A new TB vaccine R&D road map
The new Roadmap will be developed to define the activities required to deliver new TB vaccines and ensure their contribution to global public health, including clinical development priorities, key capacities required, and policy and access measures needed. The two-day meeting is part of a series of planned consultations with experts and key stakeholders to clarify and build consensus on the overall goals and challenges of TB vaccine development, knowledge gaps across the development pathway, and prioritisation as part of the road map design.
From the background information: “The Roadmap process is aligned with several other initiatives to stimulate effective R&D and public health uptake for new TB vaccines. The present meeting is also the logical next step in a series of consultations recently organized by the WHO to draft Preferred Product Characteristics for TB vaccines (October 2017), define the R&D pathway for the M72/AS01E candidate (July 2019) and develop a full public health value assessment of new TB vaccines (September 2019). The present meeting will build on these by taking the published Preferred Product Characteristics as the starting point.” It will integrate “needs and requirements for R&D along the entire chain from a product-agnostic perspective”.
Professor Peter Smith, Vice-Chair of the EDCTP Scientific Advisory Committee, will deliver the opening statement, EDCTP Strategic Partnerships Officer Ana Lúcia Weinberg will set the stage for the break-out sessions and TB vaccine Project Officer Dr Michelle Helinski will contribute to the discussions. The meeting is funded by EDCTP as part of its efforts to support TB-vaccine development. Currently, EDCTP is supporting several TB-vaccine studies:
- MTBVAC-Newborns – MTBVAC in Newborns: Phase 2a dose-defining safety and immunogenicity study and capacity building to support vaccine efficacy trials in tuberculosis-endemic regions of sub-Saharan Africa
(Grant identifier: RIA2016V-1637; Grant amount: EUR 5,537,093)
TBVI web page; EDCTP2 portfolio presentation
- POR TB – POR TB consortium: phase 2 trial to determine the efficacy of the multistage vaccine H56:IC31 for prevention of recurrent TB disease
(Grant identifier: RIA2016V-1631; Grant amount: EUR 13,788,161).
EDCTP2 portfolio presentation
- priMe – A multicentre phase III double-blind, randomised, controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG
(Grant identifier: Grant amount: EUR 12,492,521).
Project website; EDCTP2 portfolio presentation