Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial.
Sara A SulimanAngelique Kany Kany LuabeyaHennie GeldenhuysMichele TamerisSoren T HoffZhongkai ShiDereck TaitIngrid KromannMorten RuhwaldKathryn Tucker RutkowskiBarbara ShepherdDavid HokeyAnn M GinsbergWillem A HanekomPeter AndersenThomas Jens ScribaMark Hatherillnull nullPublished in: American journal of respiratory and critical care medicine (2019)
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 M.tb-uninfected adults. Additional studies should validate applicability of vaccine doses and regimens to both QFT-positive and QFT-negative individuals. Clinical trial registered with www.clinicaltrials.gov (NCT01865487).
Keyphrases
- clinical trial
- mycobacterium tuberculosis
- double blind
- placebo controlled
- phase ii
- phase iii
- study protocol
- open label
- hiv infected
- randomized controlled trial
- squamous cell carcinoma
- high glucose
- emergency department
- diabetic rats
- oxidative stress
- hepatitis c virus
- drug induced
- case control
- human immunodeficiency virus