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Controlled Infection Trial to Test Efficacy of Hookworm Vaccine with Different TLR Agonists

Award Number: U01AI129789
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract This U01 grant proposal will utilize a novel paradigm for the early assessment of vaccine efficacy and the selection of optimal vaccine formulation. We will conduct a Phase 2 clinical trial that enables the evaluation of an investigation hookworm vaccine by challenging human volunteers with a controlled human hookworm infection (CHHI) after vaccination. Hookworm is one of the most important parasitic infections, with over 500 million people infected worldwide, most with Necator americanus. The clinical hallmark of hookworm infection is iron deficiency anemia, resulting from intestinal blood loss directly caused by this parasite. Glutathione-S- Transferase-1 of N. americanus (Na-GST-1) is a component of the blood-feeding pathway of this intestinal helminth and was selected for clinical development based on its protective effect in animal studies. Recombinant Na-GST-1 formulated on Alhydrogel® has been shown to be safe when administered to healthy adults in Phase 1 trials in the USA and in hookworm endemic areas of Brazil and Gabon. In the proposed Phase 2 study, healthy hookworm‐naïve adult volunteers will be vaccinated with Na-GST-1/Alhydrogel® followed by challenging them with infective N. americanus larvae to determine the effect of vaccination on hookworm infection by parasitologic, hematologic, and immunologic parameters. Traditionally, proof-of-concept studies for investigational vaccines are conducted later in clinical development and usually in large field trials in pathogen endemic areas. These studies can take considerable time and involve large numbers of participants, depending on the incidence of the infection. The objective of this U01 proposal is to conduct a Phase 2 clinical trial in which proof-of-concept for this new vaccine for hookworm is tested early in clinical development and on a small number of volunteers. In addition, we will utilize state-of- the-art immunological technologies to comprehensively evaluate the humoral and cellular immune response to vaccination and how that translates into protection in the CHHI model. Hence, the proposed clinical trial will also serve to optimize the component combinations of the final vaccine formulation, especially the addition of novel Toll-Like Receptor immunostimulants such as GLA-AF and CpG. The results of this trial will permit critical decisions to be made on the further development of the Na-GST-1 hookworm vaccine and its final formulation, prior to conducting larger, more costly Phase 2 and 3 trials in hookworm endemic areas.


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 = -$1 )
2025	2022	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	5	11/26/2024	EXTENSION WITH OR WITHOUT FUNDS	-$1
														Subtotal = -$1

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	002	5	3/7/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2022	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	001	5	2/10/2023	EXTENSION WITH OR WITHOUT FUNDS	$188,037
2023	2022	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	003	5	4/19/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2020	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	4	2/10/2023	NON-COMPETING CONTINUATION	-$188,037
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $480,908 )
2022	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	5	5/1/2022	EXTENSION WITH OR WITHOUT FUNDS	$480,908
														Subtotal = $480,908

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	4	3/15/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $731,524 )
2020	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	001	4	4/29/2020	NON-COMPETING CONTINUATION	$731,524
2020	2019	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	3	1/31/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $731,524

Issue Date FY: 2019 ( Subtotal = $752,220 )
2019	2019	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	001	3	4/12/2019	NON-COMPETING CONTINUATION	$752,220
2019	2018	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	2	1/18/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $752,220

Issue Date FY: 2018 ( Subtotal = $855,527 )
2018	2018	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	002	2	9/6/2018	NON-COMPETING CONTINUATION	$0
2018	2018	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	001	2	9/5/2018	NON-COMPETING CONTINUATION	$52,316
2018	2018	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	2	4/11/2018	NON-COMPETING CONTINUATION	$803,211
														Subtotal = $855,527

Issue Date FY: 2017 ( Subtotal = $797,494 )
2017	2017	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Allergy and Infectious Diseases Research	000	1	4/26/2017	NEW	$797,494
														Subtotal = $797,494

Grand Total All Awards = $3,617,672

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Controlled Infection Trial to Test Efficacy of Hookworm Vaccine with Different TLR Agonists

Award Number: U01AI129789

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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