# Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus

> **NIH NIH R01** · COLORADO STATE UNIVERSITY · 2020 · $9,137

## Abstract

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.

## Key facts

- **NIH application ID:** 10113452
- **Project number:** 3R01AI141603-01A1S1
- **Recipient organization:** COLORADO STATE UNIVERSITY
- **Principal Investigator:** Zaid Abdo
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $9,137
- **Award type:** 3
- **Project period:** 2020-05-18 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113452

## Citation

> US National Institutes of Health, RePORTER application 10113452, Novel recombinant Rotavirus vaccine utilizing the probiotic microorganism Lactobacillus acidophilus (3R01AI141603-01A1S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10113452. Licensed CC0.

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