Status and phase
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About
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Acute illness at the time of randomization
Oral temperature ≥37.5°C at the time of randomization
Clinically significant abnormal laboratory values for any of the following screening laboratory parameters, per local laboratory normal ranges from blood collected within 30 days prior to Study Day 0 randomization as follows:
Evidence of systemic or local disease process on screening urinalysis
Evidence of significant active infection
History of treatment for active or latent tuberculosis or evidence of active tuberculosis
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 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
Received a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to randomization.
Unable to discontinue current chronic prescription drug therapy that can be hepatotoxic or toxic to the bone marrow or kidneys.
History or laboratory evidence of immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection
History of allergic disease or reactions (including allergy to kanamycin-related antibiotics, allergic reaction to eggs, and severe eczema), likely to be exacerbated by any component of the study vaccine
Previous medical history that may compromise the safety of the participant in the study, including but not limited to: severe impairment of pulmonary function from pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy
Evidence of chronic hepatitis (e.g., hepatitis B surface antigen or hepatitis C antibody)
Chronic heavy ethanol intake which, in the opinion of the investigator, may compromise the safety of the participant or interfere with the evaluation of the safety of the vaccine
Cannabis smoking 3 or more days per week
Positive urine test for illicit drugs (opiates, cocaine, amphetamines)
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
All female participants: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening or on the day of study injection
Received a tuberculin skin test within 3 months (90 days) prior to Study Day 0
Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol or may compromise the safety of the participant
Primary purpose
Allocation
Interventional model
Masking
66 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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