Evidence map›Paper›PMID 41053546›Full record

ArticleBMC microbiology2025

Toxicity study of SARS-CoV-2 Spike protein expressed on Bacillus subtilis spores.

Atiqah Hazan, Amalia A Saperi, Nurfatihah Zulkifli, Nor-Aziyah Mat Rahim, Vunjia Tiong, Hai Yen Lee, Sazaly AbuBakar

Abstract read
In one paragraph

Article in BMC microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Atiqah HazanTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Amalia A SaperiTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Nurfatihah ZulkifliTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Nor-Aziyah Mat RahimVirology Unit, Infectious Diseases Research Centre, Institute for Medical Research, National Institutes of Health, Shah Alam, 40170, Malaysia.
Vunjia TiongTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Hai Yen LeeTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Sazaly AbuBakarTropical Infectious Diseases Research & Education Centre (TIDREC), Universiti Malaya, Kuala Lumpur, 50603, Malaysia. sazaly@um.edu.my.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe SARS-CoV-2 spike protein is the primary antigen used in most COVID-19 vaccines. To improve protection, especially at mucosal surfaces, a robust and safe delivery system capable of inducing both systemic and mucosal immunity is needed. Bacillus subtilis spores offer a promising platform due to their stability, safety, and capacity for protein display. A study to evaluate the potential acute oral toxicity of recombinant B. subtilis spores expressing SARS-CoV-2 spike proteins was undertaken.

resultsB. subtilis spore was used to express the SARS-CoV-2 S1 domain spike proteins during the bacterial sporulation. No in vitro cytotoxicity was observed when the spores were used to treat cells. BALB/c mice were given a single oral dose (5 × 10

conclusionThese findings suggest that the SARS-CoV-2 S1 domain spike proteins expressed on B. subtilis spores is well tolerated in mice when administered orally at a high dose. Findings from this study, hence, support further investigation of the recombinant bacterial spores expressing SARS-CoV-2 S1 domain spike proteins as an oral vaccine candidate against SARS-CoV-2 infection.

Indexed as

Bacillus subtilisCOVID-19 VaccinesSARS-CoV-2Spike Glycoprotein, CoronavirusSpores, BacterialAdministration, OralAnimalsCOVID-19FemaleHumansMiceMice, Inbred BALB CCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Acute toxicityBacillus subtilisSARS-CoV-2Spike proteinVaccine

Identifiers

PMID41053546
PMCPMC12502241

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.