ID

45820

Description

Principal Investigator: Gregory A. Poland, MD, Mayo Clinic and Foundation, Rochester, MN, USA MeSH: Smallpox Vaccine https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001057 The study examines the role of candidate human immune response gene polymorphisms (and their receptors, expression and function) and variations in immune response, among 1,000 active duty members of the military who were recently vaccinated with ACAM2000 or Dryvax Smallpox vaccine. In addition to the phenotype and genotype data available through dbGaP, extensive clinical data are available through NIAID's ImmPort data portal; information to map the the data available in dbGaP to the data available in ImmPort is provided in the dataset pht005302.v1.p1 of the current study, dbGaP phs001057.v1.p1.

Link

dbGaP study = phs001057

Keywords

Versions (1)
  1. 7/3/23 7/3/23 - Simon Heim
Copyright Holder

Gregory A. Poland, MD, Mayo Clinic and Foundation, Rochester, MN, USA

Uploaded on

July 3, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs001057 Population Genetics Analysis Program: Immunity to Vaccines/Infections (NIAID/NIH)

English

Eligibility Criteria

6 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion Criteria*:Written informed consent.
Description

*Inclusion Criteria*:Written informed consent.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0021430
Age range of 18 through 40 years old.
Description

Age range of 18 through 40 years old.

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
Subject is in good health.
Description

Subject is in good health.

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1277245
If subject has any medical conditions, they must be stable - where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks.
Description

If subject has any medical conditions, they must be stable - where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks.

Data type

boolean

Alias
UMLS CUI [1,1]
C1282982
UMLS CUI [1,2]
C1611645
UMLS CUI [1,3]
C3665894
UMLS CUI [1,4]
C0019993
Subject has received one and only one dose of smallpox vaccine more than one month ago but within the last 4 years.
Description

Subject has received one and only one dose of smallpox vaccine more than one month ago but within the last 4 years.

Data type

boolean

Alias
UMLS CUI [1,1]
C0205447
UMLS CUI [1,2]
C0037355
UMLS CUI [1,3]
C0332168
Subject recalls having had a "good take" from the smallpox vaccine leaving a sore or lesion as an expected vaccine reaction that may or may not have left a scar where the vaccine was given.
Description

Subject recalls having had a "good take" from the smallpox vaccine leaving a sore or lesion as an expected vaccine reaction that may or may not have left a scar where the vaccine was given.

Data type

boolean

Alias
UMLS CUI [1,1]
C0025260
UMLS CUI [1,2]
C0037355
UMLS CUI [1,3]
C0234233
UMLS CUI [1,4]
C0221198
UMLS CUI [1,5]
C0413534
UMLS CUI [1,6]
C1517001
UMLS CUI [1,7]
C2004491
Subject is able to follow study procedures.
Description

Subject is able to follow study procedures.

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1299581
UMLS CUI [1,3]
C4281991
UMLS CUI [1,4]
C2348563
Subject agrees NOT to donate blood in the next 56 days.
Description

Subject agrees NOT to donate blood in the next 56 days.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C1518422
UMLS CUI [1,3]
C2145403
UMLS CUI [1,4]
C0332168
*Exclusion Criteria*:Subject has donated blood within the last 56 days.
Description

*Exclusion Criteria*:Subject has donated blood within the last 56 days.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2145403
UMLS CUI [1,3]
C0332168
Subject has a known or suspected immunodeficiency or is receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g. for cancer, HIV, or autoimmune disease.
Description

Subject has a known or suspected immunodeficiency or is receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g. for cancer, HIV, or autoimmune disease.

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0205309
UMLS CUI [1,3]
C0277540
UMLS CUI [1,4]
C0021051
UMLS CUI [1,5]
C0087111
UMLS CUI [1,6]
C0021079
UMLS CUI [1,7]
C0304497
UMLS CUI [1,8]
C3653708
UMLS CUI [1,9]
C0006826
UMLS CUI [1,10]
C0019682
UMLS CUI [1,11]
C0004364
Subject has received systemic corticosteroids for treatment of an acute illness in the last 30 days.
Description

Subject has received systemic corticosteroids for treatment of an acute illness in the last 30 days.

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C4061114
UMLS CUI [1,4]
C0332168
Subject has a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study.
Description

Subject has a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C4698656
UMLS CUI [1,4]
C0730607
UMLS CUI [1,5]
C1514873
UMLS CUI [1,6]
C4534306
UMLS CUI [1,7]
C0022661
UMLS CUI [1,8]
C4551529
UMLS CUI [1,9]
C0018799
UMLS CUI [1,10]
C0443343
Subject has received any blood products, including immunoglobulin, within 6 months of study enrollment.
Description

Subject has received any blood products, including immunoglobulin, within 6 months of study enrollment.

Data type

boolean

Alias
UMLS CUI [1,1]
C5441444
UMLS CUI [1,2]
C0332168
Subject is excluded if they ever contracted a rash or some other disease as a result of direct exposure to another person's smallpox vaccination reaction.
Description

Subject is excluded if they ever contracted a rash or some other disease as a result of direct exposure to another person's smallpox vaccination reaction.

