Moderna completes enrollment for phase 2 trial of mRNA-1273
Moderna said that it has concluded enrollment for the two cohorts of the phase 2 study of its COVID-19 vaccine candidate mRNA-1273.
According to the US biotech company, mRNA-1273 is its second messenger RNA (mRNA) vaccine for an infectious disease to have wrapped up enrollment of a phase 2 clinical trial, after its CMV Phase 2 study, which was fully enrolled in early March 2020.
Last month, 13 days after dosing the first participant, Moderna had said that the cohort of healthy younger adults ages 18-55 and the sentinel group of older adults aged 55 years and over in the phase 2 clinical trial of mRNA-1273 was complete.
After review of the safety data from the sentinel cohort of older adults, the Data and Safety Monitoring Committee of the study had last month recommended Moderna to move ahead with enrollment for the remainder of the phase 2 coronavirus clinical trial.
The cohort of older adults has now been enrolled completely.
Moderna said that the phase 2 placebo-controlled, dose-confirmation study will assess the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given with a gap of 28 days. Each of the participants is subjected to placebo, a 50 μg or a 100 μg dose at both vaccinations.
The US biotech company also announced that the cohorts of older adults – aged between 56-70, and elderly adults aged 71 and above in NIH-led phase 1 clinical trial have wrapped up enrollment.
Tal Zaks – Chief Medical Officer at Moderna said: “I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the Phase 2 study of mRNA-1273, our vaccine candidate against COVID-19.
“We are committed to helping address this ongoing public health emergency and continue to focus on our Phase 3 study, which remains on track to start in July, less than seven months from the sequencing of the virus.”
Moderna said that it has finalized the phase 3 clinical trial protocol based on feedback from the US Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled coronavirus trial is likely to include nearly 30,000 participants at the 100 µg dose level in the US and is anticipated to be carried out in collaboration with NIAID, subject to regulatory approval.
The US biotech company said that it has completed the manufacturing of vaccine needed for beginning the phase 3 trial.
With the Phase 3 dose at 100 μg, Moderna said that it is on track to deliver around 500 million doses annually, and potentially up to a billion doses per year, starting from 2021 from its internal US manufacturing site and collaboration with Swiss chemicals company Lonza Group.
Additionally, Moderna recently entered into a partnership with US pharma company Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at the latter’s biologics facility in Indiana.