論文

査読有り 国際誌
2022年8月30日

Phase I Study to Assess the Safety and Immunogenicity of an Intradermal COVID-19 DNA Vaccine Administered Using a Pyro-Drive Jet Injector in Healthy Adults.

Vaccines
  • Hironori Nakagami
  • Hiroki Hayashi
  • Jiao Sun
  • Yuka Yanagida
  • Takako Otera
  • Futoshi Nakagami
  • Shigeto Hamaguchi
  • Hisao Yoshida
  • Hideo Okuno
  • Shota Yoshida
  • Ryo Nakamaru
  • Serina Yokoyama
  • Taku Fujimoto
  • Kazuhiro Hongyo
  • Yukihiro Akeda
  • Ryuichi Morishita
  • Kazunori Tomono
  • Hiromi Rakugi
  • 全て表示

10
9
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.3390/vaccines10091427

We conducted a nonrandomized, open-label phase I study to assess the safety and immunogenicity of an intradermal coronavirus disease 2019 (COVID-19) DNA vaccine (AG0302-COVID-19) administered using a pyro-drive jet injector at Osaka University Hospital between Yanagida November 2020 and December 2021. Twenty healthy volunteers, male or female, were enrolled in the low-dose (0.2 mg) or high-dose (0.4 mg) groups and administered AG0302-COVID19 twice at a 2-week interval. There were no adverse events that led to discontinuation of the study drug vaccination schedule. A serious adverse event (disc protrusion) was reported in one patient in the high-dose group, but the individual recovered, and the adverse event was not causally related to the study drug. In the analysis of the humoral immune response, the geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike glycoprotein-specific antibody was low in both the low-dose and high-dose groups (246.2 (95% CI 176.2 to 344.1, 348.2 (95% CI 181.3 to 668.9)) at the 8 weeks after first vaccination. Regarding the analysis of the cellular immune, the number of IFN-γ-producing cells responsive to the SARS-CoV-2 spike glycoprotein increased with individual differences after the first dose and was sustained for several months. Overall, no notable safety issues were observed with the intradermal inoculations of AG0302-COVID19. Regarding immunogenicity, a cellular immune response was observed in some subjects after AG0302-COVID19 intradermal inoculation, but no significant antibody production was observed.

リンク情報
DOI
https://doi.org/10.3390/vaccines10091427
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/36146505
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9503587
ID情報
  • DOI : 10.3390/vaccines10091427
  • PubMed ID : 36146505
  • PubMed Central 記事ID : PMC9503587

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