Shigella conjugate vaccine (SCV4) development, characterization, and pre-clinical evaluation
Active Project Grant Awarded Last action
- Award ID
- R01AI177075
- Recipient
-
The General Hospital Corporation UEI FLJ7DQKLL226
- Awarding agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $5,262,530
Award facts
- Assistance listing
- 93.855 Allergy and Infectious Diseases Research
- Completion date 67% complete
- Place of performance
- Boston, MA 02114, USA
Award details come from USAspending.gov.
Description
- Abstract
- Shigella infection is a leading cause of diarrheal illness in young children in resource-limited settings, and results in tens of thousands of deaths each year. Protection against shigellosis is largely associated with antibodies targeting o-specific polysaccharide (OSP) of lipopolysaccharide (LPS) of shigella SPP. A vaccine protective against shigella will need to be effective in young children in resource-limited areas of the world. Young children do not develop high level or durable immune responses against polysaccharides such as OSP unless they are presented in a t cell dependent manner. In comparison, young children mount high level and durable immune responses when polysaccharides are conjugated to carrier protein. Here, we propose an international partnership to advance a quadrivalent shigella conjugate vaccine (SCV4) targeting shigella flexneri 2A, 3A, 6 and s. Sonnei. SCV4 will be comprised of osps recovered from identified source strains and will be linked to carrier protein rtthc using squaric acid chemistry. Our partnership has advanced a cholera conjugate vaccine using this approach that has undergone product development, stability testing, toxicologic assessment and preclinical evaluation, and is initiating phase 1 evaluation in humans in Q4 '22. We thus propose to adapt our already established scalable and manufacturable protocols, building upon our preliminary data showing that shigella conjugate vaccines using our platform approach are immunogenic and protective in animal models. We will produce SCV4 (monovalent and CO-formulated), characterize product, and assess immunogenicity and protective efficacy in mice, guinea pigs and a non-human primate model. Our goal is the development of reproducible, scalable, manufacturing protocols for production of scvs and SCV4 to support technology transfer to a future manufacturing partner. Proposed product development will be through a partnership that includes the vaccine process development team at the international vaccine institute (IVI), south korea that has expertise in vaccine product development and a history of successful technology transfer to vaccine manufacturers in resource-limited areas. The ultimate goal is development of a SCV that can be incorporated into the expanded programme on immunizations (EPI) for use in 12- 24 month old children in lmic settings with high shigella burden.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $1,117,414 | |
| Amendment | $1,143,199 | |
| Amendment | $981,139 | |
| Amendment | $1,010,389 | |
| Original award | $1,010,389 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| The Administrators Of Tulane Educational Fund | $863,589 | |
| International Vaccine Institute | $888,938 | |
| University Of Toledo | $217,292 |
Quick answers
Who received award R01AI177075?
R01AI177075 was awarded to The General Hospital Corporation by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on June 23, 2023.
How much is award R01AI177075 worth?
$5,262,530 has been obligated on R01AI177075.
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