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Controlled Clinical Trial
. 2023 Dec 31;19(1):2193074.
doi: 10.1080/21645515.2023.2193074. Epub 2023 Apr 13.

Immunogenicity and safety of single booster dose of KD-414 inactivated COVID-19 vaccine in adults: An open-label, single-center, non-randomized, controlled study in Japan

Junko Terada-Hirashima  1   2 , Yuki Takamatsu  3 , Yosuke Shimizu  4 , Yukari Uemura  4 , Junko S Takeuchi  5 , Noriko Tomita  1 , Kouki Matsuda  3 , Kenji Maeda  3 , Shohei Yamamoto  6 , Ami Fukunaga  6 , Norio Ohmagari  7 , Ayako Mikami  1 , Kengo Sonoda  8 , Mugen Ujiie  7 , Hiroaki Mitsuya  3 , Wataru Sugiura  9
Affiliations
Controlled Clinical Trial

Immunogenicity and safety of single booster dose of KD-414 inactivated COVID-19 vaccine in adults: An open-label, single-center, non-randomized, controlled study in Japan

Junko Terada-Hirashima et al. Hum Vaccin Immunother. .

Abstract

Although vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 (COVID-19) induce effective immune responses, vaccination with booster doses is necessary because of waning immunity. We conducted an open-label, non-randomized, single-arm study in adults in Japan to assess the immunogenicity and safety of a single booster dose of the KD-414 purified whole-SARS-CoV-2-virion inactivated vaccine candidate after vaccination with a primary series of BNT162b2. The primary endpoint was serum neutralizing activity at 7 days after booster injection compared with the primary series of BNT162b2. The SARS-CoV-2-structural protein-binding antibody level and T cell response against SARS-CoV-2-Spike (S) peptides were also examined as secondary endpoints, and safety profile assessments were conducted. Twenty subjects who participated in a previous study declined an injection of KD-414 (non-KD-414 group) and received a booster dose of BNT162b2 instead. The non-KD-414 group was compared to the KD-414 group as a secondary outcome. A single dose of KD-414 induced lower serum neutralizing activity against the wild-type virus within 7 days compared to after the primary series of BNT162b2 but significantly induced anti-SARS-CoV-2-S1-receptor-binding domain-binding immunoglobulin G (IgG) antibodies and SARS-CoV-2-S peptide-specific CD4+ and CD8+ T cell responses. Local or systemic symptoms were significantly lower in the participants who received KD-414 than in those who received BNT162b2 as the third COVID-19 vaccine dose. The present data indicate that a single booster dose of KD-414 induces a substantial immune response in BNT162b2-primed individuals and has a good safety profile, thereby supporting further clinical trials to identify rational targets.

Keywords: COVID-19; COVID-19 vaccine; KD-414; SARS-CoV-2; adverse events; inactivated vaccine; neutralizing antibody; side effects; vaccine safety.

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Conflict of interest statement

Kengo Sonoda is an employee of KM Biologics Co., Ltd. All rights, titles, and interests to the patent of KD-414 have been assigned to KM Biologics Co., Ltd., Kumamoto, Japan. Mugen Ujiie received research funding from KM Biologics, Co., Ltd. for this and one other study. All other authors declare that they have no competing interests related to this study.

Figures

Figure 1.
Figure 1.
Study protocol(a) and flow diagram(b).
Figure 2.
Figure 2.
Kinetics of serum SARS-CoV-2-neutralizing activity.
Figure 3.
Figure 3.
CD4+ and/or CD8+ T cell responses after vaccination.
See this image and copyright information in PMC

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