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MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled, Safety, Immunogenicity, and Dose-escalation Study in Adults with and without Latent Tuberculosis Infection in South Africa

Award Number: U01AI131861
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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MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled, Safety, Immunogenicity, and Dose-escalation Study in Adults with and without Latent Tuberculosis Infection in South Africa - Project Summary In 2014 there were an estimated 9.6 million cases of tuberculosis (TB) disease with 1.5 million deaths due to TB, more deaths than from any other single infectious agent. Bacille Calmette Guerin (BCG), a live attenuated Mycobacterium bovis (M.bovis), is the only licensed vaccine against TB. Although it is efficacious against severe forms of childhood TB when administered to newborn infants, it provides little or no protection against pulmonary TB in adolescents/adults, who are the major source of Mycobacterium tuberculosis (Mtb) transmission. It is pulmonary TB in these older age groups that drives the global epidemic. There is a critical need for TB research and development of new, improved tools, especially new and more effective TB vaccines, in order to reach the World Health Organization’s (WHO) goal of ending the TB epidemic by 2035 and achieving the similar United Nations (UN) Sustainable Development Goal of ending TB by 2030. Live-attenuated vaccination strategies may be the best approach for conferring durable T-cell immune responses, believed to be necessary for protecting against TB. MTBVAC is a novel, live-attenuated Mtb vaccine based on deletion of two independent genes encoding major virulence factors, but retaining Mtb genes not present in BCG. Because MTBVAC is based on live, attenuated Mtb, and therefore presents a wider collection of Mtb- specific antigens to the host immune system than BCG, it may provide better protection. We aim, in a Phase 1b/2a, double-blind, randomized, BCG-controlled, dose-ranging study, to evaluate MTBVAC in adults with and without prior Mtb infection (Latent TB Infection; LTBI) to obtain critical safety and immunogenicity data to guide dose selection and to facilitate the advancement of MTBVAC into efficacy trials in TB endemic countries. Participants will have received previous BCG vaccination in infancy. The primary endpoint is comparison of the safety profile of intradermal MTBVAC injection at each of four dose levels compared to BCG revaccination. The proposed trial will be conducted in South Africa which has the second highest annual TB incidence in the world (834 per 100,000). Investment in MTBVAC is important as it has 1) shown promising results 2) is the only live attenuated Mtb vaccine currently in clinical development (first in class) and 3) contains additional antigens to M.bovis, the progenitor of the current vaccine BGC, and therefore may provide enhanced protection against TB.


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 = -$157,873 )
2024	2019	INTERNATIONAL AIDS VACCINE INITIATIVE INC.	125 BROAD ST FL 9	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	001	4	4/17/2024	NON-COMPETING CONTINUATION	-$114,061
2024	2018	INTERNATIONAL AIDS VACCINE INITIATIVE INC.	125 BROAD ST FL 9	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	10/1/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$43,812
														Subtotal = -$157,873

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	5/23/2022	NON-COMPETING CONTINUATION	$0
2022	2019	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	002	4	8/1/2022	NON-COMPETING CONTINUATION	$0
2022	2018	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	001	3	5/23/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	9/16/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	000	4	7/21/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $162,368 )
2019	2019	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	002	4	9/5/2019	NON-COMPETING CONTINUATION	$131,886
2019	2018	AERAS	1405 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	4/18/2019	NON-COMPETING CONTINUATION	-$342,000
2019	2018	INTERNATIONAL AIDS VACCINE INITATIVE INC.	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	004	3	9/5/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$210,000
2019	2018	INTERNATIONAL AIDS VACCINE INITATIVE INC	125 BROAD ST FL 9TH	NEW YORK	NY	10004	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	4/16/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$372,482
2019	2017	AERAS	1405 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	1	9/5/2019	NEW	-$210,000
														Subtotal = $162,368

Issue Date FY: 2018 ( Subtotal = $342,000 )
2018	2018	AERAS	1405 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	7/30/2018	NON-COMPETING CONTINUATION	$342,000
														Subtotal = $342,000

Issue Date FY: 2017 ( Subtotal = $210,000 )
2017	2017	AERAS	1405 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	8/18/2017	NEW	$210,000
														Subtotal = $210,000

Grand Total All Awards = $556,495

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MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled, Safety, Immunogenicity, and Dose-escalation Study in Adults with and without Latent Tuberculosis Infection in South Africa

Award Number: U01AI131861

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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