Evidence map›Paper›PMID 40404620›Full record

ArticleNPJ vaccines2025

Live attenuated SARS-CoV-2 vaccine OTS-228 demonstrates efficacy, safety, and stability in preclinical model.

Tobias Britzke, Nico Joël Halwe, Lorenz Ulrich, Angele Breithaupt, G Tuba Barut, Claudia Wylezich, Nadine Ebert, Bettina Salome Trüeb, Volker Thiel, Donata Hoffmann and 2 more

Abstract read
In one paragraph

Article in NPJ vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

12 authors.

Tobias BritzkeDepartment of Experimental Animal Facilities and Biorisk Management, Friedrich-Loeffler-Institut, Greifswald, Germany.
Nico Joël HalweInstitute of Diagnostic Virology, Friedrich-Loeffler-Institut, Greifswald, Germany.
Lorenz UlrichInstitute of Diagnostic Virology, Friedrich-Loeffler-Institut, Greifswald, Germany.
Angele BreithauptDepartment of Experimental Animal Facilities and Biorisk Management, Friedrich-Loeffler-Institut, Greifswald, Germany.
G Tuba BarutInstitute of Virology and Immunology, Vetsuisse Faculty, University of Bern, Bern and Mittelhäusern, Switzerland.
Claudia WylezichDepartment of Experimental Animal Facilities and Biorisk Management, Friedrich-Loeffler-Institut, Greifswald, Germany.
Nadine EbertInstitute of Virology and Immunology, Vetsuisse Faculty, University of Bern, Bern and Mittelhäusern, Switzerland.
Bettina Salome TrüebInstitute of Virology and Immunology, Vetsuisse Faculty, University of Bern, Bern and Mittelhäusern, Switzerland.
Volker ThielInstitute of Virology and Immunology, Vetsuisse Faculty, University of Bern, Bern and Mittelhäusern, Switzerland.
Donata HoffmannInstitute of Diagnostic Virology, Friedrich-Loeffler-Institut, Greifswald, Germany. donata.hoffmann@fli.de.
Martin BeerInstitute of Diagnostic Virology, Friedrich-Loeffler-Institut, Greifswald, Germany. martin.beer@fli.de.
Jacob SchönInstitute of Diagnostic Virology, Friedrich-Loeffler-Institut, Greifswald, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Live attenuated vaccines (LAV) have the potential to meet all the criteria for an efficacious vaccine. In addition to providing protection against the target disease, they offer the potential to prevent transmission, provide cross-protection by stimulating humoral and cellular immunity, and allow versatility in application routes. The SARS-CoV-2 LAV candidate, OTS-228, has demonstrated excellent safety and high efficacy in preclinical models, inducing transmission-blocking immunity and providing full protection, even against variants such as Omicron BA.2, BA.5, and XBB.1.5. However, to ensure that OTS-228 has no dose-dependent side effects and to evaluate potential risk of reversion to virulence-a known general issue with live vaccines-detailed characterization of LAV OTS-228 is essential. To address this, we conducted four different experiments using Syrian hamsters, a model for moderate to severe COVID-19. A maximum dose trial confirmed the vaccine's full attenuation and prevention of transmission, even at high doses. In addition, four intentional serial in vivo passages demonstrated the genomic stability of the vaccine and the non-infectivity of nasal washings. Furthermore, OTS-228 maintained its attenuation and immunogenicity even after 15 additional in vitro passages, providing full protection against lung infection with virulent SARS-CoV-2 strains. Finally, a low-dose experiment confirmed the high efficacy of the vaccine candidate, establishing the protective dose 50 (PD

Identifiers

PMID40404620
PMCPMC12098885

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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.