Clinical development strategy for a candidate group A streptococcal vaccine

Area of Science:

• Infectious Diseases
• Vaccinology
• Clinical Trial Design

Background:

• Group A Streptococcus (GAS) causes diverse illnesses, including pharyngitis, rheumatic fever, and invasive infections.
• GAS pharyngitis is common in children, leading to significant antibiotic use and serving as a precursor to acute rheumatic fever and heart disease.
• Currently, no clear clinical trial pathway exists for GAS vaccine registration.

Purpose of the Study:

• To outline a clinical development strategy for a Group A Streptococcus (GAS) vaccine.
• To detail the phases required for registering a GAS vaccine, initially targeting GAS pharyngitis.
• To establish a pathway for subsequent vaccine studies for impetigo and associated sequelae.

Main Methods:

• This review proposes a phased clinical development strategy.
• The strategy prioritizes initial vaccine development for GAS pharyngitis.
• Subsequent phases will address impetigo and other GAS-associated sequelae.

Main Results:

• A phased approach allows for an early proof of principle for GAS vaccine efficacy.
• Focusing initially on pharyngitis simplifies the development pathway.
• This strategy aims to facilitate the global availability of a preventive tool for prevalent GAS diseases.

Conclusions:

• A structured clinical development strategy is crucial for GAS vaccine registration.
• Prioritizing GAS pharyngitis offers a pragmatic initial focus.
• The ultimate goal is to provide a preventive measure against the most common GAS-related diseases worldwide.