S-268019

S-268019
Vaccine description
Target	SARS-CoV-2
Vaccine type	Protein subunit
Clinical data
Routes of; administration	Intramuscular

S-268019-b is a protein subunit COVID-19 vaccine candidate developed by Shionogi.[1][2]

A study in non-human primates published in 2022 concluded S-268109-b demonstrated efficacy in a SARS-CoV-2 challenge experiment, although neutralizing antibodies against the Omicron variant were reduced.[3]

In a phase 1/2 clinical trial in Japan, the developers concluded reactions to the vaccine were mild, and neutralizing antibodies were similar to those in people who had recovered from Covid-19.[4] A phase 3 trial planned for 54,915 participants began in December 2021 in Vietnam.[5]

Preliminary results of a phase 2/3 trial using S-268019-b as a booster dose after two doses of the BNT162b2 vaccine by Pfizer concluded the vaccine was non-inferior to a booster dose of BNT162b2.[6]

References

"Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults". jrct.niph.go.jp. Japan Registry of Clinical Trials. Retrieved 21 March 2021.
"A Phase 2/3 Study of S-268019". jrct.niph.go.jp. Japan Registry of Clinical Trials. Retrieved 20 October 2021.
Hashimoto M, Nagata N, Homma T, Maeda H, Dohi K, Seki NM, et al. (July 2022). "Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys". Vaccine. 40 (31): 4231–4241. doi:10.1016/j.vaccine.2022.05.081. PMC 9167832. PMID 35691872.
Iwata S, Sonoyama T, Kamitani A, Shibata R, Homma T, Omoto S, et al. (June 2022). "Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings". Vaccine. 40 (27): 3721–3726. doi:10.1016/j.vaccine.2022.04.054. PMC 9122779. PMID 35606235.
"A Phase 3, Randomized, Observer-Blind, Placebo- Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19". ClinicalTrials.gov. National Institutes of Health. 26 July 2022. Retrieved 19 September 2022.
Shinkai M, Sonoyama T, Kamitani A, Shibata RY, Seki NM, Omoto S, et al. (July 2022). "Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study". Vaccine. 40 (32): 4328–4333. doi:10.1016/j.vaccine.2022.06.032. PMC 9212435. PMID 35738968.

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[1] "Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults". jrct.niph.go.jp. Japan Registry of Clinical Trials. Retrieved 21 March 2021.

[2] "A Phase 2/3 Study of S-268019". jrct.niph.go.jp. Japan Registry of Clinical Trials. Retrieved 20 October 2021.

[Preclinical_study_in_monkeys-3] Hashimoto M, Nagata N, Homma T, Maeda H, Dohi K, Seki NM, et al. (July 2022). "Immunogenicity and protective efficacy of SARS-CoV-2 recombinant S-protein vaccine S-268019-b in cynomolgus monkeys". Vaccine. 40 (31): 4231–4241. doi:10.1016/j.vaccine.2022.05.081. PMC 9167832. PMID 35691872.

[Phase_1/2_trial-4] Iwata S, Sonoyama T, Kamitani A, Shibata R, Homma T, Omoto S, et al. (June 2022). "Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings". Vaccine. 40 (27): 3721–3726. doi:10.1016/j.vaccine.2022.04.054. PMC 9122779. PMID 35606235.

[Trial_registration_Vietnam_phase_3_trial-5] "A Phase 3, Randomized, Observer-Blind, Placebo- Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19". ClinicalTrials.gov. National Institutes of Health. 26 July 2022. Retrieved 19 September 2022.

[Booster_after_Pfizer_vax-6] Shinkai M, Sonoyama T, Kamitani A, Shibata RY, Seki NM, Omoto S, et al. (July 2022). "Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study". Vaccine. 40 (32): 4328–4333. doi:10.1016/j.vaccine.2022.06.032. PMC 9212435. PMID 35738968.