S-268019

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

Last updated December 31, 2023

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]

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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.

Scholia has a profile for S-268019 (Q110269731).

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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.

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