Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial

Publication date: Available online 12 August 2019Source: The Lancet Respiratory MedicineAuthor(s): Michele Tameris, Helen Mearns, Adam Penn-Nicholson, Yolande Gregg, Nicole Bilek, Simbarashe Mabwe, Hennie Geldenhuys, Justin Shenje, Angelique Kany Kany Luabeya, Ingrid Murillo, Juana Doce, Nacho Aguilo, Dessislava Marinova, Eugenia Puentes, Esteban Rodríguez, Jesús Gonzalo-Asensio, Bernard Fritzell, Jelle Thole, Carlos Martin, Thomas J ScribaSummaryBackgroundInfants are a key target population for new tuberculosis vaccines. We assessed the safety and immunogenicity of the live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC in adults and infants in a region where transmission of tuberculosis is very high.MethodsWe did a randomised, double-blind, BCG-controlled, dose-escalation trial at the South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa. Healthy adult community volunteers who were aged 18–50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-γ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort. Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort. El...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research