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Intranasal Vaccine Against Lyme Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI167605-01A1
Agency Tracking Number: R44AI167605
Amount: $1,988,528.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-07-12
Award End Date (Contract End Date): 2025-06-30
Small Business Information
3 N. Dunlap Street
Memphis, TN 38163
United States
DUNS: 078468131
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (901) 448-2536
Business Contact
Phone: (901) 448-2536
Research Institution

We propose to develop intranasal, parainfluenza 5 (PIV5) viral-vector delivered vaccines
against human Lyme disease (LD) to be administered using a prime-boost schedule, for the US
market. A recent new estimate of LD by the CDC places the new number at 476,000 annual
cases, up from 329,000 in 2015 which strongly suggests that the number of Americans affected
by this vector-borne disease is increasing. Currently, there is no human Lyme Disease vaccine
available in the market. A prime-boost vaccination with an intranasal immunogen is a scientific
and technologic advance over best vaccination protocols in development for LD that currently
rely on parenteral inoculation of a minimum of 3 doses over 1 year. Our preliminary studies
show that intranasal administration of a modified OspA vaccine delivered by the laboratory
strain WR-PIV5 viral vector (WR-PIV5-OspABPBPk) via prime-boost (2 doses), produces an
immune response that is 100% protective against tick transmitted B. burgdorferi infection in
mice challenged 4 months after the 1st dose. PIV5 is a safe delivery vector used to develop
many vaccines, one of which is undergoing a human clinical trial. The commercialization
potential and societal impact of developing a novel, safe and efficacious LD vaccine that can be
delivered by a non-invasive method is highly significant given that it may induce more durable
immune responses, it could diminish vaccine hesitancy and increase vaccine compliance, and it
could enable self-administration of one or both doses. The novelty of the vaccine proposed in
this Direct to Phase II SBIR application relates to: 1) the use of a modified full length OspA
protein in which the putative autoantigenic epitope has been replaced; 2) a needle-free
intranasal delivery method in a safe, highly immunogenic viral vector; 3) the reduced number of
immunizations; 4) ease of administration; and 5) the potential to increase immunity longevity.
We propose to develop a new viral vector expressing OspABPBPk based on the PIV5 vaccine
strain (CPI) and evaluate intranasal vaccine efficacy in mice as compared to the WR-PIV5-
ABPBPk shown in preliminary results; we will also assess immunogenicity, safety and efficacy of
the best vaccine candidate in the non-human primate (NHP) model of Lyme disease; last, we
will perform studies required for Investigational New Drug (IND) regulatory approval by FDA.
Once the novel vaccine is shown to meet pre-set performance criteria specified in our
milestones (rt80% efficacy in mice and non-human primate models), it will be trademarked as
LymeMist™ and the company will implement a plan to commercialize it.

* Information listed above is at the time of submission. *

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