Lyme disease is a significant public health treat, it is the most prevalent vector borne infectious disease in the United States, and its geographical range is expanding. The white-footed mouse is the major natural reservoir of Borrelia burgdorferi, the etiological agent of Lyme disease. Ixodes scapularis ticks acquire B. burgdorferi from infected mice (and other wildlife reservoirs) and transmit it to uninfected mice. This cycle maintains the zoonosis in endemic areas. Breaking the mouse-tick cycle by eliminating B. burgdorferi from its mouse reservoir and/or from the ticks that feed on them would markedly reduce the risk of Lyme disease. The goal of this proposal is to develop an oral immunization delivery system that can be safely deployed into the wild in endemic areas to vaccinate vertebrates known to be reservoir hosts for B. burgdorferi therefore breaking the enzootic cycle of this pathogen. In Phase I of this SBIR we proposed to develop an oral wildlife bait vaccine comprised of OspA, and if effective, OspC/OspA, using E. coli as a freeze-dried vehicle for immunogen delivery. In this Phase II proposal, the vaccine formulation developed in Phase I will be delivered orally to Lyme disease susceptible inbred mice. First, mice will be immunized by oral gavage inoculation and subsequently challenged by B. burgdorferi infected I.scapularis (nymphs). Second, a bait vaccine will be tested by admixing mouse chow with freeze-dried E. coli expressing the immunogen and challenging the mice as described above. Additionally, we will begin performance testing required for regulatory review. The development of an inexpensive, highly specific, effective, and easily distributable vaccine to decrease the prevalence of B. burgdorferi in tick populations around human communities could significantly reduce the incidence of Lyme disease cases within the several years of its introduction and will lead to the indirect control of human Lyme disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
4R44AI058364-02
Application #
7028772
Study Section
Special Emphasis Panel (ZRG1-SSS-4 (14))
Program Officer
Baker, Phillip J
Project Start
2004-08-01
Project End
2007-02-28
Budget Start
2005-03-15
Budget End
2006-02-28
Support Year
2
Fiscal Year
2005
Total Cost
$437,219
Indirect Cost
Name
Biopeptides, Inc.
Department
Type
DUNS #
140704532
City
East Setauket
State
NY
Country
United States
Zip Code
11733
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Richer, Luciana Meirelles; Brisson, Dustin; Melo, Rita et al. (2014) Reservoir targeted vaccine against Borrelia burgdorferi: a new strategy to prevent Lyme disease transmission. J Infect Dis 209:1972-80
Meirelles Richer, Luciana; Aroso, Miguel; Contente-Cuomo, Tania et al. (2011) Reservoir targeted vaccine for lyme borreliosis induces a yearlong, neutralizing antibody response to OspA in white-footed mice. Clin Vaccine Immunol 18:1809-16
del Rio, Beatriz; Dattwyler, Raymond J; Aroso, Miguel et al. (2008) Oral immunization with recombinant lactobacillus plantarum induces a protective immune response in mice with Lyme disease. Clin Vaccine Immunol 15:1429-35
Gomes-Solecki, Maria J C; Meirelles, Luciana; Glass, John et al. (2007) Epitope length, genospecies dependency, and serum panel effect in the IR6 enzyme-linked immunosorbent assay for detection of antibodies to Borrelia burgdorferi. Clin Vaccine Immunol 14:875-9
Gomes-Solecki, Maria J C; Brisson, Dustin R; Dattwyler, Raymond J (2006) Oral vaccine that breaks the transmission cycle of the Lyme disease spirochete can be delivered via bait. Vaccine 24:4440-9