Establishment, Strategy and Initial activities of the TuBerculosis Vaccine Initiative : Coordination of European efforts with global research initiatives

Projektinformationen

ESI-TBVI

ID Finanzhilfevereinbarung: 223064

Projekt abgeschlossen

Startdatum 1 Mai 2008

Enddatum 30 April 2010

Finanziert unter

• Specific Programme "Cooperation": Health

Gesamtkosten € 520 146,22

EU-Beitrag € 429 601,00

Koordiniert durch

ID-LELYSTAD, INSTITUUT VOOR DIERHOUDERIJ EN DIERGEZONDHEID B.V.
Netherlands

Final Report Summary - ESI-TBVI (Establishment, strategy and initial activities of the tuberculosis vaccine initiative: coordination of European efforts with global research initiatives)

'Tuberculosis vaccine initiative' (TBVI) was established as a not for profit, private foundation in 2008. More than 40 TBVI partners are supported in a portfolio of two programs for vaccine development, one program for biomarkers and one program for infrastructure support activities. These programs are managed by a TBVI steering committee (SC) composed of 12 leading TB vaccine experts. Product and clinical development teams (PDT and CDT) guide the advancement of each product and provide feedback to the SC.

A board of trustees (BOT) is composed of representatives of donor organisations supporting TBVI, and of independent individuals acting as high representatives. The BOT advises the SC on strategic issues and approves the overall TBVI budget. The governance board (GB) is composed of two directors of Wageningen UR, and the chairs of the SC and BOT. The GB verifies process and financial resources of allocated project funds, and appoints members of operational office, SC and BOT. An operational office (OO) supports the SC, BOT and GB in their tasks by preparing project proposals, providing project management expertise, executing advocacy and resource mobilisation activities. Further information can be obtained in the annual report and the website of TBVI (see http://www.tbvi.eu online).

TBVI SC has compiled a position paper that delineates the TBVI strategy for R&D and for advocacy and resource mobilisation for the period 2009-2018. A 'popular' version of the latest version of our strategy can be found on our website. The strategic plan proposes support a portfolio of two vaccine programmes, one biomarker programme, and one programme for clinical trials capacity building.

One vaccine programme contains 18 vaccine developments to boost the current BCG vaccine (in various age groups) and aims to have 5 of these advanced to phase II clinical trial stages between 2009-2020. The second vaccine programme contains 19 priming vaccines that could replace BCG and be safe in HIV individuals, and aims of having 3 of these advanced to phase II clinical stages between 2009-2020. The biomarker programme holds a portfolio of 30 biomarkers and aims to have 3 tests for monitoring clinical trials available between 2015-2020. The clinical trials capacity programme aims to support 1-3 existing sites to enable execution of phase I/II TB vaccine trials.

To support this R&D plan, TBVI aims to raise 200 mE in the coming 10 years. In Europe, meetings with many European parliament members, country parliament members, and government officials in France, Germany, Sweden, Finland, UK, Spain, Belgium, the Netherlands, and Hungary have occurred and created awareness about TB and the efforts of TBVI towards development of new TB vaccines. Resource mobilisation activities have led to a USD 3 million grant from the Bill & Melinda Gates Foundation for our advocacy and fundraising activities, and the approval of a new EC FP7, collaborative project proposal, NEWTBVAC (EUR 12 million). NEWTBVAC aims to continue and innovate the translational vaccine and biomarker activities of the TBVAC project that ends 31 December 2009.

To enable global coordination of TB vaccine development, TBVI OO and SC members are actively participating in various committees of the STOP-TB partnership (vaccines section). Concrete activities resulting from these interactions are the second live TB vaccine meeting in Geneva in April 2009 (co-sponsored by STOP-TB, TBVI and Aeras), and co-sponsoring of an awareness reception and contributions to the vaccine sessions during the IULTD meetings in Paris (October, 2008), and Cancun (December, 2009). A meeting on potential development of functional assays was organised in 2007 in Geneva by the subcommittee clinical assays of STOP-TB (Chair: Prof. Paul-Henri Lambert). For coordination purposes, Aeras and TBVI have signed a memorandum of understanding for cooperation and collaboration in the field of TB vaccine development.