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.
Parallel
MTBVAC
Biological/VaccineVaccine Dose: MTBVAC 5x10\^5 Formulation (approximately, per standard dose): 3 - 17x10\^5 CFU Sucrose Sodium glutamate Presentation: Lyophilized pellet in vials (10 doses) Volume: 0.1 mL/dose Intradermal
Placebo
Biological/Vaccine0.9% saline Volume: 0.1 mL/dose Intradermal
To evaluate the protective efficacy of MTBVAC against bacteriologically confirmed PTB, not associated with HIV infection, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment, in baseline IGRA-positives.
Incident cases of definite pulmonary TB disease in baseline IGRA-positive participants with clinical suspicion of pulmonary TB disease, with Mtb identified by at least two positive diagnostic tests (two positive microbiological cultures or two positive Xpert MTB/RIF Ultra assays, or one positive of each) from sputum specimens taken before initiation of TB treatment and confirmed HIV-negative at the time of TB diagnosis, over a period starting 28 days following vaccination and lasting up to 36 months post vaccination.
To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment.
Incident cases of definite pulmonary TB disease in baseline IGRA-positive and IGRA-negative participants with clinical suspicion of pulmonary TB disease, with M.tb identified by at least two positive diagnostic tests (two positive microbiological cultures or two positive Xpert MTB/RIF Ultra assays, or one positive of each) from sputum specimens taken before initiation of TB treatment and confirmed HIV-negative at the time of TB diagnosis, over a period starting 28 days following vaccination and lasting up to 36 months post-vaccination.
To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo.
Incident cases of definite pulmonary TB disease in baseline IGRA-positive and IGRA-negative participants with clinical suspicion of pulmonary TB disease, with M.tb identified by microbiological culture or Xpert MTB/RIF Ultra from sputum specimens taken before initiation of TB treatment and confirmed HIV-negative at the time of TB diagnosis, over a period starting 28 days following vaccination and lasting up to 36 months post-vaccination.
To evaluate the protective efficacy of one dose of MTBVAC against definite Xpert MTB/RIF Ultra positive pulmonary TB disease not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo.
Incident cases of definite pulmonary TB disease in baseline IGRA-positive and IGRA-negative participants with clinical suspicion of pulmonary TB disease, with M.tb identified by Xpert MTB/RIF Ultra from sputum specimens taken before initiation of TB treatment and confirmed HIV-negative at the time of TB diagnosis, over a period starting 28 days following vaccination and lasting up to 36 months post-vaccination.
To evaluate the protective efficacy of one dose of MTBVAC against clinical TB, as compared to placebo, in the entire study population.
Incident cases of clinical TB disease in baseline IGRA-positive and IGRA-negative participants diagnosed by a clinician who has decided to treat the participant with TB treatment, over a period starting 28 days following vaccination and lasting up to 36 months post-vaccination.
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International AIDS Vaccine Initiative
Lead sponsor
Biofabri, SLU
Collaborator
Universidad de Zaragoza
Collaborator
