Therapy Areas: Infectious Diseases
Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Starts
28 July 2020 - - A Phase 3 study of US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants, the company said.

The Phase 3 study, called the COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services.

The Phase 3 study protocol follows the US Food and Drug Administration guidance on clinical trial design for COVID-19 vaccine studies.

The randomised, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg.

The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology.

SARS-CoV-2 is the virus that causes COVID-19.

The primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease.

To ensure the ongoing safety monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organised by NIAID throughout the study.
The clinicaltrials.gov identifier is NCT04470427.

Moderna is working closely with BARDA and the NIH, including NIAID's COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under the auspices of Operation Warp Speed.

Moderna also is collaborating with long-standing partner PPD (NASDAQ: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

PPD supported the Phase 2 study for Moderna's COVID-19 vaccine program, which completed the enrollment of 600 subjects at eight research sites within a month.

PPD has contributed an array of clinical development and laboratory services, including strategic expertise to the study design, patient-enrollment epidemiology modeling and biostatistics.

With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.

The clinical research sites, with the support of the company, are working within their local communities to reach a diverse population.

Working together with collaborators, the company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.

The company remains on track to be able to deliver approximately 500 m doses per year, and possibly up to 1 bn doses per year, beginning in 2021 because of the company's internal US manufacturing capabilities and strategic collaboration with Lonza, Ltd.

In addition, Moderna recently announced a collaboration with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent's biologics facility for the US, and with ROVI of Spain for fill-finish manufacturing outside the US.

A summary of the company's work to date on COVID-19 can be found here.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

On May 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the company's Phase 2 study of mRNA-1273 are fully enrolled.

Moderna also recently announced that data from an interim analysis of the Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine.

Moderna scientists designed the company's prophylactic vaccines modality to prevent infectious diseases.

More than 1,900 participants have been enrolled in Moderna's infectious disease vaccine clinical studies under health authorities in the US, Europe and Australia.

Clinical data demonstrate that Moderna's proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens.

Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production.

Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.

Moderna currently has nine development candidates in its prophylactic vaccines modality. Moderna is advancing messenger RNA science to create a new class of medicines for patients.

mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.
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