Table 1.
Priority Activities as Expressed in the Vaccine Development Technology Roadmap for Group A Streptococcus Vaccines
| Key Strategic Areas | Proposed Priority Activities |
| Research | Improve global estimates of disease burden and better characterize the epidemiology of GAS infections |
| Further describe the spectrum of natural disease history | |
| Drive improved understanding of GAS-related secondary immune-mediated diseases | |
| Define the consequences of GAS-associated antibiotic use, and estimate the impact of vaccine use on antibiotic use and antimicrobial resistance–related morbidity and mortality | |
| Vaccine development | Pursue antigen discovery efforts, increasing the number of pipeline vaccine candidates |
| Develop consensus guidance about the appropriate use of safety monitoring tools in candidate vaccine trials | |
| Characterize immunological surrogates/correlates of protection | |
| Define appropriate pivotal clinical trial design adapted to near-term and long-term strategic goals | |
| Key capacities | Define appropriate use of available and future animal models for GAS vaccine safety and efficacy evaluation according to their relevance for human responses |
| Develop clinically relevant human GAS experimental infection model(s) to support early vaccine proof-of-concept evaluation | |
| Establish GAS expert research centers in LMICs with Good Clinical Practices trial research capacity and appropriate regulatory and ethical oversight; establish baseline rates of efficacy and safety outcomes | |
| Access low-cost vaccine manufacturing under current Good Manufacturing Practices for late-stage development and commercial production | |
| Develop standardized immunoassay platforms that meet quality requirements | |
| Policy, commercialization, and delivery | Establish cost-effectiveness and develop research and implementation financial investment scenario(s) to support appropriate funding and policy decision making at the global and national levels, considering the full scope of costs and benefits |
| Ensure availability, affordability, and acceptability of a functional, cost-effective delivery platform for immunization | |
| Develop effectiveness and safety vigilance platforms for postimplementation surveillance |
Abbreviations: GAS, group A Streptococcus; LMICs, low- and middle-income countries.