The Horizon2020 research project TBVAC2020 aims to innovate and diversify the current TB vaccine (and biomarker) pipeline, while at the same time applying portfolio management using entry, gating and priority setting criteria to select as early as possible the most promising TB vaccine candidates and accelerate their development. The TBVAC2020 project builds on the highly successful and long-standing collaborations in subsequent EC-FP5-, FP6- and FP7-funded TB vaccine and biomarker projects, but also brings in a large number of new key partners from excellent laboratories from Europe, USA, Asia, Africa and Australia, many of which are global leaders in the TB field. Scientists and developers from 40 research partners collaborate in TBVAC2020. This 4-year project started in January 2015 and is coordinated by TBVI.
TBVAC2020 proposes to achieve this by combining creative ‘bottom-up’ approaches for vaccine discovery (Work Package 1: WP1), defining new preclinical models (WP2) and identifying correlates of protection (WP5). In a more directive ‘top-down’ approach portfolio management aims to select (and down-select) the most promising TB vaccine candidates by comparative evaluation using objective gating and priority setting criteria (WP6) and by supporting direct head-to-head or comparative preclinical and early clinical evaluation (WP3 preclinical, WP4 early clinical).
TBVAC2020 has the following 7 objectives:
- identification of a number of novel and diverse vaccine candidates ready for subsequent preclinical development and/or early clinical development, starting from about 20 novel and innovative discovery approaches;
- development of new preclinical models with greater relevance to the target product profile (TPP) and clinical vaccine efficacy, driven by 9 specific activities that aim at early comparative evaluation of new vaccine and biomarker candidates;
- direct comparative, head to head testing of vaccine candidates through selection and support of appropriate candidates for evaluation in standardised preclinical animal models, each addressing a different, specific read-out – Head to head testing in animal models;
- early development of up to 6 selected vaccine candidates through selection and support of specific preclinical activities – Preclinical development of new TB vaccine candidates;
- early clinical development of up to six selected TB vaccine candidates through selection and support of candidates for Phase I/first in man trials in standardised clinical trial facilities;
- identification, optimisation and evaluation of correlates of protection and TB disease through the support of around 15 innovative approaches;
- establishment of a more diverse and innovative portfolio of new TB vaccine candidates through a portfolio management approach, while aligning with and integrating into a global portfolio management approach to be established by the Global TB Vaccine Platform – Portfolio Management.
TBVI’s Product & Clinical Development Team (P&CDT), comprised of independent, top vaccine R&D experts, advises and guides the vaccine researchers and developers while they move their candidates from concept to clinical development.