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Multivalent Toxoid Vaccine for recurrent Staphylococccus aureus disease

Award Number: R01AI111205
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: 08/01/2014
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Multivalent Toxoid Vaccine for recurrent Staphylococccus aureus disease - Project Summary Staphylococcus aureus (S. aureus; SA) is a major public health threat causing a variety of diseases from the skin and soft tissue infections (SSTI), comprising over 90% of infections, to invasive and life-threatening infections, the major cause of SA mortality. The problem is further exacerbated by growing antibiotic resistance and a lack of a vaccine. SA has a remarkable ability to evade and manipulate immune responses through a range of virulence factors, including a plethora of toxins, mainly the pore-forming toxins (PFTs) and superantigens (SAgs). Several SA surface antigen vaccines were tested in human efficacy trials and all have failed. There is a profound knowledge gap about the nature of a protective immune response to SA infection. In the past 10-15 years, we have learned that using staphylococcal surface antigens to enhance opsonophagocytic clearance is not a viable strategy against SA, and response to cell-associated antigens can trigger deleterious immune responses. Antitoxin antibodies and an effective T cell response are critical for protection against SA infection. Neutralizing antibodies against key SA toxins, primarily PFTs, and SAgs, correlate with better clinical outcomes. Under the prior R01 preceding this renewal application, we developed a multi-component vaccine, IBT-V02, and demonstrated its efficacy in multiple models including primary and recurrent SSTI. IBT-V02 received further funding from CARB-X and a VC firm for advanced development and is now scheduled to enter Phase 1 clinical trial in 2022. We intend to evaluate the efficacy of the vaccine against recurrent SSTI in a follow- on Phase 2/3 trial in patients presenting with a primary SA-SSTI. In the current renewal application, we will test the hypothesis, in humans, that neutralizing PFTs and SAgs reduce the rate of recurrent SA-SSTI by protecting tissues, innate immune cells, and T cells from the cytolytic and immune-modulatory effects of these toxins. In Aim 1, we will conduct a clinical study at Olive View-UCLA emergency Department with longitudinal sampling of patients presenting with SA-SSTI over a one-year period with monitoring for possible recurrence. This study will provide an accurate estimate of the rate of recurrence with a tightly defined case definition and, for the first time, provide longitudinal microbiological and immunological samples during and after a primary infection through the time of recurrence. In Aim 2, the bacterial isolates and longitudinal immunological samples will be characterized, and the relationship between immunological markers and probability of recurrence will be analyzed by state-of- the-art statistical methodologies. In Aim 3, using humanized mouse models and cytokine reporter mice, we will test the hypothesis that neutralization of PFTs and SAgs will enable the host to mount effective Th17 and γδ T cell responses. A highly experienced team of vaccine development experts, clinicians, and immunologists with decades of experience with SA and biostatistics experts with an extensive track record has been assembled to address these questions. The result of this study will elevate our understanding of basic immunology of staphylococcal infections and also inform clinical development of urgently needed vaccines for this pathogen.


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 = $697,200 )
2026	2026	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	10	2/19/2026	NON-COMPETING CONTINUATION	$697,200
														Subtotal = $697,200

Issue Date FY: 2025 ( Subtotal = $646,138 )
2025	2025	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	9	2/13/2025	NON-COMPETING CONTINUATION	$646,138
														Subtotal = $646,138

Issue Date FY: 2024 ( Subtotal = $619,937 )
2024	2024	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	8	3/28/2024	NON-COMPETING CONTINUATION	$649,379
2024	2023	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	7	3/25/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$29,442
2024	2023	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	7	2/14/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$209,734
2024	2022	INTEGRATED BIOTHERAPEUTICS, LLC	4 RESEARCH CT STE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	6	2/14/2024	COMPETING CONTINUATION	-$209,734
														Subtotal = $619,937

Issue Date FY: 2023 ( Subtotal = $700,012 )
2023	2023	ABVACC, INC.	4 RESEARCH CT	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	7	5/10/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$700,012
2023	2022	INTEGRATED BIOTHERAPEUTICS INC	4 RESEARCH CT	POTOMAC	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	6	5/10/2023	COMPETING CONTINUATION	$0
														Subtotal = $700,012

Issue Date FY: 2022 ( Subtotal = $2,998,420 )
2022	2022	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	6	3/14/2022	COMPETING CONTINUATION	$702,876
2022	2019	INTEGRATED BIOTHERAPEUTICS INC	4 RESEARCH CT	POTOMAC	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	5	9/8/2022	NON-COMPETING CONTINUATION	$761,761
2022	2018	INTEGRATED BIOTHERAPEUTICS INC	4 RESEARCH CT	POTOMAC	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	4	9/8/2022	NON-COMPETING CONTINUATION	$775,672
2022	2017	INTEGRATED BIOTHERAPEUTICS INC	4 RESEARCH CT	POTOMAC	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	3	9/8/2022	NON-COMPETING CONTINUATION	$758,111
														Subtotal = $2,998,420

Issue Date FY: 2021 ( Subtotal = -$3,486,882 )
2021	2019	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	004	5	7/6/2021	NON-COMPETING CONTINUATION	-$761,776
2021	2018	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	4	7/6/2021	NON-COMPETING CONTINUATION	-$775,672
2021	2017	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	3	7/6/2021	NON-COMPETING CONTINUATION	-$758,111
2021	2016	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	7/6/2021	NON-COMPETING CONTINUATION	-$779,398
2021	2015	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	7/6/2021	NEW	-$411,925
														Subtotal = -$3,486,882

Issue Date FY: 2019 ( Subtotal = $761,776 )
2019	2019	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	12/21/2018	NON-COMPETING CONTINUATION	$761,776
														Subtotal = $761,776

Issue Date FY: 2018 ( Subtotal = $775,672 )
2018	2018	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	12/12/2017	NON-COMPETING CONTINUATION	$775,672
														Subtotal = $775,672

Issue Date FY: 2017 ( Subtotal = $758,111 )
2017	2017	INTEGRATED BIOTHERAPEUTICS, INC.	4 RESEARCH COURT, SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	11/29/2016	NON-COMPETING CONTINUATION	$758,111
														Subtotal = $758,111

Issue Date FY: 2016 ( Subtotal = $779,398 )
2016	2016	INTEGRATED BIOTHERAPEUTICS INC	4539 METROPOLITAN COURT	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	2	12/18/2015	NON-COMPETING CONTINUATION	$779,398
														Subtotal = $779,398

Issue Date FY: 2015 ( Subtotal = $411,925 )
2015	2015	INTEGRATED BIOTHERAPEUTICS INC	4539 METROPOLITAN COURT	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	001	1	2/4/2015	NEW	$102,044
2015	2015	INTEGRATED BIOTHERAPEUTICS INC	4539 METROPOLITAN COURT	FREDERICK	MD	21704	FREDERICK	USA	Allergy and Infectious Diseases Research	000	1	12/31/2014	NEW	$309,881
														Subtotal = $411,925

Grand Total All Awards = $5,661,707

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Multivalent Toxoid Vaccine for recurrent Staphylococccus aureus disease

Award Number: R01AI111205

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: 08/01/2014

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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