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

250

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

75

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

200

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

12

Total Objective 1 – Clinical pipeline  

537

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

20

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

100

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

100

Total Objective 2 – Experimental medicine  

220

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

60

Identify novel vaccine targets Identify and advance novel vaccine targets

40

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

100

Total Objective 3 – Early-stage and discovery research

200

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

150

Total Objective 4 – Animal models  

150

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

1

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

30

Develop necessary assays based on stakeholder consensus

40

Total Objective 5 – Reagents and assays  

71

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
 

12

Total Objective 6 – Conduct strategic access research

12

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

60

Grand Total

1250

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

60

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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