HIV Seropositivity
Item
documented hiv+
boolean
C0019699 (UMLS CUI [1])
Age
Item
age 12 to < 25 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis B vaccination
Item
history of no or one hepatitis b vaccination
boolean
C0474232 (UMLS CUI [1])
Pregnancy
Item
not pregnant.
boolean
C0032961 (UMLS CUI [1])
Gender Sex Behavior Contraceptive methods
Item
females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Hepatitis B vaccination Quantity
Item
history of > 1 hepatitis b vaccination
boolean
C0474232 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hepatitis B Evidence Serologic | Hepatitis B Virus Surface Antibody | Hepatitis B Surface Antigens | Antibody to hepatitis B core antigen
Item
serologic evidence of past or present hepatitis b infection: anti-hepatitis b surface antigen (hbsag), hbs-ag or anti- hepatitis b core antigen (hbcag)
boolean
C0019163 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0369334 (UMLS CUI [2])
C0019168 (UMLS CUI [3])
C0312631 (UMLS CUI [4])
Allergic Reaction Hepatitis A immunization | Allergic Reaction Hepatitis B vaccination | Allergic Reaction Yeasts | Allergic Reaction Thimerosal | Allergic Reaction Aluminum
Item
previous allergic reaction to hepatitis a or b vaccinations or to yeast, thimerosal or aluminum.
boolean
C1527304 (UMLS CUI [1,1])
C0419735 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0474232 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0043393 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0039867 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0002367 (UMLS CUI [5,2])
Opportunistic Infections | Therapeutic procedure Bacterial Infections Serious
Item
active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
boolean
C0029118 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0004623 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Toxicity Grade
Item
presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
boolean
C2826262 (UMLS CUI [1])
Steroid therapy Long-term anticipation | Anti-Inflammatory Agents, Non-Steroidal | inhaled steroids | Topical corticosteroids
Item
anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
boolean
C0149783 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0679106 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0304604 (UMLS CUI [4])
Pharmaceutical Preparations Restricted
Item
receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
boolean
C0013227 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Immunoglobulins | Human plasma, blood product
Item
receipt of immune globulin product or plasma product within 6 months preceding randomization
boolean
C0021027 (UMLS CUI [1])
C0304926 (UMLS CUI [2])
Blood product Licensed | Transfusion | Vaccine Licensed
Item
receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
boolean
C0456388 (UMLS CUI [1,1])
C0023636 (UMLS CUI [1,2])
C0005841 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C0023636 (UMLS CUI [3,2])
Immune System Diseases | HIV | Therapeutic procedure Malignant Neoplasms
Item
known or suspected diseases of the immune system, other than hiv, or treatment for a malignancy within 3 months of randomization.
boolean
C0021053 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Other medical condition | Surgical aspects
Item
other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
boolean
C3843040 (UMLS CUI [1])
C0038895 (UMLS CUI [2])