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1140999
UMLS CUI [1,3]
C0015230
UMLS CUI [1,4]
C3203558
UMLS CUI [1,5]
C0413551
Subject has any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.
Description

Subject has any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C4745084
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0220825
UMLS CUI [1,5]
C2985627
Subject previously participated in this particular study.
Description

Subject previously participated in this particular study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0947630
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Similar models

Eligibility Criteria

6 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])
*Inclusion Criteria*:Written informed consent.
Item
*Inclusion Criteria*:Written informed consent.
boolean
C1512693 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Age range of 18 through 40 years old.
Item
Age range of 18 through 40 years old.
boolean
C0001779 (UMLS CUI [1,1])
Subject is in good health.
Item
Subject is in good health.
boolean
C0681850 (UMLS CUI [1,1])
C1277245 (UMLS CUI [1,2])
If subject has any medical conditions, they must be stable - where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks.
Item
If subject has any medical conditions, they must be stable - where stable is defined as not requiring either a significant change in therapy or a hospitalization in the last 12 weeks.
boolean
C1282982 (UMLS CUI [1,1])
C1611645 (UMLS CUI [1,2])
C3665894 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,4])
Subject has received one and only one dose of smallpox vaccine more than one month ago but within the last 4 years.
Item
Subject has received one and only one dose of smallpox vaccine more than one month ago but within the last 4 years.
boolean
C0205447 (UMLS CUI [1,1])
C0037355 (UMLS CUI [1,2])
C0332168 (UMLS CUI [1,3])
Subject recalls having had a "good take" from the smallpox vaccine leaving a sore or lesion as an expected vaccine reaction that may or may not have left a scar where the vaccine was given.
Item
Subject recalls having had a "good take" from the smallpox vaccine leaving a sore or lesion as an expected vaccine reaction that may or may not have left a scar where the vaccine was given.
boolean
C0025260 (UMLS CUI [1,1])
C0037355 (UMLS CUI [1,2])
C0234233 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,4])
C0413534 (UMLS CUI [1,5])
C1517001 (UMLS CUI [1,6])
C2004491 (UMLS CUI [1,7])
Subject is able to follow study procedures.
Item
Subject is able to follow study procedures.
boolean
C0681850 (UMLS CUI [1,1])
C1299581 (UMLS CUI [1,2])
C4281991 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Subject agrees NOT to donate blood in the next 56 days.
Item
Subject agrees NOT to donate blood in the next 56 days.
boolean
C0680240 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
C2145403 (UMLS CUI [1,3])
C0332168 (UMLS CUI [1,4])
*Exclusion Criteria*:Subject has donated blood within the last 56 days.
Item
*Exclusion Criteria*:Subject has donated blood within the last 56 days.
boolean
C0680251 (UMLS CUI [1,1])
C2145403 (UMLS CUI [1,2])
C0332168 (UMLS CUI [1,3])
Subject has a known or suspected immunodeficiency or is receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g. for cancer, HIV, or autoimmune disease.
Item
Subject has a known or suspected immunodeficiency or is receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (e.g. for cancer, HIV, or autoimmune disease.
boolean
C0681850 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
C0277540 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
C0021079 (UMLS CUI [1,6])
C0304497 (UMLS CUI [1,7])
C3653708 (UMLS CUI [1,8])
C0006826 (UMLS CUI [1,9])
C0019682 (UMLS CUI [1,10])
C0004364 (UMLS CUI [1,11])
Subject has received systemic corticosteroids for treatment of an acute illness in the last 30 days.
Item
Subject has received systemic corticosteroids for treatment of an acute illness in the last 30 days.
boolean
C3653708 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C4061114 (UMLS CUI [1,3])
C0332168 (UMLS CUI [1,4])
Subject has a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study.
Item
Subject has a serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigators opinion precludes the subject from participating in the study.
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C4698656 (UMLS CUI [1,3])
C0730607 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C4534306 (UMLS CUI [1,6])
C0022661 (UMLS CUI [1,7])
C4551529 (UMLS CUI [1,8])
C0018799 (UMLS CUI [1,9])
C0443343 (UMLS CUI [1,10])
Subject has received any blood products, including immunoglobulin, within 6 months of study enrollment.
Item
Subject has received any blood products, including immunoglobulin, within 6 months of study enrollment.
boolean
C5441444 (UMLS CUI [1,1])
C0332168 (UMLS CUI [1,2])
Subject is excluded if they ever contracted a rash or some other disease as a result of direct exposure to another person's smallpox vaccination reaction.
Item
Subject is excluded if they ever contracted a rash or some other disease as a result of direct exposure to another person's smallpox vaccination reaction.
boolean
C2828389 (UMLS CUI [1,1])
C1140999 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,3])
C3203558 (UMLS CUI [1,4])
C0413551 (UMLS CUI [1,5])
Subject has any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.
Item
Subject has any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives.
boolean
C0681850 (UMLS CUI [1,1])
C4745084 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C2985627 (UMLS CUI [1,5])
Subject previously participated in this particular study.
Item
Subject previously participated in this particular study.
boolean
C0681850 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0947630 (UMLS CUI [1,4])
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