Strategic Framework

The Global Plan to End TB 2016-2020 lays out a strategic framework for TB vaccines through the end of the decade. This framework is guided by the following principles:

  1. Increase focus on early-stage research to improve the variety of immunological strategies and approaches in the TB vaccine pipeline.
  2. Focus on adolescents and adults as an initial target population to have the most rapid impact on the epidemic, with the ultimate goal of developing vaccines that will be safe and effective in all populations—including children, people living with HIV, and the elderly.
  3. Develop vaccines for a number of uses to address the complexity of the human response to TB, including vaccines for people who have not yet been infected by TB (pre-exposure), and people who have been infected by the TB bacteria but have not developed TB disease (post-exposure). Vaccines are also being developed to shorten drug treatment for people with TB disease (immunotherapeutic vaccines).
  4. Explore new ways to vaccinate people, including needle-free delivery and vaccines that do not require refrigeration, to address barriers to vaccine delivery in resource-limited settings

New Vaccines Strategic Framework 2016–2020

Vision: To develop new, more effective vaccines that will directly and safely prevent TB in all age groups and populations
Goals:  Prevent TB disease and interrupt transmission through the development of new vaccines that would prevent infection, reactivation or reinfection; incorporate and consider access strategies throughout the TB vaccine development process; and strengthen community engagement in TB vaccine R&D.
Objective Milestone(s) Major Activities Funding Required 2016–2020 (US$ millions)
Continue to advance the clinical pipeline of TB vaccine candidates Advance candidate and candidate concepts through clinical trials, utilizing portfolio management and common stage-gating criteria Initiate at least one Phase III trial; and conduct Phase I/IIa/IIb trials on vaccine candidates that meet criteria


Explore and implement novel Phase II clinical trial designs to identify the most promising vaccines as early as possible in development and optimize use of resources Conduct trials using prevention of infection and prevention of recurrence study designs


Ensure sufficient capacity to support large-scale clinical trials  Scale up manufacturing to support large-scale (Phase IIb/III) clinical trials; maintain capacity trial sites in different regions to conduct clinical trials at GCP standards


Conduct epidemiological research at trial sites to inform site selection and trial design Conduct incidence and prevalence of TB infection studies; incidence of disease studies; and cross-sectional prevalence of disease studies in multiple regions


Total Objective 1 – Clinical pipeline  


Enhance knowledge through experimental medicine Develop and test a human challenge model to speed TB vaccine R&D Support consortium to advance human challenge model through development and preclinical phase, and initiate clinical phase


Complete human studies in parallel with NHP challenge in order to learn about protective immune responses Conduct NHP challenge studies to determine correlates of protective immunity


Test key hypotheses about protective immune responses Conduct multiple experimental medicine studies to test different hypotheses


Total Objective 2 – Experimental medicine  


Increase emphasis on early-stage and discovery research Develop biomarkers Identify immune correlates of protection and disease


Identify novel vaccine targets Identify and advance novel vaccine targets


Investigate new approaches to mount an effective response Conduct unconventional studies to induce protective immune responses


Total Objective 3 – Early-stage and discovery research


Improve animal models Develop and optimize fit for purpose animal models, including natural transmission models, and an optimal model to test prevention of infection or disease Enhance infrastructure; qualify and validate models in different animal species


Total Objective 4 – Animal models  


Improve preclinical and clinical readouts Standarize reagents and harmonize assays Gather stakeholder input and come to consensus on path forward


Continue and expand on programmes to provide reagents to laboratories and research facilities


Develop necessary assays based on stakeholder consensus


Total Objective 5 – Reagents and assays  


Lay the groundwork for adolescent and adult vaccination campaigns Conduct strategic access and implementation research, including studies of cost-of goods, TB cost–effectiveness, country vaccine readiness, and vaccine landscape


Total Objective 6 – Conduct strategic access research


Engage communities in TB vaccine R&D (see table below)


Grand Total


Strategic Framework for R&D Advocacy and Community Engagement

Objective Milestones Activities Funding Required 2016-2020 (millions)
Build support for TB vaccine R&D through an enhanced advocacy and community engagement framework Increase funding for TB R&D advocacy NGOs, community-based organizations, and other civil society and advocacy groups receive financial support for conducting advocacy at the global, regional, country, and local levels


Include advocates in decision-making structures and scientific forums TB research conferences and meetings take steps to enable the active participation of civil society and community representatives in program settings, including relevant tracks for abstract submission and funding to support participation.
Strengthen community engagement in research Clinical trials have community advisory/engagement plans and involve community representatives in the design, conduct and dissemination of research. Costing for community engagement for vaccine R&D is  included in the Strategic Frameworks

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