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Feasibility Evaluation of an Oral Typhoid Fever Vaccine

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
65983
Program Year/Program:
2003 / SBIR
Agency Tracking Number:
AI053910
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
AVANT IMMUNOTHERAPEUTICS, INC.
AVANT IMMUNOTHERAPEUTICS, INC. 119 4TH AVE NEEDHAM, MA 02494 0272
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2003
Title: Feasibility Evaluation of an Oral Typhoid Fever Vaccine
Agency: HHS
Contract: 1R43AI053910-01
Award Amount: $126,861.00
 

Abstract:

DESCRIPTION (provided by applicant): Ty800 is a live attenuated Salmonella typhi organism intended to be used as a prophylactic single dose oral vaccine for Typhoid fever. Ty800 may have advantages in several respects to current Typhoid fever vaccines, and consequently could be a significant advance when it reaches the market. Ty800 has been given to a limited number of human subjects and immunogenicity has been demonstrated. The goal of this Phase I SBIR grant is to conduct an initial series of experiments to, in part, demonstrate that Ty800 has the necessary basic elements to be a viable marketed human vaccine. Consequently, the specific aims of this proposal during the requested funding period are to 1) determine a protocol for the in vivo Ty800 General Safety Test, suitable to meet the regulations for product release, and to perform an initial GLP General Safety Test using this protocol; 2) perform preliminary evaluations of a Ty800 immunogenicity animal model, with the goal of helping define an animal model for future toxicology studies; 3) develop immunochemistry assays to evaluate the immunogenicity of Ty800 in preclinical animal models and to help define the assays to be used in future clinical trials; 4) evaluate the environmental release survivability of Ty2 and Ty800; 5) determine the antibiotic sensitivity profile of Ty800 using the Kirby-Bauer Method; 6) demonstrate the precise genetic deletion at the phoP/phoQ regulon by sequencing the Ty800 chromosomal DNA.

Principal Investigator:

Lawrence J. Thomas
7814333163
LTHOMAS@AVANTIMMUNE.COM

Business Contact:

Una Ryan
7814330771
URYAN@AVANTIMMUNE.COM
Small Business Information at Submission:

AVANT IMMUNOTHERAPEUTICS, INC.
AVANT IMMUNOTHERAPEUTICS, INC. 119 4TH AVE NEEDHAM, MA 02494

EIN/Tax ID: 133191702
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No