Clinical trial: Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers (NCT01599897)

Eligibility criteria:
Inclusion Criteria:

          -  Has completed the written informed consent process prior to start of screening
             evaluations

          -  Male or female who is 18 to 45 years of age at the time of randomization

          -  Agrees to stay in contact with the study site for the duration of the study, provide
             updated contact information as necessary, and has no current plans to move from the
             study area for the duration of the study

          -  Agrees to avoid elective surgery for the full duration of the study

          -  For female subjects: agrees to avoid pregnancy through Study Day 238. Women physically
             capable of pregnancy (not sterilized and still menstruating or within 1 year of the
             last menses if menopausal) in sexual relationships with men must use an acceptable
             method of avoiding pregnancy during this period. Acceptable methods of avoiding
             pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual
             intercourse), hormonal contraceptives (oral, injection, transdermal patch, or
             implant), vaginal ring, intrauterine device (IUD), condoms or the combination of
             diaphragm with spermicide

          -  Has body mass index (BMI) between 19 and 33 (weight/height2) by nomogram at the time
             of randomization

        Exclusion Criteria:

          -  Acute illness at the time of randomization

          -  Oral temperature greater than 37.5C (99.5F) at the time of randomization

          -  Values for any of the following screening laboratory parameters, from blood collected
             within 15 days prior to randomization, outside the normal ranges per local laboratory
             parameters: hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte
             count, white blood cell count, electrolytes, ALT, AST, total bilirubin, alkaline
             phosphatase (ALP), creatinine, BUN, and lipid profile

          -  Evidence of systemic or local disease process on screening urinalysis

          -  Evidence of significant active infection

          -  Positive laboratory test (e.g., QuantiFERON(R)-TB) evidence of Mtb infection at
             screening

          -  History of treatment for active or latent tuberculosis infection

          -  History or evidence of active tuberculosis

          -  Has received vaccination or immunotherapy with a BCG product at any time prior to
             randomization

          -  Shared a residence within the last year prior to randomization with an individual on
             anti-tuberculosis treatment or with culture or smear positive tuberculosis

          -  History of or evidence of current hypertension

          -  History of autoimmune disease or immunosuppression

          -  Used immunosuppressive medication within 42 days before randomization (inhaled and
             topical corticosteroids are permitted)

          -  Received immunoglobulin or blood products within 42 days before randomization

          -  Received any investigational drug therapy or investigational vaccine within 182 days
             before randomization, or planned participation in any other investigational study
             during the study period

          -  Received investigational Mtb vaccine at any time prior to randomization

          -  Unable to discontinue current chronic prescription drug therapy including hormone
             replacement such as thyroxin, insulin, and medications that can be hepatotoxic or
             toxic to the bone marrow (such as statins) etc (estrogen and progesterone replacement
             and contraceptives, topical medications, and nasal steroids are acceptable)

          -  History or laboratory evidence of immunodeficiency state including but not limited to
             laboratory indication of HIV 1 infection at screening

          -  History of allergic disease or reactions (such as an allergic reaction to eggs),
             including eczema, likely to be exacerbated by any component of the study vaccine

          -  History of allergic reaction to kanamycin-related antibiotics

          -  Previous medical history that may compromise the safety of the subject in the study,
             including but not limited to: severe impairment of pulmonary function from
             tuberculosis infection or other pulmonary disease; chronic illness with signs of
             cardiac or renal failure; suspected progressive neurological disease; or uncontrolled
             epilepsy or infantile spasms

          -  History of positive tuberculin skin test

          -  Evidence of chronic hepatitis (e.g., hepatitis B core antibody or hepatitis C
             antibody) at screening

          -  History of alcohol or drug abuse within the past 2 years or consumes more than 1
             (women) or 2 (men) alcoholic beverage(s) per day

          -  Tobacco or cannabis smoking 3 or more days per week

          -  History of keloid formation

          -  Positive urine test for illicit drugs (opiates, cocaine, amphetamines) at screening

          -  History or evidence on physical examination of any systemic disease or any acute or
             chronic illness that, in the opinion of the investigator, may interfere with the
             evaluation of the safety or immunogenicity of the vaccine, including axillary
             lymphadenopathy

          -  All female subjects: currently pregnant or lactating/nursing; or positive urine
             pregnancy test during screening or positive urine pregnancy test on the day of study
             injection

          -  Received a tuberculin skin test within 3 months (90 days) prior to the time of
             randomization

          -  Any current medical, psychiatric, occupational, or substance abuse problems that, in
             the opinion of the investigator, will make it unlikely that the subject will comply
             with the protocol
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment