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Generation and Evaluation of Pro-Apoptotic rBCG and Viral Vectors as TB Vaccine C

Award Number: R01AI090691
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: 08/01/2010
PERIOD OF PERFORMANCE END DATE: 03/31/2014

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Generation and Evaluation of Pro-Apoptotic rBCG and Viral Vectors as TB Vaccine C - DESCRIPTION (provided by applicant): Killing nearly 2 million people a year, TB is one of the leading causes of infectious disease deaths globally. In 2007, there were an estimated 9.27 million cases of TB. Co-infection with HIV and an increase in drug-resistant strains of TB are making the epidemic even more severe and complicated to address. The current TB vaccine, BCG, is almost 90 years old and has been ineffective in saving the millions of lives lost to TB each year. Aeras Global TB Vaccine Foundation is a non-profit Product Development Partnership working in collaboration with leading researchers and scientists from the academic, industry, non-profit and government sectors to develop new and effective vaccine regimens to stop TB. An increasingly well documented defect in the BCG vaccine lies in its inability to escape the phagolysosome of infected macrophages and dendritic cells, which, unlike M. tuberculosis or M. leprae, diverts the immune response to primarily MHC class II antigen presentation and is the likely reason for the CD4 dominant T cell response to vaccination. Loss and gain of function screens using M. tuberculosis and the related avirulent M. kansasii have identified specific genes present in Mtb complex organisms, including BCG, whose gene products function to inhibit apoptosis of infected macrophages. Aeras will create fully cGxP compliant recombinant BCG vaccines incorporating deletions in genes known to inhibit apoptosis to enhance immune responses by cross-priming and will also construct cGxP compliant booster vaccines encoding and expressing high valency CD8+ T cell immunogens to create an optimal tuberculosis vaccine regimen. The booster vaccines will consist of recombinant adenovirus serotype 4 and recombinant human CMV vectors, both of which have been shown to elicit potent CD8+ T cell responses. We will evaluate these regimens in mice and rhesus macaques, models of TB vaccine immunology and efficacy with which we have extensive experience, to expediently select an optimal regimen.


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: 2014 ( Subtotal = $0 )
2014	2012	AERAS GLOBAL TB FOUNDATION	1405 RESEARCH BLVD SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	2/20/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $619,046 )
2012	2012	AERAS GLOBAL TB FOUNDATION	1405 RESEARCH BLVD SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	7/26/2012	NON-COMPETING CONTINUATION	$619,046
														Subtotal = $619,046

Issue Date FY: 2011 ( Subtotal = $131,388 )
2011	2011	AERAS GLOBAL TB FOUNDATION	1405 RESEARCH BLVD SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	8/9/2011	NON-COMPETING CONTINUATION	$131,388
														Subtotal = $131,388

Issue Date FY: 2010 ( Subtotal = $94,727 )
2010	2010	AERAS GLOBAL TB FOUNDATION	1405 RESEARCH BLVD SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	7/25/2010	NEW	$94,727
2010	2010	AERAS GLOBAL TB FOUNDATION	1405 RESEARCH BLVD SUITE 300	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	1	7/30/2010	NEW	$0
														Subtotal = $94,727

Grand Total All Awards = $845,161

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Generation and Evaluation of Pro-Apoptotic rBCG and Viral Vectors as TB Vaccine C

Award Number: R01AI090691

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: 08/01/2010

PERIOD OF PERFORMANCE END DATE: 03/31/2014

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