Development of a Recombinant Vaccine Against Streptococcus Pyogenes Infection and Disease

Award Information
Agency:
Department of Defense
Branch
Army
Amount:
$100,000.00
Award Year:
2012
Program:
STTR
Phase:
Phase I
Contract:
W81XWH-12-C-0183
Award Id:
n/a
Agency Tracking Number:
A12A-027-0056
Solicitation Year:
2012
Solicitation Topic Code:
A12a-T027
Solicitation Number:
2012.A
Small Business Information
2213 Evening Sun RD, Nazareth, PA, 18064-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
962757584
Principal Investigator:
Garry Morefield
President
(610) 573-9620
garry.morefield@vaxform.com
Business Contact:
Garry Morefield
President
(610) 573-9620
garry.morefield@vaxform.com
Research Institution:
Purdue University
Harm Hogenesch
625 Harrison ST
West Lafayette, IN, 47907-
(765) 496-2026
Nonprofit college or university
Abstract
In this phase I proposal we propose development studies for a vaccine targeting diseases caused by infection with Streptococcus pyogenes. This vaccine utilizes a recombinant fusion protein comprising of SpeA, a secreted toxin, and SpeB, a surface bound and secreted cysteine protease. Combination of these two virulence factors provides protection against most strains of the bacteria. This antigen has demonstrated promise in proof of concept potency studies in which mice were protected from toxic shock as well as infection following challenge. The overall goal is to produce a lead formulation for the SpeAB vaccine, optimized for safety, potency, and stability, which can be rapidly advanced through non-clinical safety studies and into phase I clinical trials. To achieve this goal we utilize a rational, systematic approach to formulation development allowing rapid identification of a robust formulation. The biophysical characteristics of SpeAB and how environmental factors such as pH, ionic strength, and temperature impact the antigen will be determined. Interactions with aluminum adjuvant systems will also be investigated to develop a robust vaccine formulation. Successful commercialization of this vaccine will reduce morbidity and mortality rates, as well as medical care costs, associated with S.pyogenes infection in both military and civilian populations.

* information listed above is at the time of submission.

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