Tracks

A1. Mechanisms of biomarkers and protection

• Studies combining pathogenesis and immunology to identify components of the host-pathogen interaction associated with clearance, progression to disease and subclinical disease
• Utilization of biospecimens and analysis of data gathered in clinical trials to validate correlates of protection
• Studies to identify biomarkers and biosignatures of natural and vaccine-induced protection
• Research to study the role of non-conventional cellular immunity (e.g. Class-I-restricted CD8+ T-cells, TH17 cells and MAIT cells), B-cell and antibody responses, and trained innate immunity in natural and vaccine-induced protective responses

A2. Novel approaches to vaccine discovery

• New vaccine concepts that generate non-conventional cellular immunity, protective antibody responses and trained innate immunity
• Studies to understand the determinants of protective immune responses in the lung and mucosa
• Antigen discovery, validation, and optimization 

A3. Improved formulations and delivery platforms 

• New routes of administration
• New adjuvants and immune modulators
• Experimental medicine to study outcomes of adjuvants and platforms
• Studies to evaluate the capacity of different formulation and delivery platforms to induce immune responses

B1. Model systems supporting vaccine development 

• Studies and new developments in in vitro, in vivo, and in silico models
• Progress in the development of non-animal based new approach methodologies (NAMs)  for TB vaccines (e.g. organoids, multiple organ models)
• Research to optimize animal models (e.g. fit-for-purpose animal models, immune-compromised animal models, and head-to-head testing of candidate vaccines in standardized animal models)

Note, proof-of-concept studies of novel vaccine candidates in animal models should be submitted in B3.

B2. Controlled human infection model (CHIM)

• Progress and advances in the development of a controlled human infection model for TB vaccines
• Experimental medicine to study outcomes of Mtb challenge strains 

B3. Preclinical development of novel vaccine candidates

• Design and results of proof-of-concept studies in animals 
• Design and results of preclinical safety, toxicology, and immunogenicity studies
• Preparatory activities for Phase 1 human trials

C1. Clinical trials of novel TB vaccine candidates

• Progress in clinical development of TB vaccine candidates
• Results from clinical trials
• Experiences and lessons learned for future trials

Note: Abstracts on community engagement in clinical research should be submitted in Track E3.

C2. Key  populations in clinical trials

• Approaches, considerations, and ethics for including key and vulnerable populations in clinical trials (e.g., pregnant and lactating persons, persons deprived of liberty, people living with HIV/AIDS)

C3. Assessing, building, and sustaining trial site capacity

• Epidemiology studies to identify suitable sites for clinical trials
• Addressing gaps and building site capacity for clinical trials
• Approaches to trial site sustainability

C4. Novel clinical trial design and product development

• Approaches and concepts to streamline clinical trials through novel trial designs
• TB vaccine efficacy endpoints
• Evaluating efficacy in IGRA-negative persons
• Modeling the impact of novel trial designs
• Data and information required for licensure
• Planning for post-licensure studies

D1. Potential impact and demand for new TB vaccines

• Modeling the public health and economic impact of new TB vaccines and vaccine introduction strategies
• Demand assessments for new TB vaccines

D2. Country and regional preparedness for new TB vaccines 

• Delivery systems
• National and regional regulatory, licensure and policy pathways
• Country-led implementation planning
• Domestic financing for procurement and rollout of new TB vaccines

D3. Global financing, policy, and procurement for the introduction of new TB vaccines

• Global procurement strategies and mechanisms
• Global financing mechanisms for procurement and rollout of new TB vaccines
• Global regulatory policies and considerations (e.g. prequalification, target product profiles, policy bodies)

D4. Manufacturing and technology transfer

• Strengthening manufacturing capacity in high burden countries
• Technology transfer

E1. Funding TB vaccine research and development

• Strategies and approaches to broaden the funding base of for TB vaccines, including from high-burden countries, and promote sustainable and flexible funding strategies
• Innovative financing mechanisms, including “push” and “pull” mechanisms; applying experiences from other vaccines to TB.
• Incentives for increased investment in early-stage research and early vaccine production and manufacturing.

Note: Abstracts on financing implementation and roll-out of new TB vaccines should be submitted under D2 (country/regional level) or D3 (global level)

E2. Advocacy and policy

• Approaches to building political will and commitments to new TB vaccines
• Advocacy to promote accountability for meeting existing targets and commitments and to prioritize TB vaccine R&D in the global health agenda
• Engaging ministers, parliamentarians, ministers, and other policymakers in TB vaccine R&D
• Engaging researchers in advocacy efforts

E3. Engaging communities from end-to-end

• Promoting TB vaccine research literacy
• Supporting community participation in national, regional, and global conferences, forums, and other discussion and decision-making platforms
• Effective strategies and experiences in engaging communities in all stages of the research process
• Social science research to assess community values and perceptions and address potential barriers to participation in TB vaccine clinical trials and uptake of new TB vaccines once licensed
• Communications strategies to ensure effective dissemination of accurate information and address vaccine hesitancy and misinformation

E4. Stakeholder engagement and collaboration

• New approaches to research partnerships and collaborations to advance TB vaccine concepts and candidates
• Promoting multisectoral collaboration, coordination, and alignment across stakeholder groups