tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2023 Apr 13;2193074.
doi: 10.1080/21645515.2023.2193074. Online ahead of print.
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[SUP] 1 2 [/SUP], Yuki Takamatsu[SUP] 3 [/SUP], Yosuke Shimizu[SUP] 4 [/SUP], Yukari Uemura[SUP] 4 [/SUP], Junko S Takeuchi[SUP] 5 [/SUP], Noriko Tomita[SUP] 1 [/SUP], Kouki Matsuda[SUP] 3 [/SUP], Kenji Maeda[SUP] 3 [/SUP], Shohei Yamamoto[SUP] 6 [/SUP], Ami Fukunaga[SUP] 6 [/SUP], Norio Ohmagari[SUP] 7 [/SUP], Ayako Mikami[SUP] 1 [/SUP], Kengo Sonoda[SUP] 8 [/SUP], Mugen Ujiie[SUP] 7 [/SUP], Hiroaki Mitsuya[SUP] 3 [/SUP], Wataru Sugiura[SUP] 9 [/SUP]
Affiliations
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[SUP]+[/SUP] and CD8[SUP]+[/SUP] 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.
. 2023 Apr 13;2193074.
doi: 10.1080/21645515.2023.2193074. Online ahead of print.
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[SUP] 1 2 [/SUP], Yuki Takamatsu[SUP] 3 [/SUP], Yosuke Shimizu[SUP] 4 [/SUP], Yukari Uemura[SUP] 4 [/SUP], Junko S Takeuchi[SUP] 5 [/SUP], Noriko Tomita[SUP] 1 [/SUP], Kouki Matsuda[SUP] 3 [/SUP], Kenji Maeda[SUP] 3 [/SUP], Shohei Yamamoto[SUP] 6 [/SUP], Ami Fukunaga[SUP] 6 [/SUP], Norio Ohmagari[SUP] 7 [/SUP], Ayako Mikami[SUP] 1 [/SUP], Kengo Sonoda[SUP] 8 [/SUP], Mugen Ujiie[SUP] 7 [/SUP], Hiroaki Mitsuya[SUP] 3 [/SUP], Wataru Sugiura[SUP] 9 [/SUP]
Affiliations
- PMID: 37052247
- DOI: 10.1080/21645515.2023.2193074
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[SUP]+[/SUP] and CD8[SUP]+[/SUP] 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.