Batzloff, Michael R., Fane, Anne, Gorton, Davina, Pandey, Manisha, Rivera-Hernandez, Tania, Calcutt, Ainslie, Yeung, Grace, Hartas, Jon, Johnson, Linda, Rush, Catherine M., McCarthy, James, Ketheesan, Natkunam, and Good, Michael F. (2016) Preclinical immunogenicity and safety of a Group A streptococcal M protein-based vaccine candidate. Human Vaccines & Immunotherapeutics, 12 (12). pp. 3089-3096.

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Abstract

Streptococcus pyogenes (group A streptococcus, GAS) causes a wide range of clinical manifestations ranging from mild self-limiting pyoderma to invasive diseases such as sepsis. Also of concern are the post-infectious immune-mediated diseases including rheumatic heart disease. The development of a vaccine against GAS would have a large health impact on populations at risk of these diseases. However, there is a lack of suitable models for the safety evaluation of vaccines with respect to post-infectious complications. We have utilized the Lewis Rat model for cardiac valvulitis to evaluate the safety of the J8-DT vaccine formulation in parallel with a rabbit toxicology study. These studies demonstrated that the vaccine did not induce abnormal pathology. We also show that in mice the vaccine is highly immunogenic but that 3 doses are required to induce protection from a GAS skin challenge even though 2 doses are sufficient to induce a high antibody titer.

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