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
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
Affiliations
Hironori Nakagami
Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Hiroki Hayashi
Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Jiao Sun
Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Yuka Yanagida
Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Takako Otera
Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Futoshi Nakagami
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Shigeto Hamaguchi
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Hisao Yoshida
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Hideo Okuno
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Shota Yoshida
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Ryo Nakamaru
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Serina Yokoyama
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Taku Fujimoto
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Kazuhiro Hongyo
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Yukihiro Akeda
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Ryuichi Morishita
Department of Clinical Gene Therapy, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Kazunori Tomono
Division of Infection Control and Prevention, Osaka University Hospital, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
Hiromi Rakugi
Department of Geriatric and General Medicine, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
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.
