New TB vaccines under development

In recent years several promising new TB vaccine candidates have been developed. The FP6 TB VAC programme (funded by EU) aims to integrate the European efforts towards the development of novel tuberculosis vaccine candidates and forward these vaccines to small scale, Phase I human clinical trials in Europe and in Africa. The leading vaccine candidates within the TBVAC include the MVA85A (recombinant viral vector vaccine), Hybrid 1-IC, Mtb72F/ AS02A (protein subunit vaccine with new adjuvant), live rBCG:ureC:Hly (recombinant BCG vaccine) and live attenuated M. tuberculosis (PhoP mutant) vaccine.

Research and Advisory in NIBSC (activities are funded by EU FrameWork VI (2004 – 2009) grant) and FrameWork VII (commencing 2010).

• As part of EU TB Vaccine Consortium (and TB Vaccine Initiative from 2010) working on the development of new TB vaccines
• Provide regulatory advice and recommendations on vaccine safety, quality and characterisation to vaccine developers and manufacturers
• Facilitate and assist vaccine developers throughout the clinical development process to bring vaccine candidates to Phase I clinical trial studies
• Establish laboratory assays for new TB vaccines characterisation and for quality control purposes
• Undertake basic research to underpin quality safety and efficacy studies of tuberculosis vaccines within a regulatory framework.
• Establish guidelines and principles for harmonisation of immune assays used in clinical trials of TB vaccines