Cardiac monitoring safety assessment framework for early phase group a streptococcal vaccine trials

This paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.

Citation:
Marangou J, Beaton A, Fulurija A, Carapetis J, Steer AC, Zühlke L, Keech C. Cardiac monitoring safety assessment framework for early phase group a streptococcal vaccine trials. Vaccine. 2025;60.

Keywords:
Echocardiography; rheumatic fever; prevention & control; streptococcal infections; administration & dosage; adverse effects; immunology; streptococcus pyogenes

Abstract:
This paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.