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A versatile new generation platform for prophylactic treatment against highly consequential bacterial pathogens: Yersinia pestis as a prototype

Award Number: R01AI190007
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: 09/08/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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A versatile new generation platform for prophylactic treatment against highly consequential bacterial pathogens: Yersinia pestis as a prototype - ABSTRACT Among the seven deadliest pandemics recorded in history, three were caused by Y. pestis (Yp), the etiological agent of bubonic and pneumonic plague. The organism continues to cause global outbreaks with a recent one of pneumonic plague in Madagascar having a case fatality rate of 8.6%. Subunit plague vaccines based on two immunogens, the capsular antigen (F1) and a type 3 secretion system (T3SS) component, low calcium response V antigen (LcrV), have been tested for eliciting protective immune responses in various animal models of bubonic and pneumonic plague. Consequently, limited phase I and II clinical trials with F1-V vaccines in conjunction with adjuvants have been conducted, but no lead candidate has entered phase III trials or been approved by the FDA. During the 2023 and 2025 WHO global consultation meetings, it was reiterated to bring novel preclinical plague vaccine candidates under development into the clinics as Yp is among the top 5 pandemic-causing pathogens for which countermeasures must be developed. We have shown that the addition of a third antigen, Yersinia secretory protein, YscF, which constitutes the needle of the T3SS injectisome, to F1-V in adenovirus 5- and bacteriophage T4-based plague vaccines has an added protective advantage. Complete protection was observed with Ad5-YFV and T4-YFV vaccines in mouse, rat, and/or non-human primate (NHP) models of bubonic and pneumonic plague, with the generation of robust immune responses, against capsulated and non- capsulated Yp strains. In contrast, the F1-V-based vaccines only provided partial protection against the naturally occurring non-capsulated strains. Leveraging the revolutionary potential of mRNA-lipid nanoparticle (mRNA- LNP) technology, we propose to develop a new generation broadly protective mRNA-LNP-based trivalent (YFV) vaccine using our proprietary thermostable lung-targeted LNPs. Generating bacterial vaccines employing this type of platform is still an uncharted territory, requiring mRNA adaptations for expression in the mammalian host. As proof, we have developed the first F1-mRNA-LNP vaccine which is 100% efficacious against bubonic plague in mice when administered in a single dose. We hypothesize that the following aims will bridge knowledge gaps in our understanding of the immunomodulatory potential of this platform for vaccine development against highly consequential bacterial pathogens. Three aims have been proposed. Aim 1 will design, construct, and rank YFV mRNA-LNP vaccine candidates which provide an optimal protective immune response in a murine bubonic plague model. Aim 2 will assess comprehensive immune responses and protective efficacy of the selected plague vaccine candidates against pneumonic plague in mice and rats using capsulated and non-capsulated Yp CO92 strains. In Aim 3, the durability of immune responses and protective efficacy of the most efficacious plague vaccine will be tested in a pneumonic NHP model. By integrating cutting-edge technologies, we would develop a thermostable plague vaccine. Our team of experts in plague, vaccine design, and animal models along with stellar biocontainment facilities will lead to rapid transition of a novel plague vaccine to the clinics.


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: 2026 ( Subtotal = $517,568 )
2026	2026	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Allergy and Infectious Diseases Research	000	1	9/8/2026	NEW	$517,568
														Subtotal = $517,568

Grand Total All Awards = $517,568

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A versatile new generation platform for prophylactic treatment against highly consequential bacterial pathogens: Yersinia pestis as a prototype

Award Number: R01AI190007

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: 09/08/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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