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Safety and Immunogenicity of H3N2 M2SR monovalent influenza vaccine in older subjects

Award Number: U01AI141310
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/25/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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Safety and Immunogenicity of H3N2 M2SR monovalent influenza vaccine in older subjects - Respiratory infections with influenza viruses cause severe morbidity and mortality in humans and animals worldwide. Importantly, in humans, the majority of morbidity and mortality following flu infection is seen in older individuals (> 65 years old). Yet, clear understanding of how aging impacts on immune responses, and how to improve vaccine design in this age group is lacking. Restimulating preexisting memory T cells against conserved epitopes in influenza virus by a vaccine might confer protective immunity in this age group. An ideal vaccine for elderly should therefore engage pattern recognition receptors (PRRs) that activate antigen-presenting cells (APCs), generate conserved antigenic epitopes, while avoiding overt inflammatory responses. We have demonstrated that ex-vivo stimulation with M2SR virus results in robust restimulation of memory CD4 and CD8 T cells in older humans without causing pathological inflammation by engaging non-inflammasome dependent innate pathways. We have shown in a Phase 1a clinical study that M2SR is generally safe and well-tolerated with the ability to elicit immune responses in seronegative, seropositive and seroprotected subjects. Subsequently, we showed that M2SR recipients provided protection against a highly drifted influenza virus. In this proposal, we will explore the ability of M2SR to stimulate antiviral immune responses in older subjects in the following aims: Aim 1. Conduct Phase 1b study testing safety and immunogenicity of M2SR in older subjects. Aim 2. Evaluate immune responses from older human subjects vaccinated with M2SR These experiments are aimed at improving protection of older humans from influenza-mediated disease, by understanding the immune responses that contribute to protective immunity. The outcome of the experiments is expected to have high impact with respect to the fundamental understanding of the ability of M2SR to elicit immune responses in the susceptible elderly population, and in demonstrating safety of an effective vaccine dosing regimen.


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: 2024 ( Subtotal = $0 )
2024	2022	FLUGEN INC	597 SCIENCE DR	MADISON	WI	53711	DANE	USA	Allergy and Infectious Diseases Research	000	3	3/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,304,188 )
2022	2022	FLUGEN, INC.	597 SCIENCE DR STE 10	MADISON	WI	53711	DANE	USA	Allergy and Infectious Diseases Research	000	3	6/28/2022	NON-COMPETING CONTINUATION	$1,304,188
														Subtotal = $1,304,188

Issue Date FY: 2021 ( Subtotal = $1,301,311 )
2021	2021	FLUGEN, INC.	597 SCIENCE DR STE 10	MADISON	WI	53711	DANE	USA	Allergy and Infectious Diseases Research	000	2	6/23/2021	NON-COMPETING CONTINUATION	$1,301,311
														Subtotal = $1,301,311

Issue Date FY: 2020 ( Subtotal = $1,311,111 )
2020	2020	FLUGEN, INC.	597 SCIENCE DR STE 10	MADISON	WI	53711	DANE	USA	Allergy and Infectious Diseases Research	000	1	8/25/2020	NEW	$1,311,111
														Subtotal = $1,311,111

Grand Total All Awards = $3,916,610

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Safety and Immunogenicity of H3N2 M2SR monovalent influenza vaccine in older subjects

Award Number: U01AI141310

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/25/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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