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Development of a Non-adjuvanted VLP Vaccine against Stealth H7N9 Influenza

Award Number: R43AI118189
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2016
PERIOD OF PERFORMANCE END DATE: 06/30/2020

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Development of a Non-adjuvanted VLP Vaccine against Stealth H7N9 Influenza - ¿ DESCRIPTION (provided by applicant): The avian-origin H7N9 influenza virus that emerged in humans in China in 2013 presents a unique challenge to vaccine development because it is poorly immunogenic. Neutralizing antibodies are not detected in acute-phase infection. Anti-H7 antibody responses are significantly delayed and exhibit low avidity, in comparison with antibodies generated following seasonal influenza vaccination and infection. Furthermore, unadjuvanted H7N9 vaccines developed using conventional approaches elicit weak hemagglutinin-inhibition (HAI) antibody titers in clinical trials. Adjuvanted formulations may overcome this limitation but present significant regulatory challenges because adverse effects have recently been associated with adjuvanted influenza vaccines. Alternative vaccine approaches are needed to redress the low immunogenicity of H7N9 and circumvent safety risks. Because HAI titers are directly related to effector CD4+ T cell frequencies induced by vaccination, we hypothesize that a vaccine strategy that enhances effector CD4+ T cell activation will improve H7N9 vaccine efficacy without requiring adjuvant formulation. In published studies, we observed that the T cell epitope content of H7N9 virus differs significantly from more immunogenic influenza subtypes. H7N9 contains fewer T cell epitopes and some epitopes stimulate regulatory T cells (Tregs) that may help the virus evade effector responses needed for protection. These findings suggest that H7N9 vaccine design that carefully addresses the T cell subsets primed by immunization will overcome limitations of conventional vaccine approaches. The goal of this research program is to produce an unadjuvanted, influenza H7N9 virus-like particle (VLP) vaccine that augments effector CD4+ T cell responses and diminishes Treg effects for enhanced protection against disease. This new SBIR program will apply cutting edge computational and experimental methods that EpiVax has successfully applied against influenza and other viral and bacterial pathogens, as well as deep experience in influenza VLP production and vaccine testing in collaboration with Dr. Ted Ross at the University of Georgia. Two different engineered VLP strategies will be tested: (i) addition of effector epitopes and (ii) removal of Treg epitopes. Using these prototype effector T cell epitope-enhanced VLP vaccines in the proof-of-concept program described here, we will evaluate the vaccines for immunogenicity and efficacy and move forward in a Phase II program to further optimize efficacy and complete safety/toxicity studies in the run up to clinical trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2017	EPIVAX, INC.	188 VALLEY ST STE 424	PROVIDENCE	RI	02909	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	2	1/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	EPIVAX, INC.	188 VALLEY ST STE 424	PROVIDENCE	RI	02909	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	2	6/6/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $290,546 )
2017	2017	EPIVAX, INC.	146 CLIFFORD ST STE 3	PROVIDENCE	RI	02903	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	2	6/21/2017	NON-COMPETING CONTINUATION	$290,546
														Subtotal = $290,546

Issue Date FY: 2016 ( Subtotal = $300,000 )
2016	2016	EPIVAX, INC	146 CLIFFORD STREET	PROVIDENCE	RI	02903	PROVIDENCE	USA	Allergy and Infectious Diseases Research	000	1	6/27/2016	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $590,546

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Development of a Non-adjuvanted VLP Vaccine against Stealth H7N9 Influenza

Award Number: R43AI118189

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2016

PERIOD OF PERFORMANCE END DATE: 06/30/2020

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