A novel live intranasal TB vaccine

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41AI100457-01
Agency Tracking Number: R41AI100457
Amount: $600,000.00
Phase: Phase I
Program: STTR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIAID
Solicitation Number: PA10-124
Small Business Information
PATHENS, INC.
220 Riverbend Road, Athens, GA, -
DUNS: 602672813
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 FREDERICK QUINN
 (706) 542-5790
 fquinn@uga.edu
Business Contact
 RUSSELL KARLS
Phone: (706) 340-0180
Email: rkarls@pathens.com
Research Institution
 UNIVERSITY OF GEORGIA (UGA)
 200 D.W. Brooks Drive
Office for Sponsored Programs 617 Boyd, GSRC
ATHENS, GA, 30602-5016
 () -
 Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): The most-widely used vaccine for TB currently is BCG, a live avirulent variant of M. bovis that is given intradermally at birth. Along with the inherent safety and logistical problems associated with being injected, protective efficacy is generally poor and wanes by adolescence. BCG administration to an immunosuppressed individual also can disseminate and lead to serious life- threatening infection. Second-generation BCG vaccines, modified to express Mycobacterium tuberculosis (Mtb) antigens, such as Ag85B, are in human clinical trials. Unfortunately, these vaccines also are injected and retain the inherent safety risk to the immunosuppressed population. TBVac85 is a novel, live, attenuated intranasal TB vaccine. It is acold-adapted, temperature-restricted derivative of Mycobacterium shottsii engineered to express Ag85B. TBVac85 is naturally adjuvantic due to cell wall and antigenic similarities to Mtb. Intranasal TBVac85 possesses the potential benefits associated with recombinant BCG vaccines, with enhanced safety for the immunocompromised afforded by temperature-restricted growth and intranasal (needle-free) immunization. Our preliminary studies demonstrated a lack of toxicity or pathogenicity in the nasal passages andlungs of mice and guinea pigs intranasally vaccinated and boosted with TBVac85 over subsequent weeks. We also have demonstrated lack of persistence by TBVac85 bacteria, both locally and in the lungs and spleens of the immunized animals. Finally, we demonstrated humoral and cellular responsiveness in TBVac85-immunized guinea pigs through the detection of serum antibodies and positive skin test responses to Ag85B and tuberculin. The next stage of development of TBVac85 and the subject of this proposal is to determine the protective efficacy of intranasal TBVac85 against Mtb challenge in the guinea pig aerosol infection model. If more protective than BCG, TBVac85 will be examined for protective efficacy in a non-human primate model in the phase II application.PUBLIC HEALTH RELEVANCE: The goal of the proposed research is to determine the protective efficacy of intranasal TBVac85 against Mtb challenge in the guinea pig aerosol infection model. If more protective than BCG, TBVac85 will be examined for protective efficacy in a non-human primate model in the phase II application.

* information listed above is at the time of submission.

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