Working Group on New Vaccines

1. Working Group on New Vaccines

2. Purpose of the Working Group on New Vaccines • Facilitate the development of new, more effective TB vaccine by promoting collaboration and coordination amongst multiple stakeholders • Support the objectives for new vaccines as outlined in the Global Plan to Stop TB • Serve as the mechanism of exchange and dialogue between the Stop TB Partnership and the research community • Provides a forum to discuss challenges to TB vaccine development and identify solutions, and to build consensus on key issues and questions.

3. Constituency-Based Group Chair: Michel Greco Private Sector/Industry Didier Lapierre, GSK Biologicals WHO Uli Fruth, Initiative for Vaccine Research (Secretariat) Christian Lienhardt, Stop TB Department Aeras (standing member) Mike Brennan Ann Ginsberg, (alternate) Jennifer Woolley (co-Secretariat) TBVI (standing member) Jelle Thole Field Sites • Willem Hanekom, South African Tuberculosis Vaccine Initiative Academic Institutions • Dave Lewinsohn, Oregon Health Sciences University (participation supported by American Thoracic Society) Philanthropic Funders • Peggy Johnston, Bill & Melinda Gates Foundation Public Sector Funders • Christine Sizemore, NIAID/NIH Affected Communities Lucy Ghati, Kenya Robert Nakibumba, Uganda

4. Vaccines Working Group:Contributions to Global Plan Objectives Objective 1: To maintain a robust TB vaccine pipeline by supporting research and discovery • Convened biannual “out of the box” innovation workshops to bring together experts in the fields of immunology and vaccinology across disease areas to inform and stimulate new approaches to TB vaccine R&D. Objective 2: To conduct research to identify correlates of protection and preclinical studies to assess new TB vaccine candidates • Coordinated a two year study on the development of Mycobacterial Growth Inhibition Assays as a biomarker for use in human clinical studies of TB vaccines, resulting in a final analysis and identification of a functional assay that will be standardized across field sites. Objective 3: Ensure availability of vaccine production capacity by expanding manufacturing facilities for TB vaccines. • The Working Group on New TB Vaccines does not have specific activities related to this objective, although several of its partners are becoming more engaged in this work.

5. Vaccines Working Group:Contributions to Global Plan Objectives Objective 4: To build capacity and lay the groundwork for large-scale clinical trials (Phase II and Phase III) of TB vaccine candidates at field sites in TB endemic countries • Provided support to TBVACSIN (network of clinical trial sites) to strengthen South-South collaboration and to allow field sites that are currently or will be conducting clinical trials to share information, resources, and lessons learned. Objective 5: To conduct phase I, II and III clinical trials of TB vaccine candidates • Convened clinicians, researchers, product developers and other stakeholders to develop a consensus on clinical endpoints. A consensus statement on clinical endpoints in infants has been developed and published. • Discussions on consensus on clinical endpoints in adolescent and adult populations have been initiated.

6. Vaccines Working Group:Contributions to Global Plan Objectives Objective 6: Develop delivery, regulatory and access strategies for new TB vaccines • Engaged with SAGE through a presentation and discussion at November 2011 meeting. A report tracking progress will be submitted annually at the request of SAGE • Developed a Technical Expert Group to provide advice and guidance and to help guide new TB vaccines through the SAGE process • Continued engagement with AVAREF and DCVRN to strengthen regulatory capacity on issues specific to TB vaccines Objective 7: Build support for TB vaccine development and uptake through advocacy, communications and resource mobilization • Supported active participation of community representatives in the Union Conference and regional forums • Provided support for community representatives to visit TB vaccine field sites to inform their work • Developing new materials targeted towards affected communities and advocates

7. Global Forum on TB Vaccines First Global Forum on TB Vaccines (2001, Geneva) • Concluded that the “driving force” for identifying improved vaccines for tuberculosis over the next ten years would be moving investigational TB vaccines into human clinical trials.  • A few dozen participants Second Global Form on TB Vaccines (2010, Tallinn) • Reviewed progress in the TB vaccine field over the last decade • Identified priorities for the next decade and initiated the consultative process to develop Blueprint for TB Vaccine Development • 200 participants from 31 countries Third Global Forum on TB Vaccines (2013, Cape Town) • Progress against Blueprint will be tracked and the future of TB vaccine R&D will be discussed • Increasing number of sessions on critical issues including access, advocacy, and sustainability of the pipeline

8. Tuberculosis Vaccines:A Strategic Blueprint • Comprehensive strategy to coordinate and catalyze TB vaccine development through partnership, innovative strategies and creative mechanisms. • Developed through a consultative process initiated at 2nd Global Forum on TB Vaccines (Estonia, Sept 2010) • Published in Tuberculosis (open access); developed collateral materials for non-research audiences • Launched at World TB Day event in Brussels and media event in Johannesburg in March 2012 • Addresses critical challenges and questions and serves to guide the next decade of TB vaccine R&D • Progress against Blueprint will be assessed at 3rd Global Forum on TB Vaccines (March 2013)

9. Looking Ahead: 2013-2015 • Implement Technical Expert Group to provide guidance on regulatory and policy issues • Continue engagement with international and national regulatory authorities • Provide a platform for the TB vaccine research community to contribute to the post-2015 Stop TB Strategy and other global initiatives • Expand efforts to engage civil society and affected communities, and to broaden the base of support for TB vaccine R&D • Support and facilitate continued discussion on clinical endpoints in adolescent and adult vaccine trials • Increase focus on access and sustainability issues • Monitor progress against key challenges and issues outlined in the Blueprint