Journal
VACCINES
Volume 10, Issue 1, Pages -Publisher
MDPI
DOI: 10.3390/vaccines10010002
Keywords
SARS-CoV-2; COVID-19; oral vaccine; Bacillus subtilis; spike protein; sporulation
Categories
Funding
- Innovation and Technology Fund (ITF) [PRP/008/21FX]
- Institutional Development Scheme (IDS)-Research Infrastructure Grant (RIG) by the Hong Kong Research Grants Council [UGC/IDS(R)16/19]
- Institute of Chinese Medicine in The Chinese University of Hong Kong
- Hong Kong Metropolitan University
- Hong Kong certificated medicinal laboratories-Zentrogene Bioscience Laboratory Limited
- Health Plus Laboratory Limited
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An engineered Bacillus subtilis spore expressing the SARS-CoV-2 spike protein receptor binding domain on the spore surface was developed and showed significant increases in neutralizing antibody after oral administration, with no adverse health events observed. These findings provide a basis for further clinical development of Bacillus subtilis spores as an oral vaccine candidate against COVID-19 in the future.
Various types of vaccines, such as mRNA, adenovirus, and inactivated virus by injection, have been developed to prevent SARS-CoV-2 infection. Although some of them have already been approved under the COVID-19 pandemic, various drawbacks, including severe side effects and the requirement for sub-zero temperature storage, may hinder their applications. Bacillus subtilis (B. subtilis) is generally recognized as a safe and endotoxin-free Gram-positive bacterium that has been extensively employed as a host for the expression of recombinant proteins. Its dormant spores are extraordinarily resistant to the harsh environment in the gastrointestinal tract. This feature makes it an ideal carrier for oral administration in resisting this acidic environment and for release in the intestine. In this study, an engineered B. subtilis spore expressing the SARS-CoV-2 spike protein receptor binding domain (sRBD) on the spore surface was developed. In a pilot test, no adverse health event was observed in either mice or healthy human volunteers after three oral courses of B. subtilis spores. Significant increases in neutralizing antibody against sRBD, in both mice and human volunteers, after oral administration were also found. These findings may enable the further clinical developments of B. subtilis spores as an oral vaccine candidate against COVID-19 in the future.
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