Tuberculosis (TB) Clinical Trial
Official title:
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 Interferon Gamma Release Assay Positive Adolescents and Adults Aged 14-45 Years, Living in a TB Endemic Region.
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 interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region.
Phase 2b, double-blind, randomized, placebo-controlled, safety and efficacy study in 4,300 healthy adults and with a positive interferon gamma release assay (IGRA) test result. Most participants are likely to have received previous BCG vaccination in infancy. The investigational product is MTBVAC administered intradermally at 5x10^5 CFU. Participants meeting the enrolment criteria will be randomized in a 1:1 ratio to receive a single dose of MTBVAC or placebo administered intradermally on Study Day 1. Participants will be followed up for efficacy following vaccination via regular visits and contacts to screen for possible TB. Participants will also be trained to recognize signs and symptoms consistent with pulmonary TB disease and to report them for clinical evaluation. Participants with clinical presumption of pulmonary TB will be assessed with confirmatory diagnostic testing using a Nucleic Acid Amplification Test (Xpert MTB/RIF Ultra assay) and microbiological culture in sputum sampled on 3 separate days within a 1-week period. Participants diagnosed with pulmonary TB will be referred for TB treatment according to local clinical practice. Only HIV-negative participants will be eligible for enrolment. Participants will be tested for HIV seroconversion at the end of each year of follow-up and at the presumptive TB visits. Participants who test positive for HIV will be referred for TB preventive treatment and antiretroviral treatment according to local clinical practice. A sub-cohort of approximately 640 participants (320 in each study arm) will be selected for follow-up for solicited adverse events (AE) and selected chemistry and complete blood count (CBC). Additionally, a sub-cohort of approximately 430 participants (215 in each study arm) will be selected for specific immunogenicity assessments. The strategy for participant sub-cohort selection will be described in the Study Operations Manual (SOM). ;
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