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:

  1. 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;
  2. 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;
  3. 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;
  4. early development of up to 6 selected vaccine candidates through selection and support of specific preclinical activities –  Preclinical development of new TB vaccine candidates;
  5. 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;
  6. identification, optimisation and evaluation of correlates of protection and TB disease through the support of around 15 innovative approaches;
  7. 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.

WP 1: Vaccine discovery

Overall objectives: To identify new and diverse approaches and platforms for TB vaccination ready for subsequent preclinical and/or early clinical development through support of around 20 novel and innovative discovery approaches.
This WP is subdivided into 3 specific subWP’s as follows:
WP1.1: Antigen Discovery
WP1.2: New Delivery Systems & Immunisation Strategies
WP1.3: Novel Live Vaccines

WP 2: Preclinical model development

Overall objectives: To develop improved and more diverse model systems with greater relevance to target product profiles (TP) to eventually support preclinical development (WP3) and (global) candidate portfolio management (WP6). Investigation of fundamental aspects of TB infection and immunity under various conditions as well as banking of biomaterials from these animal studies shall contribute to biomarker identification/validation (WP5).

WP 3: Preclinical evaluation and vaccine development

Overall objectives: To accelerate the preclinical development of specific vaccine candidates, and to evaluate in head-to-head testing selected candidates for aspects of safety, immunogenicity and/or protective efficacy to support the pre-clinical development activities of the project and to assist in portfolio management using predefined, objective gating and priority setting criteria (WP6).
This WP is subdivided into 2 specific subWP’s as follows:
WP3.1: Head-to-Head Testing in Animal Models
WP3.2: Preclinical Development of New Candidates

WP 4: Early clinical vaccine development

Overall objectives: To accelerate early clinical development of (early clinical) TB vaccine candidates through selection and support for Phase I/first-in-man trials using highly standardised operation procedures and in standardised clinical trial facilities.

WP 5: Correlates of protection

Overall objectives: To identify, test, evaluate and prioritise surrogate-endpoints of protection in human TB, and to develop further tests to measure these.

WP 6: Portfolio management

Overall objectives: To establish a diverse and innovative portfolio of new TB vaccine candidates through a portfolio management approach prioritising candidates for head-to-head preclinical testing (WP3.1), for support for preclinical development (WP3.2) or for support for early clinical testing (WP4), and to align and integrate into a global portfolio management approach to be established by a GTBVP.

EuropeanCommission

This project receives financial support from the European Commission’s Horizon 2020 research and innovation programme under grant agreement No 643381.