Tuesday, May 13, 2025 5/13/2025

Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus

Award Number: R01AI141603
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus - PROJECT SUMMARY / ABSTRACT Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus Despite the worldwide licensure and availability of two rotavirus vaccines in 2006, it is estimated that rotavirus kills approximately 215,000 children each year. Children under the age of 5 in developing countries are significantly more likely to be affected by severe rotavirus disease as the currently available vaccines have lower efficacy (50-60%) as compared to developed nations (>85%). The ongoing morbidity and mortality as well as the risk posed by current live-attenuated vaccines, necessitate the development of a next generation human rotavirus vaccine. We have developed an orally-delivered, mucosal vaccine platform that employs Lactobacillus acidophilus. We have brought together innovative adjuvant and antigen-expression strategies in unique constructs with demonstrated potential to induce robust mucosal and systemic immune responses. This platform offers several important feasibility advantages as it employs a commensal designated as GRAS (generally regarded as safe) by the FDA, is inexpensive to produce, does not require cold-chain, and is needleless. We will utilize a novel CRISPR-Cas9 system adapted to L. acidophilus to engineer sophisticated vaccine constructs that will be tested using a homotypic mouse rotavirus challenge. Induction of homotypic and heterotypic neutralizing antibodies will be assessed using a novel, highly sensitive assay. We will assess vaccine strain colonization and potential off-target effects on the microbiome. Finally, we will perform a direct comparison of our rLA rotavirus vaccine against a human live attenuated vaccine in the gnotobiotic pig model using animals transplanted with human infant fecal microbiome. Efficacy against human rotavirus challenge will be determined. At the completion of these proposed studies, we aim to have a rLA construct ready to proceed toward human clinical trials.


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 = $720,054 )
2024	2024	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	5	5/16/2024	NON-COMPETING CONTINUATION	$72,005
2024	2024	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	5	12/4/2023	NON-COMPETING CONTINUATION	$648,049
														Subtotal = $720,054

Issue Date FY: 2023 ( Subtotal = $758,912 )
2023	2023	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	4	12/1/2022	NON-COMPETING CONTINUATION	$758,912
														Subtotal = $758,912

Issue Date FY: 2022 ( Subtotal = $690,515 )
2022	2022	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	3	11/9/2021	NON-COMPETING CONTINUATION	$679,126
2022	2022	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	3	11/10/2021	SUPPLEMENT FOR EXPANSION	$11,389
														Subtotal = $690,515

Issue Date FY: 2021 ( Subtotal = $681,022 )
2021	2021	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	2	5/13/2021	NON-COMPETING CONTINUATION	$0
2021	2021	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	2	12/4/2020	NON-COMPETING CONTINUATION	$681,022
														Subtotal = $681,022

Issue Date FY: 2020 ( Subtotal = $700,593 )
2020	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	1	6/24/2020	SUPPLEMENT FOR EXPANSION	$9,137
2020	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	1	12/13/2019	NEW	$691,456
2020	2020	COLORADO STATE UNIVERSITY	601 S HOWES ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	002	1	9/16/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $700,593

Grand Total All Awards = $3,551,096

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Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus

Award Number: R01AI141603

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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