Emergent BioSolutions Release: New TB Vaccine Candidate Enters Phase IIb Proof-of-Concept Trial in South Africa

OXFORD, England, ROCKVILLE, Md. & CAPE TOWN, South Africa--(BUSINESS WIRE)--The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd. (“the Consortium”), Isis Innovation Ltd., the Wellcome Trust and the University of Cape Town (UCT) announce today the start of a Phase IIb proof-of-concept clinical trial of a promising new TB vaccine developed at the University of Oxford called MVA85A/AERAS-485. The study will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) of UCT in the Western Cape Region from its study site 100 km from Cape Town in Worcester, South Africa. This study, which has been approved by the Medicines Control Council of South Africa, will test MVA85A/AERAS-485 in approximately 2,784 children under one year of age, all of whom have received Bacille Calmette-Guerin (BCG) at birth. It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate. This is the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.
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