Evidence map›Paper›PMID 38352232›Full record

ArticleiScience2024

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

Masayuki Aboshi, Kenta Matsuda, Daisuke Kawakami, Kaoru Kono, Yoko Kazami, Takashi Sekida, Mai Komori, Amber L Morey, Shigeru Suga, Jonathan F Smith and 5 more

Open access · goldAbstract read
In one paragraph

Article in iScience, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
11.3field-weighted citation impact, top 1% of its field
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

26 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Renaissance of antiviral CD8Nature reviews. Immunology · 2026
    Review
  5. Review
  6. Article
  7. Article
  8. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. The advent of clinical self-amplifying RNA vaccines.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

15 authors at 5 institutions in 2 countries.

Masayuki AboshiVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Kenta MatsudaVLP Therapeutics, Inc., Gaithersburg, MD 20878, USA.
Daisuke KawakamiVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Kaoru KonoVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Yoko KazamiVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Takashi SekidaVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Mai KomoriVLP Therapeutics, Inc., Gaithersburg, MD 20878, USA.
Amber L MoreyVLP Therapeutics, Inc., Gaithersburg, MD 20878, USA.
Shigeru SugaNational Hospital Organization, Mie National Hospital, Tsu, Mie 514-0125, Japan.
Jonathan F SmithVLP Therapeutics, Inc., Gaithersburg, MD 20878, USA.
Takasuke FukuharaDepartment of Microbiology and Immunology, Faculty of Medicine, Hokkaido University, Sapporo, Hokkaido 060-0815, Japan.
Yasumasa IwataniClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan.
Takuya YamamotoLaboratory of Precision Immunology, Center for Intractable Diseases and ImmunoGenomics, National Institutes of Biomedical Innovation, Health and Nutrition, Ibaraki, Osaka 567-0085, Japan.
Nobuaki SatoVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
Wataru AkahataVLP Therapeutics Japan, Inc., 1-16-4 Nishi-Shinbashi, Minato-ku, Tokyo 105-0003, Japan.
VLP Therapeutics (United States) · USHokkaido University · JPNational Hospital Organization · JPNational Institute of Biomedical Innovation, Health and Nutrition · JPNational Mie Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

ImmunologyVirology

Identifiers

PMID38352232
PMCPMC10863314
OpenAlexW4391113138

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.