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Quantifying the Breadth and Duration of Immunity Induced by Meningococcal B Vaccines

Award Number: R01AI132496
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: 01/01/2018
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Quantifying the Breadth and Duration of Immunity Induced by Meningococcal B Vaccines - Project Summary/Abstract Meningococcal disease caused by the bacterial pathogen Neisseria meningitidis is responsible for significant morbidity and mortality worldwide. Preventing meningococcal disease is of particular public health importance because of the sudden onset of symptoms, rapid progression, and high case fatality even among previously healthy individuals. Serogroup B meningococcal (MenB) disease has caused outbreaks in multiple countries and the US, where several outbreaks occurred on college campuses in recent years. Teens and young adults are one of the groups at highest risk of invasive disease. In 2014 and 2015, two novel MenB vaccines, Bexsero (4CMenB, GSK) and Trumenba (rLP2086, Pfizer) were licensed in the US for 10-25 year olds. The extent to which these vaccines induce broadly protective, persistent immunity is unknown, limiting our ability to understand the kinetics of the immune response and to develop optimal vaccination strategies. In addition, no studies have evaluated these two vaccines using the same measures of immunity against the same disease-causing MenB isolates. We aim to advance the field of vaccinology and to improve efforts to prevent deadly cases of MenB disease by evaluating both the short-term and long-term immunogenicity of these MenB vaccines and by investigating the breadth of immunity induced against the diversity of MenB strains that cause disease. To achieve these aims, we will conduct clinical epidemiological research using a novel serum bank that we collected from teens and young adults during two of the first studies of Bexsero immunogenicity in the US, and we will extend the period of follow up among this unique cohort. In addition, we will use similar methods to enroll young adults into a prospective longitudinal study to evaluate Trumenba immunity. To evaluate immune responses, we will conduct serum bactericidal antibody assays using externally-derived human complement (hSBA) and a recently developed serum bactericidal antibody assay using intrinsic human complement (iSBA) to investigate how broadly immunogenic both vaccines are against a collection of dozens of MenB isolates and whether immunity persists long term. We will then develop statistical models to evaluate hSBA and iSBA responses and the relationship between these markers of functional immunity over time. We aim to rigorously and simultaneously evaluate Bexsero and Trumenba vaccine- induced immunity against the same panel of MenB strains. Meningococcal B vaccines are critical tools for the prevention of invasive meningococcal disease. Our research will combine new epidemiologic data, novel laboratory methods, and statistical models to generate urgently needed evidence that will increase our understanding of vaccine-induced immunity. Our results can be used to inform vaccination policy so that effective, targeted vaccination strategies can be designed and implemented.


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 = -$13,608 )
2025	2023	THE ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING	845 ST SHERBROOKE W	MONTREAL	QC			CAN	Allergy and Infectious Diseases Research	000	5	5/7/2025	NON-COMPETING CONTINUATION	-$13,608
														Subtotal = -$13,608

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ			CAN	Allergy and Infectious Diseases Research	000	5	12/12/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $508,634 )
2023	2023	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ			CAN	Allergy and Infectious Diseases Research	000	5	12/23/2022	NON-COMPETING CONTINUATION	$508,634
														Subtotal = $508,634

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ			CAN	Allergy and Infectious Diseases Research	000	4	2/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $513,272 )
2021	2021	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ			CAN	Allergy and Infectious Diseases Research	000	4	12/16/2020	NON-COMPETING CONTINUATION	$513,272
														Subtotal = $513,272

Issue Date FY: 2020 ( Subtotal = $532,647 )
2020	2020	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ	H3A 0G4		CAN	Allergy and Infectious Diseases Research	003	3	5/12/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$528,627
2020	2020	ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING / MCGILL	845 RUE SHERBROOKE O	MONTREAL	PQ	H3A 0G4		CAN	Allergy and Infectious Diseases Research	000	3	2/6/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$532,647
2020	2019	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Allergy and Infectious Diseases Research	001	2	2/7/2020	NON-COMPETING CONTINUATION	$0
2020	2019	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Allergy and Infectious Diseases Research	002	2	5/12/2020	NON-COMPETING CONTINUATION	-$528,627
														Subtotal = $532,647

Issue Date FY: 2019 ( Subtotal = $718,641 )
2019	2019	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Allergy and Infectious Diseases Research	000	2	12/24/2018	NON-COMPETING CONTINUATION	$718,641
														Subtotal = $718,641

Issue Date FY: 2018 ( Subtotal = $784,845 )
2018	2018	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Allergy and Infectious Diseases Research	000	1	12/27/2017	NEW	$784,845
														Subtotal = $784,845

Grand Total All Awards = $3,044,431

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Quantifying the Breadth and Duration of Immunity Induced by Meningococcal B Vaccines

Award Number: R01AI132496

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: 01/01/2018

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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