A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.
Is male or female aged 14 through 45 years on Study Day 1.
Has completed the written (or thumb printed and witnessed) informed consent process (participants older than 18 years) or has completed the written parental consent and participant assent process (participants younger than 18 years) before any study-related procedures were performed.
Participants who, in the opinion of the investigatory, can and will comply with the requirements of the protocol (e.g., to stay in contact with the Clinical Research Centre (CRC), return for follow-up visits)
Has general good health as confirmed by medical history and physical examination.
Acute illness and/or axillary temperature ≥37.5°C on Study Day 1.
Current suspicion or evidence (including but not limited to sputum Xpert MTB/RIF positive) of active TB disease at any CRC. An attempt must be made to obtain sputum from each participant; persons who are sputum unproductive will be assumed to be Xpert MTB/RIF negative.
History of previous TB disease and/or treatment for TB disease.
History of TB preventative therapy, not including BCG vaccination.
International AIDS Vaccine Initiative
Lead sponsor
Biofabri, SLU
Collaborator
Universidad de Zaragoza
Collaborator