EC investments in TB vaccine Research and Development through TBVI and its R&D partners have resulted in 6 TB vaccines currently being evaluated in clinical trials making up almost 50% of the vaccine candidates of current global clinical pipeline for TB vaccines – a pipeline that was virtually empty 15 years ago. These investments have strengthened European excellence and leadership in the TB vaccine R&D arena. A key factor in producing these results has been the effective partnership among TBVI and its R&D partners that focuses on knowledge development and early data sharing. The recent TBVI annual meeting (including the TBVAC2020 meeting and the TBVI symposium) in Les Diablerets, Switzerland, from Februari 2-5 2016 was another demonstration of this effective partnership in action.
For 5 days, 167 participants from 18 countries within the EU as well as from outside, and representing 58 research institutes, universities, industries, SMEs, funding agencies, technical agencies and partner organisations, shared their latest results and achievements from the EC funded TBVAC2020 project.
The meeting also brought together TBVAC2020 consortium members with those of other initiatives such as the CTVD (Collaboration for TB Vaccine Discovery from the Bill and Melinda Gates Foundation) and EMI-TB (Eliciting Mucosal Immunity in Tuberculosis, another EU H2020 project on TB vaccines). Each and all shared information on progress and perspectives of ongoing activities in their respective projects.
The week also featured the annual TBVI symposium entitled ‘TB vaccines and immunity’. The symposium focused on unconventional immunity, featuring many exciting new insights into human MAIT cells, HLA-E restricted T cells and (BCG trained) innate immunity in TB and following vaccination. A session on Viral Vectors & Respiratory Immunity showed the possibility of using lentiviral vectors as a potent and promising vaccine delivery platform, highlighted new insights in pulmonary TB vaccination strategies and in mucosal immunity induced by such strategies. A third session presented an update on 5 leading TB vaccine candidates in the TB clinical pipeline.
The TBVAC2020 project meeting provided the first results of R&D activities, including vaccine discovery, preclinical model development, preclinical development of TB vaccine candidates, clinical evaluation of TB vaccine candidates, and biomarkers of immunity and protection. During the vaccine discovery session updates were provided on novel subunits as potential vaccine candidates and on genetically engineered live mycobacterial candidates including attenuated M. tuberculosis mutants, and new delivery strategies – new adjuvants, mucosal prime-boost models, adenoviral vector systems – were presented. Model development and refinement efforts and head-to-head vaccine candidate evaluation in various standardized animal models were reported. The latest findings on preclinical stage candidates, including HBHA, BCG Δzmp1, and PPE15 based candidates, was presented in specific preclinical sessions. Developments on the design and selection of candidate TB vaccines for an upcoming comparative clinical Phase I evaluation were presented. Partners in the establishment of global portfolio advisory committee expounded on stage gating and priority setting strategies to support the global effort towards the development of improved TB vaccine regimen. During the correlates of protection session promising diagnostic biomarkers were presented with the potential to discriminate active TB from latently infected individuals, as well as promising correlates of risk of developing TB. These markers/correlates shall allow for targeted interventions and risk stratification of cohorts for clinical studies.
The Executive Director TBVI and the Chair of the TBVAC2020 project were pleased to announce during the meeting that two new industry partners, GSK and Transgene SA, are joining the TBVAC2020 consortium. GSK will bring its combination vaccines for prime-boost or co-administration strategies into the project, while Transgene will provide to the consortium its prophylactic/ therapeutic vaccine candidate based on MVA delivery of multiple Mtb antigens covering specific metabolic states during infection (active replication, dormancy, resuscitation). GSK and Transgene SA bring complementary expertise and add another dynamic to the consortium, contributing to the diversification of new vaccine candidates through the vaccine pipeline.