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Principal Investigator: Maria Gomes-Solecki
Organization: IMMUNO TECHNOLOGIES, INC.
Fiscal Year: 2024
Award: $999,881
Funding agency: National Institute of Allergy and Infectious Diseases
ABSTRACT
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 (>80% efficacy in mice and non-human primate models), it will be trademarked as
LymeMist™ and the company will implement a plan to commercialize it.
Terms: <2019-nCoV vaccine><21+ years old><7S Gamma Globulin><Adult><Adult Human><Affect><Alum Adjuvant><American><Animal Model><Animal Models and Related Studies><Antigenic Determinants><Antigens><Assay><B burgdorferi><B. burgdorferi><Binding Determinants><Bioassay><Biological Assay><Body Tissues><Borrelia burgdorferi><Borrelia burgdorferi sensu stricto><Borreliella burgdorferi><COVID-19><COVID-19 vaccine><CV-19><Clinical Trials><Coronavirus Infectious Disease 2019><Data><Development><Dose><Early-Stage Clinical Trials><Epitopes><Genetic><Human><IgG><Immune response><Immunity><Immunization><Immunization Schedule><Immunize><Immunoglobulin G><Immunological response><Infection><Intranasal Administration><Intranasal Drug Administration><Investigational Drugs><Investigational New Drugs><Ixodida><Laboratories><Lead><Length><Length of Life><Longevity><Lyme Borreliosis><Lyme Disease><Lyme Disease Spirochete><Lyme Disease Vaccines><Marketing><Methods><Mice><Mice Mammals><Modeling><Modern Man><Monkeys><Murine><Mus><Needles><New Drug Approvals><OspA><OspA protein><OspA vaccine><Parainfluenza><Pb element><Performance><Phase><Phase 1 Clinical Trials><Phase I Clinical Trials><Primates><Primates Mammals><Production><Qualifying><Research><SARS-CoV-2 vaccine><SARS-coronavirus-2 vaccine><SBIR><Safety><Schedule><Self Administered><Self Administration><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccine><Small Business Innovation Research><Small Business Innovation Research Grant><Specific qualifier value><Specified><Technology><Ticks><Tissues><Trademark><Vaccination><Vaccines><Vector-borne disease><Vector-borne infectious disease><Vector-transmitted disease><Vector-transmitted infectious disease><Vero Cells><Viral Vector><access to vaccination><access to vaccines><adulthood><aged mice><aged mouse><alum><aluminum sulfate><cell bank><commercialization><coronavirus disease 2019><coronavirus disease 2019 vaccine><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus infectious disease-19><deliver vaccines><delivery vector><delivery vehicle><developmental><elderly mice><heavy metal Pb><heavy metal lead><hesitant to vaccination><host response><immune system response><immunogen><immunogenic><immunogenicity><immunoresponse><lyme spirochete><lyme vaccine><model of animal><nCoV vaccine><nCoV-19 vaccine><nCoV19 vaccine><new vaccines><next generation vaccines><non-human primate><nonhuman primate><novel><novel vaccines><old mice><outer surface protein A><phase I protocol><pre-clinical assessment><pre-clinical study><preclinical assessment><preclinical study><prevent><preventing><response><subcutaneous><subdermal><tick mediated transmission><tick transmission><tick transmitted><timeline><vaccination access><vaccination availability><vaccination hesitancy><vaccination protocol><vaccine access><vaccine against 2019-nCov><vaccine against COVID-19><vaccine against SARS-CoV-2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine availability><vaccine candidate><vaccine candidates against SARS-CoV-2><vaccine delivery><vaccine efficacy><vaccine for novel coronavirus><vaccine hesitancy><vaccine hesitant><vaccine protocol><vaccines preventing COVID><vaccines to prevent COVID><vector induced><vector-borne illness><vectorborne disease><vectorborne illness><vectorborne infectious disease>