BCG Vaccination Delivered Intradermally, Orally and by Combined Routes

Who cannot join

• -Have a history of suspected or confirmed active tuberculosis (symptoms may include recurrent fever, fatigue, night sweats, weight loss, oral ulcers, diarrhea, nausea or vomiting, bleeding). -Have any systemic symptoms including fever, malaise, fatigue, chills, night sweats, weight loss, nausea, vomiting or bleeding, diarrhea, abdominal pain, rhinorrhea, cough, wheezing, or shortness of breath within 72 hr before vaccination or signs of mucosal ulceration, lymphadenitis, gastrointestinal, or pulmonary disease by physical examination on day of vaccination. -Note: Systemic symptoms occurring prior to secondary vaccination will result in the secondary vaccination being delayed until at least 72 hr after resolution of any of these symptoms that were not considered indicative of active tuberculosis (TB). -Have lymphadenopathy, hepatosplenomegaly, or other abnormalities on physical examination. -Have oropharyngeal or skin ulceration, or history of chronic/recurrent peptic ulcer disease or gastritis. -Note: Self-limited ulceration at intradermal (ID) vaccination site healing within 3 months or other mild to moderate complaints lasting less than 1-2 weeks, as documented in the memory aids (used for 2 weeks after each vaccination) or other source documents used to capture results of clinical assessments at any time point during the trial, will not be reasons to exclude a volunteer from receiving the secondary vaccination. -History of any significant acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions. -Have any history of scarring badly or keloid formation. -Have identifiable intermediate or high-risk behavior for HIV infection (defined as having had unprotected intercourse with multiple partners in the past year prior to enrollment, including men having sex with men). -Lives with someone with HIV, acquired immune deficiency syndrome (AIDS) or active cancer. -Have chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) -Have a history of smoking, alcoholism requiring medical attention, substance abuse, and/or intravenous drug use within the past 1 year prior to enrollment in the study. -Has a history or physical findings to suggest asthma or any chronic pulmonary condition. -Has a history of epilepsy. -Has a pacemaker or implantable cardiac devices. -Has a prosthetic valve. -Has a history of bleeding disorder. -Known allergy to any vaccine components. -Is currently taking anticoagulant or anti-platelet drugs and/or insulin. -Is currently under a physician's care for asthma or any chronic pulmonary condition. -Received blood products or immunoglobulin within 6 months of the first vaccination. -Vaccinated previously with Bacillus Calmette-Guérin (BCG) at study entry. -Received live attenuated vaccines within 4 weeks of vaccination. -Received inactivated vaccines within 2 weeks of vaccination. (Medically indicated inactivated vaccines should be given at least 2 weeks away from BCG immunization, or any sampling time point after vaccination.) -Participated in another research study that includes receiving an experimental agent or drug 30 days prior to vaccination. -Have a history of the use of a systemic antibiotic within the 14 days prior to vaccination or planned use of a systemic antibiotic during this study. -Have any medical, psychiatric, occupa tional, or behavioral problems that make it unlikely the volunteer will comply with the protocol as determined by the principal investigator (PI). -Be a health care provider at the highest risk of acquiring Mycobacterium tuberculosis (Mtb) infection, such as pulmonologists performing bronchoscopies on TB patients.