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Meningococcal and gonococcal vaccine to prevent invasive disease and carriage

Award Number: R01AI046464
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: 07/05/2000
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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Meningococcal and gonococcal vaccine to prevent invasive disease and carriage - Project Summary/Abstract Neisseria meningitidis (Nm) cause life-threatening bacterial meningitis and sepsis and N. gonorrhoeae (Ng) cause millions of sexually transmitted infections annually. Emerging multiple antibiotic resistance by Ng and recent increases in incidence have led to its designation as an urgent threat by the CDC. There are no licensed Nm vaccines in the US for <10 year olds, the population at greatest risk of disease and no licensed Ng vaccine. We have developed an Nm serogroup B (NmB) vaccine based on native outer membrane vesicles (NOMV) with genetically attenuated endotoxin activity and over- expressed mutant Factor H binding protein (FHbp) with reduced FH binding. In both mice and infant macaques, the vaccine elicited much higher human complement-mediated serum bactericidal antibody (SBA) responses than a licensed NmB vaccine. The vaccine, NOMV-FHbp, also elicited SBA against Ng in mice and in infant macaques. We used anti-NOMV-FHbp antibodies to identify Ng antigens that are highly conserved between Nm and Ng. Our hypothesis is that an NOMV vaccine with over produced mutant FHbps from subfamilies A and B and conserved Nm/Ng antigens will elicit antibodies that provide broad protection against disease by both pathogens in all age groups. In Aim 1, we will use an engineered promoter to over produce mutant FHbps from subfamilies A and B and two or more highly conserved Ng antigens that elicit protective antibodies (NmNg-NOMV vaccine). In Aim 2, we will test the ability of NmNg-NOMV to prevent colonization and invasion in immortalized and primary nasal and cervical cell culture models. In Aim 3, we will test the ability of optimized NmNg-NOMV vaccines to prevent colonization and symptoms of disease in transgenic mouse models of meningococcal nasal colonization and meningitis and in a female estradiol-treated Tg mouse model of gonococcal vaginal colonization. Preventing colonization and invasion is important for providing individual protection against disease and preventing transmission between individuals (i.e. “community immunity”). The overall goal is development of an NOMV vaccine platform for expression of conserved Neisseria antigens with native structures that can elicit broadly protective antibodies against both pathogens. Successful development of an NmNg-NOMV vaccine would have a significant public health impact world-wide.


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: 2025 ( Subtotal = $0 )
2025	2024	OMVAX, INC.	1700 MONTGOMERY ST STE 108	SAN FRANCISCO	CA	94111	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	23	4/24/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $373,730 )
2024	2024	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	23	5/20/2024	NON-COMPETING CONTINUATION	$37,373
2024	2024	OMVAX INC	1700 OWENS ST	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	23	2/27/2024	NON-COMPETING CONTINUATION	$336,357
														Subtotal = $373,730

Issue Date FY: 2023 ( Subtotal = $373,730 )
2023	2023	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	22	2/2/2023	NON-COMPETING CONTINUATION	$373,730
														Subtotal = $373,730

Issue Date FY: 2022 ( Subtotal = $373,730 )
2022	2022	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	21	1/14/2022	NON-COMPETING CONTINUATION	$373,730
2022	2020	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	18	12/6/2021	COMPETING CONTINUATION	$0
														Subtotal = $373,730

Issue Date FY: 2021 ( Subtotal = $373,730 )
2021	2021	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	002	20	9/10/2021	NON-COMPETING CONTINUATION	$373,730
2021	2020	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	001	18	4/14/2021	COMPETING CONTINUATION	$18,683
2021	2018	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	17	4/14/2021	NON-COMPETING CONTINUATION	-$18,683
														Subtotal = $373,730

Issue Date FY: 2020 ( Subtotal = $434,518 )
2020	2020	OMVAX, INC.	1700 OWENS ST STE 515	SAN FRANCISCO	CA	94158	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	003	19	9/10/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$292,679
2020	2020	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	001	18	1/23/2020	COMPETING CONTINUATION	$654,028
2020	2020	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	002	18	9/10/2020	COMPETING CONTINUATION	-$512,189
2020	2018	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	17	1/15/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $434,518

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	17	12/14/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $641,748 )
2018	2018	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	17	6/5/2018	NON-COMPETING CONTINUATION	$641,748
														Subtotal = $641,748

Issue Date FY: 2017 ( Subtotal = $641,748 )
2017	2017	CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND	747 52ND ST	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	16	7/5/2017	NON-COMPETING CONTINUATION	$641,748
														Subtotal = $641,748

Issue Date FY: 2016 ( Subtotal = $641,748 )
2016	2016	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	15	6/23/2016	NON-COMPETING CONTINUATION	$641,748
														Subtotal = $641,748

Issue Date FY: 2015 ( Subtotal = $641,748 )
2015	2015	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	14	6/24/2015	NON-COMPETING CONTINUATION	$641,748
														Subtotal = $641,748

Issue Date FY: 2014 ( Subtotal = $672,223 )
2014	2014	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	13	6/30/2014	COMPETING CONTINUATION	$672,223
2014	2013	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	001	12	6/30/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $672,223

Issue Date FY: 2013 ( Subtotal = $550,570 )
2013	2013	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	12	5/13/2013	NON-COMPETING CONTINUATION	$550,570
														Subtotal = $550,570

Issue Date FY: 2012 ( Subtotal = $631,670 )
2012	2012	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	11	5/15/2012	NON-COMPETING CONTINUATION	$631,670
														Subtotal = $631,670

Issue Date FY: 2011 ( Subtotal = $651,283 )
2011	2011	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	10	6/23/2011	NON-COMPETING CONTINUATION	$651,283
														Subtotal = $651,283

Issue Date FY: 2010 ( Subtotal = $604,832 )
2010	2010	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	9	5/24/2010	NON-COMPETING CONTINUATION	$604,832
														Subtotal = $604,832

Issue Date FY: 2009 ( Subtotal = $587,866 )
2009	2009	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	8	6/11/2009	COMPETING CONTINUATION	$587,866
														Subtotal = $587,866

Issue Date FY: 2007 ( Subtotal = $594,344 )
2007	2007	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	7	1/12/2007	NON-COMPETING CONTINUATION	$594,344
														Subtotal = $594,344

Issue Date FY: 2006 ( Subtotal = $600,614 )
2006	2006	CHILDRENS HOSP. & RESEARCH CTR OF OAKLAND	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	6	1/25/2006	NON-COMPETING CONTINUATION	$600,614
														Subtotal = $600,614

Issue Date FY: 2005 ( Subtotal = $603,651 )
2005	2005	CHILDRENS HOS. MED. CTR. OF NORTHERN CA	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Microbiology and Infectious Diseases Research	000	5	1/17/2005	NON-COMPETING CONTINUATION	$603,651
														Subtotal = $603,651

Issue Date FY: 2004 ( Subtotal = $602,069 )
2004	2004	CHILDRENS HOS. MED. CTR. OF NORTHERN CA	747 52ND STREET	OAKLAND	CA	94609	ALAMEDA	USA	Microbiology and Infectious Diseases Research	000	4	1/26/2004	COMPETING CONTINUATION	$602,069
														Subtotal = $602,069

Grand Total All Awards = $12,100,074

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Meningococcal and gonococcal vaccine to prevent invasive disease and carriage

Award Number: R01AI046464

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: 07/05/2000

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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