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The development of a recombinant vaccine against human onchocerciasis

Award Number: R01AI078314
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: 08/25/2009
PERIOD OF PERFORMANCE END DATE: 02/29/2024

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The development of a recombinant vaccine against human onchocerciasis - ABSTRACT Human onchocerciasis (ONCHO) is a major cause of infectious blindness, skin disease, and chronic disability, infecting many millions worldwide99% in Sub-Saharan Africaand resulting in widespread vision impairment and blindness. Caused by the filarial nematode Onchocerca volvulus (Ov), attempts to eliminate this neglected tropical disease via annual mass drug administration (MDA) with donated ivermectin (IVM) have proved largely ineffective, decreasing its incidence only 31% in the last 20 years. Optimists call for an additional 1.15 billion treatments to achieve elimination by 2045. Mathematical modelling and expert opinions are more pessimistic, indicating that ONCHO in Africa cannot be eliminated solely through MDA with IVM. Supporting their viewpoint is that IVM cannot be administered safely in Central Africa where the disease is co-endemic with Loa loa infections, and early evidence points to the possible emergence of IVM drug resistance. New tools are needed, such as a preventive vaccine to accelerate ONCHO elimination. Our goal is to develop a safe and effective prophylactic vaccine to protect vulnerable populations of children <5 living in endemic areas against Ov infections. Reducing the adult worm burden and possibly also fecundity will inexorably reduce microfilaridermia and pathology. The vaccine could also contribute to lower transmission rates and protect areas where local elimination may have been achieved, thus lowering the number of annual MDA with IVM, forestalling drug resistance, and ensuring the success of the existing MDA. We have already identified 2 Ov protective vaccine antigens (Ov-103 and Ov-RAL-2) with a proven production pathway and with efficacy in 2 small-animal models; they were protective as monovalent vaccines, and their efficacy was enhanced when the two monovalent vaccines were co-administered in separate locations (i.e. ONCHO vaccine). We seek now to leverage these achievements by advancing to the next stage on the critical path to Ov vaccine development. Our hypothesis is that an optimal ONCHO vaccine formulation can be identified by further employing the mouse model before testing it in naïve calves against a natural infection with O. ochengi, an infection system with a closely related parasite known to mimic immunologically the status of humans living in regions endemic for Ov. Notably, both vaccine antigens pose minimal risk of generating atopic responses in children <5 years of age who are naturally exposed to ONCHO; neither elicits significant functional IgE responses. We have 2 specific aims for meeting our goal: (1) Test in naïve calves under field conditions the efficacy of two ONCHO vaccine formulations against O. ochengi infection. (2) Establish immune correlates and mechanisms associated in mice with protective immunity induced by two ONCHO vaccine formulations. Ascertaining which of the 2 adjuvanted ONCHO vaccines (formulated with alum or with Advax-2 with or without alum) is more efficacious in the vaccinated calves, and the parallel elucidation of their immune correlates in the bovine and mouse models will position us to move the optimal ONCHO vaccine formulation to first-in-human trials.


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 = -$94 )
2024	2021	NEW YORK BLOOD CENTER, INC	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	10	9/18/2024	NON-COMPETING CONTINUATION	-$94
														Subtotal = -$94

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	NEW YORK BLOOD CENTER, INC.	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	10	1/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $775,846 )
2021	2021	NEW YORK BLOOD CENTER, INC.	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	10	2/11/2021	NON-COMPETING CONTINUATION	$711,118
2021	2021	NEW YORK BLOOD CENTER, INC.	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	001	10	8/27/2021	NON-COMPETING CONTINUATION	$64,728
														Subtotal = $775,846

Issue Date FY: 2020 ( Subtotal = $684,875 )
2020	2020	NEW YORK BLOOD CENTER, INC., THE	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	9	2/25/2020	NON-COMPETING CONTINUATION	$684,875
														Subtotal = $684,875

Issue Date FY: 2019 ( Subtotal = $683,255 )
2019	2019	NEW YORK BLOOD CENTER, INC., THE	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	8	1/25/2019	NON-COMPETING CONTINUATION	$683,255
														Subtotal = $683,255

Issue Date FY: 2018 ( Subtotal = $694,825 )
2018	2018	NEW YORK BLOOD CENTER, INC., THE	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	7	2/16/2018	NON-COMPETING CONTINUATION	$694,825
														Subtotal = $694,825

Issue Date FY: 2017 ( Subtotal = $770,747 )
2017	2017	NEW YORK BLOOD CENTER, INC., THE	310 E 67TH ST	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	6	3/2/2017	COMPETING CONTINUATION	$770,747
														Subtotal = $770,747

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2013	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10021	NEW YORK	USA	Allergy and Infectious Diseases Research	000	5	7/30/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $603,776 )
2013	2013	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	5	7/22/2013	NON-COMPETING CONTINUATION	$603,776
														Subtotal = $603,776

Issue Date FY: 2012 ( Subtotal = $653,219 )
2012	2012	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	7/17/2012	NON-COMPETING CONTINUATION	$653,219
														Subtotal = $653,219

Issue Date FY: 2011 ( Subtotal = $679,506 )
2011	2011	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	7/25/2011	NON-COMPETING CONTINUATION	$679,506
														Subtotal = $679,506

Issue Date FY: 2010 ( Subtotal = $714,313 )
2010	2010	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	6/24/2010	NON-COMPETING CONTINUATION	$714,313
														Subtotal = $714,313

Issue Date FY: 2009 ( Subtotal = $708,326 )
2009	2009	New York Blood Center, Inc.	310 EAST 67TH STREET	NEW YORK	NY	10065	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	8/20/2009	NEW	$708,326
														Subtotal = $708,326

Grand Total All Awards = $6,968,594

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The development of a recombinant vaccine against human onchocerciasis

Award Number: R01AI078314

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: 08/25/2009

PERIOD OF PERFORMANCE END DATE: 02/29/2024

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