Safety, immunogenicity, and optimal dosing of VLPCOV-02, a SARS-CoV-2 saRNA vaccine with modified 5-methylcytosine base
Masayuki Aboshi, Daisuke Kawakami, Kaoru Kono, Ayae Nishiyama, Takuto Nogimori, Yuko Sunada, Kenta Matsuda, Takashi Sekida, Shigeru Suga, Jonathan F. Smith, Nobuaki Sato, Takuya Yamamoto, Wataru Akahata
TL;DR
This study evaluates a modified SARS-CoV-2 RNA vaccine, finding it safe and effective at inducing strong immune responses.
Contribution
The study demonstrates that incorporating 5-methylcytosine improves vaccine safety without reducing immunogenicity.
Findings
VLPCOV-02 induced strong neutralizing antibodies lasting up to 52 weeks.
A 3 μg dose of VLPCOV-02 provided immunity comparable to a 30 μg dose of Comirnaty.
The vaccine induced robust CD4+ and CD8+ T cell responses in both young and elderly participants.
Abstract
Variant-adapted vaccines are becoming increasingly important for continued COVID-19 prevention. Part 1 of the phase 1/2 study with VLPCOV-02, a lipid nanoparticle-encapsulated, self-amplifying RNA (saRNA) vaccine with a modified 5-methylcytosine (5 mC) base, demonstrated lower reactogenicity and incidence of adverse events, and induction of antibody responses. We report results of part 2 with an expanded number of participants (N = 323 [3 μg VLPCOV-02: 53 non-elderly and 54 elderly; 7.5 μg VLPCOV-02: 55 non-elderly and 55 elderly; 30 μg Comirnaty ready to use: 52 non-elderly and 54 elderly]) to determine the optimal dose level. VLPCOV-02 induced robust immunoglobulin G titers against receptor-binding domain and neutralizing antibody titers against all variants of SARS-CoV-2 tested, and induced CD4+ and CD8+ T cell responses. These results indicate that the incorporation of a modified 5…
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Taxonomy
TopicsSARS-CoV-2 and COVID-19 Research · Immune responses and vaccinations · Immunotherapy and Immune Responses