196
Willing and able to sign Informed Consent
Description

Elig.phs000666.v1.p1.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
Available for follow-up for the planned duration of the study
Description

Elig.phs000666.v1.p1.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
Acceptable medical history by screening evaluation and brief clinical assessment
Description

Elig.phs000666.v1.p1.7

Data type

boolean

Alias
UMLS CUI [1,1]
C1879533
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0220908
UMLS CUI [1,4]
C0220825
UMLS CUI [1,5]
C4534461
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
Description

Elig.phs000666.v1.p1.8

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0427780
*Exclusion:*
Description

Elig.phs000666.v1.p1.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
Off-study vaccination during the period of the study
Description

Elig.phs000666.v1.p1.10

Data type

boolean

Alias
UMLS CUI [1,1]
C1518546
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0489652
Allergy to egg or egg products
Description

Elig.phs000666.v1.p1.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0559469
Allergy to vaccine components, including thimerosal
Description

Elig.phs000666.v1.p1.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
Description

Elig.phs000666.v1.p1.13

Data type

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0442893
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0743842
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0042196
History of immunodeficiency
Description

Elig.phs000666.v1.p1.14

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0021051
Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
Description

Elig.phs000666.v1.p1.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [1,4]
C0525058
Blood pressure > 150 systolic or > 95 diastolic at Visit 1
Description

Elig.phs000666.v1.p1.16

Data type

boolean

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0871470
Chronic Hepatitis B or C
Description

Elig.phs000666.v1.p1.17

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0524909
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.
Description

Elig.phs000666.v1.p1.18

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C2825233
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0680251
UMLS CUI [2,3]
C3539185
UMLS CUI [2,4]
C2065041
UMLS CUI [3,1]
C1527415
UMLS CUI [3,2]
C0038317
UMLS CUI [3,3]
C1704362
UMLS CUI [3,4]
C0031831
Autoimmune disease
Description

Elig.phs000666.v1.p1.19

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
Description

Elig.phs000666.v1.p1.20

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019045
UMLS CUI [1,3]
C0018939
UMLS CUI [1,4]
C0205272
UMLS CUI [1,5]
C1522577
UMLS CUI [1,6]
C1708385
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.
Description

Elig.phs000666.v1.p1.21

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C0003280
UMLS CUI [1,4]
C4700122
UMLS CUI [1,5]
C0728963
UMLS CUI [1,6]
C0031831
UMLS CUI [1,7]
C1704362
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0457083
UMLS CUI [2,3]
C2963157
UMLS CUI [2,4]
C0004057
UMLS CUI [2,5]
C0633084
UMLS CUI [2,6]
C0732282
UMLS CUI [2,7]
C0031831
UMLS CUI [2,8]
C1704362
Receipt of blood or blood products within the past 6 months
Description

Elig.phs000666.v1.p1.22

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0371802
UMLS CUI [1,3]
C3828652
Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
Description

Elig.phs000666.v1.p1.23

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0043227
UMLS CUI [1,4]
C0678341
UMLS CUI [1,5]
C0439801
UMLS CUI [1,6]
C1321605
Receipt of inactivated vaccine within 14 days prior to vaccination
Description

Elig.phs000666.v1.p1.24

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0042212
UMLS CUI [1,3]
C4071839
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0042196
Receipt of live, attenuated vaccine within 60 days of vaccination
Description

Elig.phs000666.v1.p1.25

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0042211
UMLS CUI [1,4]
C3846158
History of Guillain-Barré Syndrome
Description

Elig.phs000666.v1.p1.26

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018378
Pregnant or lactating woman
Description

Elig.phs000666.v1.p1.27

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Use of investigational agents within 30 days prior to enrollment
Description

Elig.phs000666.v1.p1.28

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1516879
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
Description

Elig.phs000666.v1.p1.29

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C1516879
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.
Description

Elig.phs000666.v1.p1.30

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [1,4]
C1113679
UMLS CUI [1,5]
C0525058
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Similar models

Eligibility Criteria

5 forms
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])
Elig.phs000666.v1.p1.1
Item
*Inclusion:*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.2
Item
Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment
boolean
C0001779 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.3
Item
General good health and ambulatory at time of enrollment
boolean
C1277245 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.4
Item
No acute illness at time of vaccination
boolean
C1298908 (UMLS CUI [1,1])
C4061114 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.5
Item
Willing and able to sign Informed Consent
boolean
C0021430 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.6
Item
Available for follow-up for the planned duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.7
Item
Acceptable medical history by screening evaluation and brief clinical assessment
boolean
C1879533 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C4534461 (UMLS CUI [1,5])
Elig.phs000666.v1.p1.8
Item
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
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.9
Item
*Exclusion:*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.10
Item
Off-study vaccination during the period of the study
boolean
C1518546 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0489652 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.11
Item
Allergy to egg or egg products
boolean
C0559469 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.12
Item
Allergy to vaccine components, including thimerosal
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.13
Item
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
boolean
C0205177 (UMLS CUI [1,1])
C0442893 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0743842 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Elig.phs000666.v1.p1.14
Item
History of immunodeficiency
boolean
C0262926 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.15
Item
Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
boolean
C0008679 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.16
Item
Blood pressure > 150 systolic or > 95 diastolic at Visit 1
boolean
C0428883 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.17
Item
Chronic Hepatitis B or C
boolean
C0524910 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.18
Item
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.
boolean
C0332185 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2825233 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C3539185 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
C1527415 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1704362 (UMLS CUI [3,3])
C0031831 (UMLS CUI [3,4])
Elig.phs000666.v1.p1.19
Item
Autoimmune disease
boolean
C0004364 (UMLS CUI [1,1])
Elig.phs000666.v1.p1.20
Item
History of blood dyscrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
boolean
C0262926 (UMLS CUI [1,1])
C0019045 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,3])
C0205272 (UMLS CUI [1,4])
C1522577 (UMLS CUI [1,5])
C1708385 (UMLS CUI [1,6])
Elig.phs000666.v1.p1.21
Item
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.
boolean
C0521116 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C4700122 (UMLS CUI [1,4])
C0728963 (UMLS CUI [1,5])
C0031831 (UMLS CUI [1,6])
C1704362 (UMLS CUI [1,7])
C0521116 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C2963157 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C0633084 (UMLS CUI [2,5])
C0732282 (UMLS CUI [2,6])
C0031831 (UMLS CUI [2,7])
C1704362 (UMLS CUI [2,8])
Elig.phs000666.v1.p1.22
Item
Receipt of blood or blood products within the past 6 months
boolean
C1709854 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.23
Item
Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
boolean
C3843040 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0043227 (UMLS CUI [1,3])
C0678341 (UMLS CUI [1,4])
C0439801 (UMLS CUI [1,5])
C1321605 (UMLS CUI [1,6])
Elig.phs000666.v1.p1.24
Item
Receipt of inactivated vaccine within 14 days prior to vaccination
boolean
C1709854 (UMLS CUI [1,1])
C0042212 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Elig.phs000666.v1.p1.25
Item
Receipt of live, attenuated vaccine within 60 days of vaccination
boolean
C1709854 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0042211 (UMLS CUI [1,3])
C3846158 (UMLS CUI [1,4])
Elig.phs000666.v1.p1.26
Item
History of Guillain-Barré Syndrome
boolean
C0262926 (UMLS CUI [1,1])
C0018378 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.27
Item
Pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Elig.phs000666.v1.p1.28
Item
Use of investigational agents within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Elig.phs000666.v1.p1.29
Item
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1516879 (UMLS CUI [1,5])
Elig.phs000666.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
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
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