Moderna has dosed the first participant in the Phase I/II study of its Covid-19 vaccine candidate, (mRNA-1273 or TAK-919), in Japan, led by Takeda Pharmaceutical.
TAK-919 is Takeda’s development code for Moderna’s vaccine candidate for Covid-19.
Moderna CEO Stéphane Bancel said: “We are pleased that this Phase I/II study of our Covid-19 vaccine in healthy adults in Japan has begun.
“This is the first clinical trial of a Moderna product in Japan and we thank Takeda for partnering with us to potentially protect the Japanese population from Covid-19 with a vaccine.”
The multi-centre, placebo-controlled Phase I/II study will analyse the safety and immunogenicity of two intramuscular (IM) doses of mRNA-1273 in healthy Japanese male and female adults, administered 28 days apart.
Takeda plans to enrol 200 subjects aged 20 years and above in the country. Each subject will be randomly assigned to receive either placebo or a 100μg dose each of the vaccine at both inoculations.
They will be followed up for a year after the second vaccination.
The trial’s primary outcomes include the percentage of subjects with reported solicited local adverse events (AEs) for seven days after each dose and percentage of subjects with Covid-19 until day 57 among others.
Last October, the Ministry of Health, Labour and Welfare of Japan (MHLW) agreed to purchase and distribute 50 million doses of Moderna’s mRNA-1273 starting in the first half of this year, subject to regulatory approvals.
Moderna will produce and supply the vaccine while Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED), and Moderna, which is in charge of all import, local regulatory, development and distribution activities in Japan.
Last month, Moderna initiated dosing in a Phase II/III study of its Covid-19 vaccine candidate, mRNA-1273, in healthy adolescent participants aged between 12 and 17.