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

• Published in: Human vaccines & immunotherapeutics Vol. 19; no. 1; p. 2193074
• Main Authors: Terada-Hirashima, Junko, Takamatsu, Yuki, Shimizu, Yosuke, Uemura, Yukari, Takeuchi, Junko S., Tomita, Noriko, Matsuda, Kouki, Maeda, Kenji, Yamamoto, Shohei, Fukunaga, Ami, Ohmagari, Norio, Mikami, Ayako, Sonoda, Kengo, Ujiie, Mugen, Mitsuya, Hiroaki, Sugiura, Wataru
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 31.12.2023; Taylor & Francis Group
• Subjects: Adult; adverse events; Antibodies, Neutralizing; Antibodies, Viral; BNT162 Vaccine; Coronavirus; COVID-19; COVID-19 - prevention & control; COVID-19 vaccine; COVID-19 Vaccines - adverse effects; Humans; Immunogenicity, Vaccine; inactivated vaccine; Japan; KD-414; neutralizing antibody; SARS-CoV-2; side effects; vaccine safety; Japan; COVID-19; vaccine safety; SARS-CoV-2; inactivated vaccine; COVID-19 vaccine; neutralizing antibody; side effects; adverse events; KD-414
• ISSN: 2164-5515; 2164-554X
• DOI: 10.1080/21645515.2023.2193074

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.