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DS-5670a, a novel mRNA-encapsulated lipid nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2: Results from a phase 2 clinical study

Toyama, Kaoru, Eto, Takashi, Takazawa, Kenji, Shimizu, Shinji, Nakayama, Tetsuo, Furihata, Kei, Sogawa, Yoshitaka, Kumazaki, Masafumi, Jonai, Nao, Matsunaga, Satoko, Takeshita, Fumihiko, Yoshihara, Kazutaka, Ishizuka, Hitoshi·2023·Vaccine
DOI 10.1016/j.vaccine.2023.07.012
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Abstract

Background DS-5670a is a vaccine candidate for coronavirus disease 2019 (COVID-19) harnessing a novel modality composed of messenger ribonucleic acid (mRNA) encoding the receptor-binding domain (RBD) from the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) encapsulated in lipid nanoparticles. Here, we report the safety, immunogenicity, and pharmacokinetic profile of DS-5670a from a phase 2 clinical trial in healthy adults who were immunologically naïve to SARS-CoV-2. Methods The study consisted of an open-label, uncontrolled, dose-escalation part and a double-blind, randomized, uncontrolled, 2-arm, parallel-group part. A total of 80 Japanese participants were assigned to receive intramuscular DS-5670a, containing either 30 or 60 µg of mRNA, as two injections administered 4 weeks apart. Safety was assessed by characterization of treatment-emergent adverse events (TEAEs). Immunogenicity was assessed by neutralization titers against SARS-CoV-2, anti-RBD immunoglobulin (Ig)G levels, and SARS-CoV-2 spike-specific T cell responses. Plasma pharmacokinetic parameters of DS-5670a were also evaluated. Results Most solicited TEAEs were mild or moderate with both the 30 and 60 µg mRNA doses. Four participants (10 %) in the 60 µg mRNA group developed severe redness at the injection site, but all cases resolved without treatment. There were no serious TEAEs and no TEAEs leading to discontinuation. Humoral immune responses in both dose groups were greater than…

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Metadata

Authors
Toyama, K., Eto, T., Takazawa, K., Shimizu, S., Nakayama, T., Furihata, K., Sogawa, Y., Kumazaki, M., Jonai, N., Matsunaga, S., Takeshita, F., Yoshihara, K., & Ishizuka, H.
ORCID
Venue
Vaccine
Publisher
Elsevier BV
Published
2023-08
Volume
41
Issue
38
Pages
5525-5534
ISSN
0264-410X
DOI
10.1016/j.vaccine.2023.07.012
Cited by
18
References
3
Language
en
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