# Safety and immunogenicity of VLPCOV-02, a SARS-CoV-2 self-amplifying RNA vaccine with a modified base, 5-methylcytosine

Article · Aboshi M, Matsuda K, Kawakami D, Kono K, Kazami Y, Sekida T, Komori M, Morey AL, Suga S, Smith JF, Fukuhara T, Iwatani Y, Yamamoto T, Sato N, Akahata W

- Archive id: doi:10.1016/j.isci.2024.108964
- Published: 2024-01-22
- Venue: iScience
- DOI: https://doi.org/10.1016/j.isci.2024.108964
- PMID: 38352232
- PMCID: PMC10863314
- Citations: 33
- Source URL: https://doi.org/10.1016/j.isci.2024.108964
- PDF: https://europepmc.org/articles/PMC10863314/pdf
- Provenance: europepmc

## Abstract

Continuing emergence of variants of concern resulting in reduced SARS-CoV-2 vaccine efficacy necessitates additional prevention strategies. The structure of VLPCOV-01, a lipid nanoparticle-encapsulated, self-amplifying RNA COVID-19 vaccine with a comparable immune response to BNT162b2, was revised by incorporating a modified base, 5-methylcytosine, to reduce reactogenicity, and an updated receptor-binding domain derived from the Brazil (gamma) variant. Interim analyses of a phase 1 dose-escalation booster vaccination study with the resulting construct, VLPCOV-02, in healthy, previously vaccinated Japanese individuals (N = 96) are reported (jRCT2051230005). A dose-related increase in solicited local and systemic adverse events was observed, which were generally rated mild or moderate. The most commonly occurring events were tenderness, pain, fatigue, and myalgia. Serum SARS-CoV-2 immunoglobulin titers increased during the 4 weeks post-immunization. VLPCOV-02 demonstrated a favorable safety profile compared with VLPCOV-01, with reduced adverse events and fewer fever events at an equivalent dose. These findings support further study of VLPCOV-02.

_Abstract reproduced under CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)._

Topics: [mRNA Therapeutics & Cancer Vaccines](https://space-kitty.com/topics/mrna-cancer-vaccines)

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