VLP Therapeutics Japan, Inc. (VLPT Japan) researchers and their colleagues at the National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN), the National Hospital Organization Nagoya Medical Center, and Hokkaido University’s School of Medicine in Japan published a paper in iScience online reporting safety and immunogenicity of VLPCOV-02, a SARS-CoV-2 self-amplifying RNA vaccine with a modified base, 5-methylcytosine. This research was supported by AMED under Grant Number JP21nf0101627.

  • Authors: Masayuki Aboshi, Kenta Matsuda, Daisuke Kawakami, Kaoru Kono, Yoko Kazami, Takashi Sekida, Mai Komori, Amber L. Morey, Shigeru Suga, Jonathan F. Smith, Takasuke Fukuhara, Yasumasa Iwatani, Takuya Yamamoto, Nobuaki Sato, and Wataru Akahata* (*Corresponding author)
  • DOI: https://doi.org/10.1016/j.isci.2024.108964
  • URL: https://www.cell.com/iscience/fulltext/S2589-0042(24)00185-8
  • Published: 22 Jan 2024
  • 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.

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About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Maryland, US-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of vaccine treatment. VLPT is currently engaged in research and development of a cancer treatment vaccine as well as prophylactic vaccines against infectious diseases including malaria and dengue.

About VLP Therapeutics Japan: VLP Therapeutics Japan, Inc. (VLPT Japan), founded in 2020 by Dr. Wataru Akahata originally as a wholly owned subsidiary of US-based VLP Therapeutics, Inc., is a Tokyo-based biotech company. VLPT Japan is currently engaged in research and development of prophylactic vaccines against infectious diseases, including COVID-19, influenza, and dengue. The COVID-19 project is funded by the Japan Agency for Medical Research and Development (AMED) and the Japanese Ministry of Health, Labour and Welfare.