Streptococcus pyogenes which is also known as Group A Streptococcus (GAS) is a Gram positive bacterial pathogen that is responsible for numerous diseases including relatively benign pharyngitis and skin infections to serious invasive diseases including necrotizing fasciitis and the post-infectious sequelae rheumatic fever, rheumatic heart disease and glomerulonephritis. Presently, there is no strategy for primary prevention that is proven to work in less-developed countries, so a vaccine is clearly needed. Some vaccine strategies under development may not be effective in less developed countries. Our long-term goal is the development of broad-spectrum global vaccine that prevents GAS infection and its associated diseases, including rheumatic fever. Our GAS vaccine candidate is based on a peptide antigen from the conserved region of the M-protein. We have four potential vaccine constructs that use this antigen, each of which has shown good immunogenicity, safety and protection in pre-clinical studies. There are three overall objectives for the work in the current application: (1) Progression of the most advanced of our constructs to clinical trials. At the conclusion of this work, we expect to have completed: (a) An initial phase I trial in adult volunteers in Australia. (b) A larger multicentre phase I trial in adult volunteers in Australia and adult volunteers in a developing country. (c) A small phase I trial in child volunteers in a developing country. (2) Further development of the conserved region peptide as an intranasal vaccine. (3) Field studies in a developing country to establish correlates of protection that may be used in phase II and III clinical trials of the conserved region peptide, and to establish a field site for these later-phase trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI060579-04
Application #
7286011
Study Section
Special Emphasis Panel (ZAI1-MH-M (M3))
Program Officer
Rubin, Fran A
Project Start
2004-09-15
Project End
2009-08-31
Budget Start
2007-09-01
Budget End
2008-08-31
Support Year
4
Fiscal Year
2007
Total Cost
$591,311
Indirect Cost
Name
Queensland Institute of Medical Research
Department
Type
DUNS #
758815328
City
Herston
State
Country
Australia
Zip Code
4006
Sekuloski, Silvana; Batzloff, Michael R; Griffin, Paul et al. (2018) Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial. PLoS One 13:e0198658
Campbell, Patricia Therese; Frost, Hannah; Smeesters, Pierre R et al. (2018) Investigation of group A Streptococcus immune responses in an endemic setting, with a particular focus on J8. Vaccine 36:7618-7624
Batzloff, Michael R; Fane, Anne; Gorton, Davina et al. (2016) Preclinical immunogenicity and safety of a Group A streptococcal M protein-based vaccine candidate. Hum Vaccin Immunother 12:3089-3096
Good, Michael F; Pandey, Manisha; Batzloff, Michael R et al. (2015) Strategic development of the conserved region of the M protein and other candidates as vaccines to prevent infection with group A streptococci. Expert Rev Vaccines 14:1459-70
Colquhoun, S M; Kado, J H; Remenyi, B et al. (2014) Echocardiographic screening in a resource poor setting: borderline rheumatic heart disease could be a normal variant. Int J Cardiol 173:284-9
Pandey, Manisha; Wykes, Michelle N; Hartas, Jon et al. (2013) Long-term antibody memory induced by synthetic peptide vaccination is protective against Streptococcus pyogenes infection and is independent of memory T cell help. J Immunol 190:2692-701
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Steer, Andrew C; Magor, Graham; Jenney, Adam W J et al. (2009) emm and C-repeat region molecular typing of beta-hemolytic Streptococci in a tropical country: implications for vaccine development. J Clin Microbiol 47:2502-9
Steer, Andrew C; Jenney, Adam; Kado, Joseph et al. (2009) Prospective surveillance of invasive group a streptococcal disease, Fiji, 2005-2007. Emerg Infect Dis 15:216-22
Steer, Andrew C; Jenney, Adam W J; Kado, Joseph et al. (2009) Prospective surveillance of streptococcal sore throat in a tropical country. Pediatr Infect Dis J 28:477-82

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