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

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.
PMID: 30092143 [PubMed - as supplied by publisher]

Source: American Journal of Respiratory and Critical Care Medicine - August 9, 2018 Category: Respiratory Medicine Authors: Suliman S, Luabeya AKK, Geldenhuys H, Tameris M, Hoff ST, Shi Z, Tait D, Kromann I, Ruhwald M, Rutkowski KT, Shepherd B, Hokey D, Ginsberg AM, Hanekom WA, Andersen P, Scriba TJ, Hatherill M, H56-035 Trial Group Tags: Am J Respir Crit Care Med Source Type: research