Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease | Hemodialysis
Item
has loss of renal function and is receiving hemodialysis treatments
boolean
C1561643 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Infection protection Absent Hepatitis B | Hepatitis B surface antibody measurement
Item
is not seroprotected against hepatitis b (has anti-hbs < 10 miu/ml)
boolean
C0150259 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0201478 (UMLS CUI [2])
Stable status Clinical
Item
in the opinion of the investigator, is clinically stable
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Seronegative Hepatitis B Surface Antigens | Seronegative Antibody to hepatitis B core antigen | Seronegative Hepatitis C virus | Seronegative HIV
Item
be serum negative for hbsag, anti-hepatitis b core antigen (hbc), hepatitis c virus (hcv), and hiv
boolean
C0521144 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0521144 (UMLS CUI [2,1])
C0312631 (UMLS CUI [2,2])
C0521144 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0521144 (UMLS CUI [4,1])
C0019682 (UMLS CUI [4,2])
Absence Treatment schedule Kidney Transplantation
Item
is not scheduled to undergo a kidney transplant during the study period
boolean
C0332197 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0022671 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Female Sterilization | Pregnancy Absent | Breast Feeding Absent | Contraceptive methods Quantity
Item
if female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
if female, is pregnant, breastfeeding, or planning a pregnancy;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Exposure to Hepatitis B Virus | Exposure to Hepatitis C virus | Exposure to HIV | High risk of Exposure to Hepatitis B Virus | High risk of Exposure to Hepatitis C virus | High risk of Exposure to HIV
Item
has a history of or is at high risk for recent exposure to hbv, hcv, or hiv;
boolean
C0332157 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0019682 (UMLS CUI [3,2])
C0332167 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0019169 (UMLS CUI [4,3])
C0332167 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0220847 (UMLS CUI [5,3])
C0332167 (UMLS CUI [6,1])
C0332157 (UMLS CUI [6,2])
C0019682 (UMLS CUI [6,3])
Autoimmune Disease
Item
has known history of autoimmune disease;
boolean
C0004364 (UMLS CUI [1])
Hypersensitivity Component Clinical Trial Vaccines
Item
has history of sensitivity to any component of study vaccines;
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Condition Interferes with Compliance | Exception Kidney Disease | Substance Use Disorder Interferes with Compliance | Condition Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results
Item
has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0022658 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
Chemotherapy | Chemotherapy Expected | Malignant Neoplasm | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
boolean
C0392920 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
Diabetic - poor control
Item
has uncontrolled diabetes;
boolean
C0421258 (UMLS CUI [1])
Kidney Transplantation Requirement Therapeutic immunosuppression
Item
has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
boolean
C0022671 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Blood product Received | Immunoglobulin Received | Requirement Blood Product Transfusion Probably
Item
has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
boolean
C0456388 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0005841 (UMLS CUI [3,2])
C0750492 (UMLS CUI [3,3])
Intravenous infusion of iron | Inactivated Vaccine Virus | Inactivated Vaccines Bacterial | Attenuated Live Virus Vaccine | Attenuated Bacteria Vaccine | CORTICOSTEROIDS FOR SYSTEMIC USE | Immunomodulators | Immunosuppressive Agents | Exception Inhaled steroids | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor | Investigational New Drugs
Item
has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (g-csf) or granulocyte-macrophage colony stimulating factor (gm-csf); any other investigational medicinal agent;
boolean
C4305398 (UMLS CUI [1])
C0042776 (UMLS CUI [2,1])
C0042212 (UMLS CUI [2,2])
C0042212 (UMLS CUI [3,1])
C0521009 (UMLS CUI [3,2])
C1516086 (UMLS CUI [4])
C1879753 (UMLS CUI [5])
C3653708 (UMLS CUI [6])
C1527392 (UMLS CUI [7])
C0021081 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C2065041 (UMLS CUI [9,2])
C0079459 (UMLS CUI [10])
C0079460 (UMLS CUI [11])
C0013230 (UMLS CUI [12])
Plasmid Injection | Oligonucleotide Injection | Hepatitis B Vaccines Investigational | Hepatitis B Vaccines Intradermal
Item
at any time: an injection of deoxyribonucleic acid (dna) plasmids or oligonucleotides; investigational or intradermal hepatitis b vaccine.
boolean
C0032136 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0028953 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C2240392 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C2240392 (UMLS CUI [4,1])
C1522475 (UMLS CUI [4,2])