tetano
Editor, Senior Moderator
Cell Rep Med
. 2023 Aug 15;4(8):101134.
doi: 10.1016/j.xcrm.2023.101134. Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study
Wataru Akahata[SUP] 1 [/SUP], Takashi Sekida[SUP] 2 [/SUP], Takuto Nogimori[SUP] 3 [/SUP], Hirotaka Ode[SUP] 4 [/SUP], Tomokazu Tamura[SUP] 5 [/SUP], Kaoru Kono[SUP] 2 [/SUP], Yoko Kazami[SUP] 2 [/SUP], Ayaka Washizaki[SUP] 3 [/SUP], Yuji Masuta[SUP] 3 [/SUP], Rigel Suzuki[SUP] 5 [/SUP], Kenta Matsuda[SUP] 6 [/SUP], Mai Komori[SUP] 6 [/SUP], Amber L Morey[SUP] 6 [/SUP], Keiko Ishimoto[SUP] 6 [/SUP], Misako Nakata[SUP] 2 [/SUP], Tomoko Hasunuma[SUP] 7 [/SUP], Takasuke Fukuhara[SUP] 8 [/SUP], Yasumasa Iwatani[SUP] 9 [/SUP], Takuya Yamamoto[SUP] 3 [/SUP], Jonathan F Smith[SUP] 6 [/SUP], Nobuaki Sato[SUP] 2 [/SUP]
Affiliations
VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164). Participants who completed two doses of the BNT162b2 mRNA vaccine previously are randomized to receive one intramuscular vaccination of 0.3, 1.0, or 3.0 μg VLPCOV-01, 30 μg BNT162b2, or placebo. No serious adverse events have been reported. VLPCOV-01 induces robust immunoglobulin G (IgG) titers against the RBD protein that are maintained up to 26 weeks in non-elderly participants, with geometric means ranging from 5,037 (95% confidence interval [CI] 1,272-19,940) at 0.3 μg to 12,873 (95% CI 937-17,686) at 3 μg compared with 3,166 (95% CI 1,619-6,191) with 30 μg BNT162b2. Neutralizing antibody titers against all variants of SARS-CoV-2 tested are induced. VLPCOV-01 is immunogenic following low-dose administration. These findings support the potential for saRNA as a vaccine platform.
Keywords: COVID-19; RBD antigen; SARS-CoV-2; booster vaccine; immunogenicity; safety; self-amplifying RNA.
. 2023 Aug 15;4(8):101134.
doi: 10.1016/j.xcrm.2023.101134. Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study
Wataru Akahata[SUP] 1 [/SUP], Takashi Sekida[SUP] 2 [/SUP], Takuto Nogimori[SUP] 3 [/SUP], Hirotaka Ode[SUP] 4 [/SUP], Tomokazu Tamura[SUP] 5 [/SUP], Kaoru Kono[SUP] 2 [/SUP], Yoko Kazami[SUP] 2 [/SUP], Ayaka Washizaki[SUP] 3 [/SUP], Yuji Masuta[SUP] 3 [/SUP], Rigel Suzuki[SUP] 5 [/SUP], Kenta Matsuda[SUP] 6 [/SUP], Mai Komori[SUP] 6 [/SUP], Amber L Morey[SUP] 6 [/SUP], Keiko Ishimoto[SUP] 6 [/SUP], Misako Nakata[SUP] 2 [/SUP], Tomoko Hasunuma[SUP] 7 [/SUP], Takasuke Fukuhara[SUP] 8 [/SUP], Yasumasa Iwatani[SUP] 9 [/SUP], Takuya Yamamoto[SUP] 3 [/SUP], Jonathan F Smith[SUP] 6 [/SUP], Nobuaki Sato[SUP] 2 [/SUP]
Affiliations
- PMID: 37586325
- DOI: 10.1016/j.xcrm.2023.101134
VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164). Participants who completed two doses of the BNT162b2 mRNA vaccine previously are randomized to receive one intramuscular vaccination of 0.3, 1.0, or 3.0 μg VLPCOV-01, 30 μg BNT162b2, or placebo. No serious adverse events have been reported. VLPCOV-01 induces robust immunoglobulin G (IgG) titers against the RBD protein that are maintained up to 26 weeks in non-elderly participants, with geometric means ranging from 5,037 (95% confidence interval [CI] 1,272-19,940) at 0.3 μg to 12,873 (95% CI 937-17,686) at 3 μg compared with 3,166 (95% CI 1,619-6,191) with 30 μg BNT162b2. Neutralizing antibody titers against all variants of SARS-CoV-2 tested are induced. VLPCOV-01 is immunogenic following low-dose administration. These findings support the potential for saRNA as a vaccine platform.
Keywords: COVID-19; RBD antigen; SARS-CoV-2; booster vaccine; immunogenicity; safety; self-amplifying RNA.