Daichirona (DS-5670) / Daiichi Sankyo, U Tokyo - LARVOL DELTA

Booster vaccination using bivalent DS-5670a/b is safe and immunogenic against SARS-CoV-2 variants in children aged 5-11 years: a phase 2/3, randomized, active-controlled study. (PubMed, Front Immunol) - "Bivalent DS-5670a/b was non-inferior to bivalent BNT162b2 in terms of immunogenicity, and had a manageable safety profile, when administered as a heterologous booster in children aged 5-11 years. https://jrct.niph.go.jp/, identifier jRCT2031220665."

Clinical • Journal • New P1 trial • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

DS-5670a, a novel mRNA-encapsulated lipid nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2: Results from a phase 2 clinical study. (PubMed, Vaccine) - "The novel mRNA-based vaccine candidate DS-5670a provided favorable immune responses against SARS-CoV-2 with a clinically acceptable safety profile. Confirmatory trials are currently ongoing to evaluate the safety and immunogenicity of DS-5670a as the primary vaccine and to assess the immunogenicity when administered as a heterologous or homologous booster."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects (clinicaltrials.gov) - P1/2 | N=142 | Completed | Sponsor: Daiichi Sankyo Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jul 2022

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • MAFB

Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects (clinicaltrials.gov) - P1/2; N=152; Active, not recruiting; Sponsor: Daiichi Sankyo Co., Ltd.; Trial primary completion date: Jul 2022 ➔ Aug 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • MAFB

Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects (clinicaltrials.gov) - P1/2; N=152; Active, not recruiting; Sponsor: Daiichi Sankyo Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • MAFB

Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects (clinicaltrials.gov) - P1/2; N=152; Recruiting; Sponsor: Daiichi Sankyo Co., Ltd.

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • MAFB

Daiichi Sankyo Initiates Phase 1/2 Clinical Trial for mRNA COVID19 vaccine in Japan (Daiichi Sankyo Press Release) - "Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) announced today it has started the first vaccinations in a phase 1/2 clinical trial in Japan of an mRNA vaccine (hereinafter, DS-5670) that is being developed by the company against the novel coronavirus infectious disease...The phase 1/2 trial is being conducted in Japan in a total of 152 healthy adults, including elderly individuals, to evaluate the safety and immunogenicity..."

Trial status • Infectious Disease • Novel Coronavirus Disease