Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

Inclusion Criteria

• Provide written informed consent prior to initiation of any study procedures,
• Are males or non-pregnant females between the ages of 18 and 45 years, inclusive,
• Women of childbearing potential in sexual relationships with men must use an acceptable method of preventing conception from 30 days prior to 3 months after Tice® BCG administration. Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or 0.35 IU/mL and 0.5 IU/ml,
• Have a urine dipstick for protein less than 1,
• Have a urine dipstick negative for glucose,
• Ability to understand and complete all study visits as required per protocol and be reachable by telephone.

Exclusion Criteria

• Have a history of suspected, confirmed, treated or have other evidence of active tuberculosis,
• Symptoms may include recurrent fever, fatigue, night sweats, weight loss, oral ulcers, diarrhea, nausea, vomiting, or bleeding,
• Have any systemic symptoms* within 72 hours before Tice® BCG administration or signs of lymphadenopathy, hepatosplenomegaly, or pulmonary disease by physical examination on day of Tice® BCG administration. Includes fever, chills, malaise, fatigue, headache, night sweats, weight loss, nausea, vomiting, bleeding, diarrhea, abdominal pain, rhinorrhea, cough, wheezing, or shortness of breath.
• Have history of any significant acute or chronic medical conditions* or need for chronic medications that, in the opinion of the investigator, will interfere with immunity or affect safety. Includes, but is not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions. Have any history of excessive scarring or keloid formation.
• Have household contact or occupation involving significant contact with someone who is immunocompromised. Includes persons with HIV, AIDs, or active cancer; infants (children 800 mcg/day of beclomethasone dipropionate or equivalent. If short term corticosteroids are given, then the subject should not receive Tice® BCG or have blood collected for immunogenicity studies within 1 week of steroid administration.
• Have immunosuppression or are taking systemic immunosuppressants as a result of an underlying illness or treatment,
• Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 36 months prior to Tice® BCG administration,
• Any active neoplastic disease,
• Have a pulse rate less than 50 bpm or greater than 100 bpm,
• Have a systolic blood pressure less than 90 mm Hg or greater than 140 mm Hg,
• Have a diastolic blood pressure less than 50 mm Hg or greater than 90 mmHg,
• Have a WBC less than 4.0x103/uL or greater than 10.5x103/uL,
• Have hemoglobin less than 11.5x103/uL (female) or less than 12.5x103/uL (male),
• Have a platelet count less than 140x103/UL,
• Have a creatinine greater than 1.30 mg/dL,
• Have an ALT (SGPT) greater than 40 IU/L (female) or greater than 55 IU/L (male),
• Have known HIV, Hepatitis B, or Hepatitis C infection,
• Have a history of alcohol or drug abuse in the last 5 years,
• Have had a positive PPD skin test in the past or received BCG vaccine (BCG vaccination history will be determined by self-report, country of birth, and/or evidence of BCG scar),
• Have a BMI >35,
• PPD skin test within 2 months prior to Tice® BCG administration or planned receipt during the study other than from participation in this study,
• Oral temperature ≥ 100.4°F (≥ 38.0°C) or other symptoms of an acute illness within 3 days before Tice® BCG administration. (Subject may be rescheduled),
• Any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation. Includes medical disease or condition that would place the subject at an unacceptable risk of injury, render them una