Preclinical immunogenicity and safety of a Group A streptococcal M protein-based vaccine candidate

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.

Item ID: 45263
Item Type: Article (Research - C1)
ISSN: 2164-554X
Funders: National Heart Foundation of Australia (NHF), National Health and Medical Research Council (NHMRC), National Institute of Health (NIH), USA, Cooperative Research Centre for Aboriginal Health (CRCAH)
Projects and Grants: NIH U01-AI060579-01
Date Deposited: 23 Aug 2016 22:40
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1107 Immunology > 110799 Immunology not elsewhere classified @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920108 Immune System and Allergy @ 50%
92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920109 Infectious Diseases @ 50%
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