The development of vaccines can be divided into stages, from discovery to implementation. The TB Vaccine Development Pathway proposes an assessment process to track progress and make decisions on the advancement of a TB vaccine candidate to its next stage of development.
The TB Vaccine Development Pathway was established by a team of scientific and technical experts from TBVI and Aeras with the input of the TB vaccine community. The tool has been developed on behalf of the Global TB Vaccine Partnership (GTBVP), an alliance of organisations that aim at making novel TB vaccines a reality, and is funded by the Bill & Melinda Gates Foundation.
Stage A
DISCOVERY

Perform discovery, safety, immunogenicity and efficacy evaluation in initial animal model

Gate A
Progress to POC Studies

Progress to proof of concept (POC) studies in animals

Stage C
Pre-clinic evaluations

Perform Pre-Clinical evaluations

Gate C
Progress to preparation

Progress to preparation for Phase 1, First-In-Human

Stage D
Prepare FIH/Ph 1

Perform GMP and toxicity studies and prepare Clinical Trial Application

Stage E
FIH/Ph1

Perform, First-in-human/Ph1

Stage F
Ph2

Perform Ph2 (including Pre-POC) studies

Stage G
Ph 2b

Perform Ph2b Efficacy

Registration
Functions
Project Management
Business/ Legal/ Market
Product Characterization and quality
Production process
Preclinical Safety
Preclinical Immunogenicity
Preclinical Protection/efficacy
Regulatory
Clinical Development and Operations
Clinical Safety
Clinical Immunology
Clinical Efficacy
Market Access