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Development of a Marburgvirus subunit vaccineadjuvanted with a novel TLR7/TLR8 agonist

Award Number: R43AI181292
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: 02/26/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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Development of a Marburgvirus subunit vaccineadjuvanted with a novel TLR7/TLR8 agonist - There is an outbreak of Marburg virus disease (MVD), relative of Ebola virus, currently ongoing in Equatorial Guinea and Tanzania. There have been multiple, deadly outbreaks of MVD in the past with ~88% lethality. There are currently no approved vaccines or therapeutics for MVD and very few in clinical development. In this proposal, we have rationally designed an immunogen based on MARV glycoprotein (GP) by excluding domains known to trigger non-neutralizing antibodies allowing exposure of key neutralizing epitopes capable of generating a strong immune response. Combined with a novel TLR7/8 agonist adjuvant, Alhydroxyquim- II (AhQ-II), that has shown excellent safety and adjuvant activity in millions of people during COVID-19 pandemic, our rationally designed MARV vaccine induces broadly neutralizing antibodies against isolates Angola, CI67, and Musoke strains of MARV as well as the phylogenetically more distant RAVV. Mice immunized with this MARV vaccine with two or three doses compared to unadjuvanted antigen showed robust antigen-specific binding and neutralizing titers against all four MARV strains demonstrated by ELISA and pseudovirus neutralization assays. In the guinea pig model of MARV infection which shows all hallmarks of filovirus disease the vaccine provided 100% protection against lethal challenge with no detectable viremia, suggesting that the vaccine is likely inducing sterilizing immunity. In summary, this subunit vaccine represents a novel, highly efficacious, and safe candidate for protection against MVD. Here, we propose three specific aims to further develop this rationally designed immunogen: Aim1: To produce and generate a pooled stable cell line for the MARV subunit antigen with a cGMP-compliant tag and demonstrate biochemical and immunogenic properties comparable to the Streptavidin-tagged MARV material used in preliminary studies; Aim 2: to determine optimal effective dose and regimen for maximum protection in BSL-4 guinea pig MARV model; Aim 3: to demonstrate immunogenicity in the filovirus Gold Standard non-human primate model. Upon successful completion of this Phase I project we anticipate a Phase II focused on NHP efficacy studies and advanced development activities.


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: 2026 ( Subtotal = $0 )
2026	2025	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	11/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $297,099 )
2025	2025	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	1/17/2025	NON-COMPETING CONTINUATION	$297,099
														Subtotal = $297,099

Issue Date FY: 2024 ( Subtotal = $299,528 )
2024	2024	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	2/26/2024	NEW	$299,528
														Subtotal = $299,528

Grand Total All Awards = $596,627

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Development of a Marburgvirus subunit vaccineadjuvanted with a novel TLR7/TLR8 agonist

Award Number: R43AI181292

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: 02/26/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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