Tracks

Innovative approaches to basic, translational and preclinical research is essential to advance early-stage research and a robust preclinical pipeline, exploring diverse immunologic approaches, improved formulations and delivery platforms, preclinical research, and optimized animal models. 

A1. Mechanisms of biomarkers and protection
Studies combining pathogenesis and immunology; the role of non-conventional cellular, antibody, and innate immune responses; identifying biomarkers that correlate with vaccine-induced protection

A2. Novel approaches to vaccine discovery
Alternative immune responses; mucosal immune responses; protective antigen discovery 

A3. Improved formulations and delivery platforms
New routes of administration; experimental medicine to study outcomes of adjuvants, platforms, and the Mtb challenge strain; how vaccines can direct immune response to the lungs 

A4. Human challenge model/Controlled human infection model
Progress and advances in the development of human challenge/controlled human infection model 

A5. Preclinical development
Preclinical evaluation studies, immunogenicity studies, toxicology studies and other studies necessary that are necessary for regulatory submission and inform the field

A6. Optimizing animal models
Developing fit-for-purpose animal models; developing animal models that provide insight into the relation of Prevention of Infection and Prevention of Disease; developing animal models for specific human target populations; standardizing and harmonizing animal models; comparison of vaccine candidates within and across animal models.

Accelerating clinical development of new TB vaccines will require defining meaningful trial endpoints, improving the efficiency and standardization of TB vaccine trials, and ensuring sufficient clinical trial capacity, and meaningful community engagement. 

B1. Clinical trials
Clinical trials on candidates include key populations in clinical trials; inclusion of people living with HIV and other target populations in clinical trials and protocols 

B2. Trial site capacity
Assessments of current trial site capacity; epidemiology studies at potential trial sites; infrastructure and human capacity development and develop new, sustainable trial sites and capacity 

B3. Trial endpoints
Define standardized endpoints for Prevention of Disease and Prevention of Infection trials 

B4. Correlates of protection
Identifying and validating correlates of protection for TB disease 

B5. Trial harmonization and design
Efforts to harmonize clinical trial protocols; new models for TB vaccine trials

B6. Improved preclinical and clinical readouts
Standardizing reagents; harmonizing assays 

B7. Community engagement
Social science research on barriers to trial participation; community engagement in TB vaccine trials

To ensure that new TB vaccines will be adopted and rolled out in countries, key data and evidence must be gathered to support decision-making at country level and prepare for introduction and scale-up of new TB vaccines, and, as well as understanding health systems and barriers and enablers of vaccine uptake to ensure optimal implementation. 

C1. Demand assessments
Vaccine use cases; country-level demand modeling; health and economic impact in priority populations 

C2. Delivery systems
Infrastructure and supply chain; health system conditions for vaccine introduction; delivery methods for different populations 

C3. Vaccine value proposition
Assessments of value drivers for new TB vaccines among decision-makers; 

C4. Barriers and enablers of vaccine uptake
Social and behavioral research to understand perceptions of new vaccines; factors that will influence acceptability and uptake at individual and population levels; strategies to address concern 

C5. Post-licensure studies
Post-licensure studies of vaccine effectiveness, safety, and impact 

Successful implementation of new TB vaccines will require preparation, collaboration, and cooperation among multiple stakeholders to develop policy pathways, procurement plans, and strategies for implementation and sustained financing.  

D1. Policy Pathways
Regulatory approval and licensing; policy recommendations for implementation; pre-implementation research

D2. Procurement planning
Discussions between manufacturers, regulators, procurements partners; tech transfer and the role of local/regional manufacturers 

D3. Implementation strategies
Implementation strategies that consider priority and key populations and interactions between different care provider systems

D4. Sustainable financing
Strategies for financing vaccine procurement and in-country costs for delivery through national, international, and multilateral sources; innovative funding mechanisms 

D5. Engagement and communications strategies
Strategies to engage stakeholder groups in countries and to identify and address gaps in knowledge, awareness and perception of TB vaccines across the range of stakeholders who need to be engaged in the policy and implementation process.

Progress in TB vaccine R&D and ensuring public health impact will require enabling conditions, including increase funding, open science, and stakeholder and community engagement. 

E1. Funding
Approaches to broadening the funding base of traditional donors; innovative financing mechanisms; incentives for investment in early-stage development 

E2. Open science
Sharing of biospecimens collected in clinical studies; platforms for TB vaccine-related data sharing

E3. Political commitment
Approaches to building political will and commitments to new TB vaccines; accountability for meeting existing targets and commitments 

E4. Promote TB vaccine research literacy and advocacy
Community engagement and training programs; mechanisms for engaging community representatives in TB vaccine R&D; inclusion of community members in TB vaccine R&D forums; public engagement and information-sharing