Ho, Yen-Linh Thi, Hynes, Daniel, Martina, Yuri, Love, Bill, Horwell, Ed, Xu, Rong 
ORCID: 0009-0005-8895-0303, Kadioglu, Aras ORCID: 0000-0003-1137-6321, Vo, Linh, Hong, Huynh A, Nguyen, Linh Hanh et al (show 1 more authors)
(2024)
Intranasal administration of DSM 32444 Bacillus subtilis spores: safety and tolerability
JOURNAL OF MEDICAL MICROBIOLOGY, 73 (7).
ISSN 0022-2615, 1473-5644
Abstract
Introduction. Administered nasally, spores of the Gram-positive bacterium Bacillus subtilis have been shown to be able to induce innate immunity sufficient to confer protection to influenza and respiratory syncytial virus. Hypothesis. Although members of the aerobiome, intranasal delivery of high numbers of live spores carries potential safety issues. Aim. To address the potential safety risk of using live spores, we assessed the safety of spores that had been completely inactivated using heat sterilization. Methodology. Using autoclaved, and therefore killed, spores of a generally recognized as safe-notified B. subtilis strain (DSM 32444), safety was assessed in vitro (biotype, genome and cell based cytoxicity) and in vivo, using intranasal administration in rodent models and lastly in human volunteers. Results. Using a 15-day, repeat-dose, regimen in a rodent model, no indication of toxicity was observed. In a registered human study (NCT05984004), a formulated preparation of inactivated DSM 32444 spores referred to as SPEROVID was developed, and tolerance in human volunteers was assessed following 7 days of nasal dosing (2-4 times/day). Conclusion. Our study demonstrated that in humans an intranasal dose of up to 3×108 killed spores was safe and well tolerated.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Bacillus, intranasal, innate immunity, spores. |
| Divisions: | Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Infection, Vet & Ecological Sciences Faculty of Health & Life Sciences > Inst. Infection, Vet & Ecological Sciences > Inst. Infection, Vet & Ecological Sciences (T&R Staff) Faculty of Health & Life Sciences > Inst. Infection, Vet & Ecological Sciences > Clinical Infection, Microbiology & Immunology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 01 Dec 2025 08:35 |
| Last Modified: | 13 Jun 2026 05:48 |
| DOI: | 10.1099/jmm.0.001845 |
| Open Access URL: | https://www.microbiologyresearch.org/content/journ... |
| Related Websites: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3195702 |
| Disclaimer: | The University of Liverpool is not responsible for content contained on other websites from links within repository metadata. Please contact us if you notice anything that appears incorrect or inappropriate. |
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