DNA Prime / Subunit Boost Multi-Antigen Universal Influenza Vaccine

Period of Performance: 06/15/2016 - 05/31/2017


Phase 1 SBIR

Recipient Firm

Profectus Biosciences, Inc.
Baltimore, MD 21224
Principal Investigator


ABSTRACTA universal influenza vaccine is believed to be possible if conserved regions of influenza are effectively targetedand appropriate immune responses are generated against those targets. The enhanced safety, stability, andaccelerated product development generally provided by DNA vaccination make it an appealing approach todevelop such a universal influenza vaccine. Unfortunately, immune responses to universal influenza antigensare typically weak and in the past, DNA vaccination of humans has been disappointing. To overcome these andother obstacles to developing an effective, practical, and truly universal influenza vaccine, we intend to deliverour vaccine using a DNA prime / protein boost regimen and employ novel immunogens derived from the followingthree conserved influenza A antigens: 1) the stem region of hemagglutinin (HA); 2) the matrix 2 proteinectodomain (M2e); and, 3) the nucleoprotein (NP). We believe that together, these antigens will evoke theimmunological breadth necessary to protect against a broad range of both seasonal and potential pandemicinfluenza strains. We will also use a potent DNA adjuvant combination to maximize immunogenicity and to tunethe responses toward a Th1 phenotype. Finally, we will utilize a recombinant protein boost to amplify the humoralimmune responses and increase their durability. In this Phase I SBIR, we will construct and express our influenzaA immunogens and verify their immunogenicity and protective efficacy in mice to determine if the vaccineprovides a wide breadth of protection from divergent seasonal and pandemic influenza A strains. If we aresuccessful in this Phase I proof-of-concept study, we will move on to test our vaccine in a macaque challengemodel under a Phase II application and begin development on influenza B, and possibly type C, immunogens.