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Dose Optimization of H56:IC31 Vaccine for TB Endemic Populations: A Double-Blind, Placebo-Controlled, Dose-Selection Trial.

BACKGROUND: Global tuberculosis (TB) control requires effective vaccines in TB-endemic countries, where most adults are infected with Mycobacterium tuberculosis (M.tb). We aimed to define optimal dose and schedule of H56:IC31, an experimental TB vaccine comprising Ag85B, ESAT-6, and Rv2660c, for M.tb-infected and uninfected adults.

METHODS: We enrolled 98 healthy, HIV-uninfected, BCG-vaccinated, South African adults. M.tb infection was defined by QuantiFERON (QFT) assay. QFT-negative participants received two vaccinations of different concentrations of H56 in 500nmol of IC31® to enable dose selection for further vaccine development. Subsequently, QFT-positive and negative participants were randomized to receive two or three vaccinations to compare potential schedules. Participants were followed for safety and immunogenicity for 292 days.

RESULTS: H56:IC31 showed acceptable reactogenicity profiles irrespective of dose, number of vaccinations, or M.tb infection. No vaccine-related severe or serious adverse events were observed. The three H56 concentrations tested induced equivalent frequencies and functional profiles of antigen-specific CD4 T cells. ESAT-6 was only immunogenic in QFT-negative participants who received three vaccinations.

CONCLUSIONS: Two or three H56:IC31 vaccinations at the lowest dose induced durable antigen-specific CD4 T cell responses with acceptable safety and tolerability profiles in M.tb-infected and uninfected adults. Additional studies should validate applicability of vaccine doses and regimens to both QFT-positive and negative individuals. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01865487.

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