A Mucosal Vaccine for HSV-2

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,563,533.00
Award Year:
2009
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI063820-03
Award Id:
80604
Agency Tracking Number:
AI063820
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
BIOMEDICAL RESEARCH MODELS, INC., 67 MILLBROOK, ST, STE 422, WORCESTER, MA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
015341134
Principal Investigator:
KEJIANYANG
(508) 459-7544
KYANG@BIOMERE.COM
Business Contact:
DENNISGUBERSKI
() -
dguberski@biomere.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Approximately 1 out of every 5 Americans is infected with herpes simplex virus type 2 (HSV-2). Localized genital infection by HSV-2 results in painful recurring genital lesions while disseminated infection can involve m ultiple visceral organs and lethal encephalitis. Using Phase 1 funding we have developed a new heterologous immunization protocol composed of a glycoprotein D (gD) DNA vaccine followed by a liposome-encapsulated gD boost. This protocol induces robust serum IgG antigen-specific antibodies, mucosal IgG and secretory IgA and a T helper type 1 (Th1)-biased immune response. Mice immunized with this protocol are protected from disease after infection with 100 times the lethal dose of virus. Use of a higher primin g dose of DNA revealed sterilizing immunity in 80% of immunized mice. We are requesting Phase 2 funding to complement and extend the studies in preparation for preclinical safety testing. The requested funding will be used to further characterize immune me diators induced by the novel HSV-2 vaccine. Funding will also be used to evaluate commercial suppliers of vaccine components and establish quality control parameters. Dosing of components will be further optimized in preparation for human use and toxicity testing. Guinea pigs will be used to demonstrate efficacy of the vaccine in a second animal model and to test the ability of the vaccine to prevent establishment of latency and/or reactivation of latent virus. The end result of these experiments will be th e establishment of a novel vaccine for HSV-2. PUBLIC HEALTH RELEVANCE: This vaccine would clearly have an impact on the greater than 1.6 billion spent annually on direct medical costs associated with HSV-2. The Public Health Service (PHS) has recognized t he significant public health issues caused by herpes simplex virus. The PHS publication, Healthy People 2010 , has set sexually transmitted diseases as a national priority with a goal to reduce the number of adults infected with human papilloma virus and HSV-2.

* information listed above is at the time of submission.

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