The prestigious magazine Plos One has just published the article “Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection”, which summarizes the results obtained in the Phase II study carried out in three sites in South Africa (Bloemfontein, George and Port Elizabeth), between July 2010 and April 2011.
The article, signed by Andre S. Nell,1 Eva D’lom,2 Patrick Bouic,3 Montserrat Sabaté,4 Ramon Bosser,5 Jordi Picas,6 Mercè Amat,6 Gavin Churchyard,7 i Pere-Joan Cardona6,8, comes to the conclusion that this Phase II clinical trial demonstrates reasonable tolerability of RUTI®. The immunogenicity profile of RUTI® vaccine in LTBI subjects, even being variable among groups, allows considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase.
1 PAREXEL Early Phase Clinical Unit, Bloemfontein, South Africa
2 PAREXEL International, Madrid, Spain
3 Synexa Life Sciences, Cape Town, South Africa
4 TFS Develop, Barcelona, Catalonia, Spain
5 Janus Developments, Barcelona, Catalonia, Spain
6 Archivel Farma, Badalona, Catalonia, Spain
7 The Aurum Institute, Johannesburg, South Africa
8 Unitat de Tuberculosi Experimental (UTE), Institut per a la Investigació en Ciències de la Salut Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain
The study was carried out by three South African sites (Bloemfontein, George and Port Elizabeth) from July 2010 to April 2011