Tuberculosis (TB) is an infection caused by bacteria passed from one person to another through the air when an infected person for instance coughs, speaks, or sneezes. This study tests the safety and vaccine-induced immune response of a new preventive TB vaccine called H107e/CAF®10b. H107e is a copy of protein parts from the bacterium causing tuberculosis, Mycobacterium tuberculosis, which are also called antigens. CAF®10b is an adjuvant which helps the body discover the antigen. The adjuvant and antigen are mixed together to formulate the final vaccine. The final formulated vaccine enhances the immune system's response against the antigen. This is a first-in-human study, meaning this vaccine is being given to people for the first time. The primary objective is to evaluate the safety of the vaccine and its components; however, the study will also evaluate the specific immune responses generated by the new vaccine. The study is divided into two parts, phase 1a and phase 1b. Phase 1a investigates unadjuvanted H107e, CAF®10b adjuvant, H107e/CAF®10b vaccine (low adjuvant dose), and H107e/CAF®10b vaccine (full adjuvant dose). The trial products are administered twice intramuscularly. H107e is also administered intranasally in one of the groups on Day 85. Phase 1b investigates H107e/CAF®10b, H107e/CAF®10b+Bacillus Calmette-Guérin (BCG), BCG, and placebo. A placebo is a look-alike substance that contains no active drug. All groups in phase 1b receive H107e intranasally on Day 211. A preventive TB vaccine such as H107e/CAF®10b should be able to introduce the body's immune system to antigens from Mycobacterium tuberculosis. This will result in memory in the immune system, meaning that when a person gets infected with Mycobacterium tuberculosis, the immune system will recognise and target the bacteria to prevent disease, thereby avoiding the need for antibiotic treatment and/or other treatments and their side effects.
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Percentage of participants with solicited injection site reactions recorded up to seven days after each i.m. vaccination (phase 1a)
Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)
Percentage of participants with solicited systemic reactions recorded up to seven days after each i.m. vaccination (phase 1a)
Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)
Percentage of participants with unsolicited adverse events occurring up to 28 days after last i.m. vaccination (phase 1a)
Timeframe: Up to Day 57 (28 days after second dose)
Percentage of participants with adverse events of special interest occurring up to last visit (phase 1a)
Timeframe: Up to Day 197 (196 days after first dose)
Percentage of participants with serious adverse events (SAEs) occurring up to last visit (phase 1a)
Timeframe: Up to Day 197 (196 days after first dose)
Percentage of participants with solicited adverse events occurring up to seven days after i.n. mucosal recall (phase 1a)
Timeframe: Day 85 up to Day 92 (7 days after mucosal recall)
Percentage of participants with unsolicited adverse events occurring up to 28 days after i.n. mucosal recall (phase 1a)
Timeframe: Day 85 up to Day 113 (28 days after mucosal recall)
Percentage of participants with solicited injection site reactions recorded up to seven days after each vaccination (i.m. or i.d.) (phase 1b)
Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)
Percentage of participants with solicited systemic reactions recorded up to seven days after each vaccination (i.m. or i.d.) (phase 1b)
Timeframe: Up to Day 8 (7 days after first dose) and Day 29 up to Day 36 (7 days after second dose)
Percentage of participants with unsolicited adverse events occurring up to 28 days after last vaccination (phase 1b)
Timeframe: Up to Day 57 (28 days after second dose)
Percentage of participants with adverse events of special interest occurring up to last visit (phase 1b)
Timeframe: Up to Day 281 (280 days after first dose)
Percentage of participants with SAEs occurring up to last visit (phase 1b)
Timeframe: Up to Day 281 (280 days after first dose)
Percentage of participants with solicited adverse events occurring up to seven days after i.n. mucosal recall (phase 1b)
Timeframe: Day 211 up to Day 218 (7 days after mucosal recall)
Percentage of participants with unsolicited adverse events occurring up to 28 days after i.n. mucosal recall (phase 1b)
Timeframe: Day 211 up to Day 239 (28 days after mucosal recall)
Frequencies of H107e-specific CD4+ T-cells producing any combination of Th1 cytokines (IFN-γ, TNF, and/or IL-2) induced by H107e/CAF®10b vs. placebo and vs. H107e/CAF®10b + BCG before vaccination (Day 1) and 2 weeks after 2nd vaccination (phase 1b)
Timeframe: Day 1 and Day 43