Development of mecvax, a cross protective subunit vaccine for etec

Active Project Grant Awarded Last action

Award ID
R01AI177144
Recipient
Awarding agency
Obligated
$8,045,890

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 68% complete
Place of performance
Urbana, IL 61801, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Diarrhea is the second leading cause of death in children aged 220 million diarrhea clinical cases annually, resulting in stunting and poor cognitive development in diarrheal children, 1,065,000 years lost due to disability (YLD), 6,894,000 years to disability-adjusted life-years (daly), and about 100,000 deaths (many are children < 5 years). Etec is also a primary cause of diarrhea in young animals and causes significant economic losses worldwide. Currently, there are no licensed vaccines against etec diarrhea. The development of effective vaccines for etec is a top priority for who, unicef, and many other public health institutions. By applying an innovative vaccinology platform, we have constructed two polyvalent proteins and developed a protein-based multivalent etec vaccine candidate, mecvax. Mecvax is the only etec vaccine candidate that induces protective antibodies against both etec toxins (LT and STA) and the seven most important etec adhesins (CFA/i, CS1 - CS6). Since etec bacteria producing LT and/or STA toxin are associated with all etec diarrhea cases and strains expressing adhesin CFA/i or CS1 - CS6 cause > 66% of etec clinical cases, the synergy of antitoxin and anti-adhesin immunity from mecvax provides truly broad protection against etec children's diarrhea and travelers' diarrhea. Mecvax is demonstrated to broadly protect against etec clinical diarrhea and colonization of small intestines preclinically. The central goal of this milestone-oriented vaccine development project is to optimize mecvax vaccine formulation, analytical development, and production processing. The rationale is that the completion of this application will identify mecvax optimal formulation, optimize upstream and downstream processing and analytical development, and manufacture vaccine cglp products, - essential to accelerate mecvax development. To achieve these goals, we will 1) evaluate mecvax protection against etec adherence and enterotoxicity at different antigen doses, adjuvants, buffers, and shelving conditions, 2) optimize analytical assays and upstream and downstream processing, 3) manufacture and test mecvax master cell banks, and 4) perform product production engineering runs and submit mecvax pre-IND application. The positive impact is that an effective etec vaccine will save nearly 100,000 lives and prevent >200 million diarrheal clinical cases each year, and reduce long-term negative nutritional and developmental impacts.

Transactions

Action Obligated Date
Amendment $1,123,353
Amendment $1,129,161
Amendment $1,140,647
Amendment $1,140,647
Amendment $0
Amendment $0
Amendment $0
Amendment $1,170,694
Amendment $1,170,694
Original award $1,170,694

Subawards

Subrecipient Amount Awarded
The Johns Hopkins University Development of MecVax, a cross protective subunit vaccine for ETEC $47,820
Advanced Bioscience Laboratories, Inc. $472,844
Advanced Bioscience Laboratories, Inc. $582,093
The Johns Hopkins University $47,820
The Johns Hopkins University $47,820
Advanced Bioscience Laboratories, Inc. $564,446
Advanced Bioscience Laboratories, Inc. $384,355
The Johns Hopkins University $47,820

Quick answers

Who received award R01AI177144?

R01AI177144 was awarded to University Of Illinois by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on June 1, 2023.

How much is award R01AI177144 worth?

$8,045,890 has been obligated on R01AI177144.

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