# Universal Influenza A/B Vaccine

> **NIH NIH R44** · ORLANCE, INC. · 2022 · $1,000,000

## Abstract

Abstract
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

## Key facts

- **NIH application ID:** 10539015
- **Project number:** 4R44AI153011-02
- **Recipient organization:** ORLANCE, INC.
- **Principal Investigator:** Kenneth C Bagley
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 4N
- **Project period:** 2020-08-07 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10539015

## Citation

> US National Institutes of Health, RePORTER application 10539015, Universal Influenza A/B Vaccine (4R44AI153011-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10539015. Licensed CC0.

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