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Universal Influenza A/B Vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI153011-02
Agency Tracking Number: R44AI153011
Amount: $1,998,889.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-05-03
Award End Date (Contract End Date): 2025-04-30
Small Business Information
4000 15TH AVE NE
Seattle, WA 98195-0008
United States
DUNS: 080337564
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 937-6683
Business Contact
Phone: (734) 323-9851
Research Institution

Universal influenza vaccines should be possible if conserved antigens of influenza are effectively targeted and
effective antiviral immune responses are generated against those antigens. DNA vaccination is an appealing
approach for delivering universal influenza vaccines, however, natural immune responses to conserved influenza
antigens are typically weak and most DNA vaccines tested in humans have not elicited robust humoral immunity.
To overcome the obstacles to developing universal influenza DNA vaccines, we are using novel composite
immunogens and delivering them with a next generation Gene Gun device that combines several engineering
and formulation innovations that increase immunogenicity by increasing the number of skin cells and antigen
presenting cells expressing vaccine antigen. We have already obtained encouraging results with a universal
influenza A (UFluA) DNA vaccine. Under this SBIR proposal, we intend to test a companion universal influenza
B (UFluB) DNA vaccine to create a more comprehensive universal A/B vaccine (UFluA/B) that will provide broad
protective coverage from all influenza A and B types capable of infecting humans. If we are successful at
demonstrating that a single UFluA/B DNA vaccine can induce broad responses and protection in mice in the
phase I effort, we will advance this this product to preclinical testing under the phase II portion of this application
where we will investigate immunogenicity and protective efficacy in naïve and pre-immune ferrets and safety and
efficacy in a nonhuman primate model that closely resembles humans in their dosing, immune response to DNA
vaccination and susceptibility to influenza. If successful, these data will provide Orlance with a strong preclinical
IND data package to advance this strategy to phase I human clinical trials. 2

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

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