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A next-generation meningococcal serogroup B vaccine with improved effectiveness for all age groups

Award Number: R44AI124759
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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A next-generation meningococcal serogroup B vaccine with improved effectiveness for all age groups - Abstract Neisseria meningitidis is a major cause of meningitis and septicemia. Serogroup B (MenB) strains account for most cases of invasive disease in infants and teenagers and nearly all U.S. college outbreaks. The MenB capsule cross-reacts with host antigens, which precluded development of a capsular-based MenB conjugate vaccine. Two manufacturers developed MenB vaccines that target protein antigens. Both contain recombinant meningococcal Factor H binding protein (FHbp) and are licensed in the U.S. for teenagers and young adults but not for infants and young children, the age groups at greatest risk. OMVax, Inc. is developing an improved MenB vaccine for all age groups, including infants and young children. We have shown that binding of host complement Factor H (FH) to FHbp vaccines decreases protective antibody responses and that immunization of healthy young adults with a licensed MenB vaccine can elicit autoantibodies to FH, which may pose safety issues. The OMVax vaccine uses proprietary native outer membrane vesicle (NOMV) technology with genetically attenuated endotoxin that preserves native structures, combined with over-expressed mutant FHbp antigens with low binding to FH. In infant macaques, a prototype NOMV-FHbp vaccine elicited greater protection as reflected by broader and higher serum bactericidal activity (SBA) titers than a licensed MenB vaccine and, unlike the licensed vaccine, did not elicit anti-FH autoantibodies. The OMVax vaccine also protects against non-B strains causing epidemics in Africa. Our hypotheses are that the OMVax vaccine is more effective and better tolerated than currently licensed MenB vaccines and that it will decrease nasopharyngeal colonization and thereby provide community protection, a key limitation of current MenB vaccines. In Aim 1 we will develop production strains (one each with over-expressed FHbp from sub-family A or B) for GMP-compliant process and formulation and development of analytical methods suitable for release of Phase 1 vaccine product. We will characterize research vaccine lots for immunogenicity studies in mice, toxicology in rabbits and stability testing in vitro and with mouse potency assays. The data will allow preparation of SOPs and batch record production to produce a lot of vaccine suitable for Phase 1 human testing. In Aim 2, we will establish human complement SBA methods for demonstrating vaccine efficacy. Strain susceptibility to anti-FHbp SBA can be affected by variations in both FHbp amino acid sequence and level of expression, and we will develop assays using 4 to 8 epidemiologically relevant MenB strains with different FHbp sequence variants and expression levels. The assays will be used to assess immunogenicity of NOMV-FHbp research lots in mice and, subsequently, for GLP-compliant testing of Phase 1 human sera. The proposed studies will help predict coverage of relevant MenB strains and enable NOMV-FHbp to undergo safety and immunogenicity testing in healthy adults and, subsequently, in adolescents and younger age groups, including infants, necessary for licensure of what OMVax anticipates to be a more effective and safer MenB vaccine for all age groups.


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	OMVAX, INC.	1700 MONTGOMERY ST STE 108	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	4	6/4/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	4	5/13/2022	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	5/6/2021	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $1,000,000 )
2020	2020	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	2	6/11/2020	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $3,000,000

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A next-generation meningococcal serogroup B vaccine with improved effectiveness for all age groups

Award Number: R44AI124759

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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