We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





Moderna Completes Enrollment for Phase 2 Study of mRNA COVID-19 Vaccine

By HospiMedica International staff writers
Posted on 09 Jul 2020
Print article
Illustration
Illustration
Moderna, Inc. (Cambridge, MA, USA) has completed enrollment for both cohorts of the Phase 2 study of its vaccine candidate (mRNA-1273) against COVID-19.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by the company for development. mRNA-1273 is Moderna’s second mRNA vaccine for an infectious disease to complete enrollment of a Phase 2 study, following the company’s CMV Phase 2 study, which was fully enrolled on March 3, 2020. The Phase 2 placebo-controlled, dose-confirmation study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each participant is receiving placebo, a 50 μg or a 100 μg dose at both vaccinations.

On June 11, 13 days after the first participant was dosed, the company announced that the cohort of healthy younger adults ages 18-55 (n=300) and the sentinel group of older adults ages 55 years and above (n=50) in the Phase 2 study of mRNA-1273 was complete. After reviewing the safety data from the sentinel cohort of older adults, on June 25, the Data and Safety Monitoring Committee of the study recommended Moderna to proceed with enrollment for the remainder of the Phase 2 study. The cohort of older adults (n=300) has now been fully enrolled. The company also announced that the cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 study have completed enrollment.

Additionally, Moderna has finalized the Phase 3 study protocol based on feedback from the US Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the US and is expected to be conducted in collaboration with NIAID, subject to regulatory approval. Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose at 100 μg, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to one billion doses per year, beginning in 2021.

“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,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “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.”

Related Links:
Moderna, Inc.

Gold Member
12-Channel ECG
CM1200B
Gold Member
Real-Time Diagnostics Onscreen Viewer
GEMweb Live
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Silver Member
ECG Management System
NEMS-Q

Print article

Channels

Critical Care

view channel
Image: Researchers have developed an advanced shear-thinning hydrogel for aneurysm repair (Photo courtesy of TIBI)

New Hydrogel Features Enhanced Capabilities for Treating Aneurysms and Halting Progression

Aneurysms can develop in blood vessels in different body areas, often as a result of atherosclerosis, infections, inflammatory diseases, and other risk factors. These conditions lead to chronic inflammation,... Read more

Surgical Techniques

view channel
Image: The living replacement knee will be tested in clinical trials within five years (Photo courtesy of ARPA-H)

Living Knee Replacement to Revolutionize Osteoarthritis Treatment

Osteoarthritis is the most prevalent type of arthritis, characterized by the progressive deterioration of cartilage, or the protective tissue covering the bone ends, resulting in pain, stiffness, and impaired... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.