Moderna is targeting July 27 to begin phase 3 testing of their COVID-19 vaccine. The company is looking for thousands of volunteers to participate.
The Cambridge, Massachusetts-based biotech company is the first to announce an estimated start date for phase 3 trials in the United States.
Newly released data from earlier human trials showed their vaccine candidate appears to be safe and provide some immunity. The most commonly reported systemic adverse events following second vaccination at the 100 microgram dose were fatigue (80%), chills (80%), headache (60%), and myalgia (53%), all of which were moderate in severity. The most common local adverse event at the 100 microgram dose was pain at the injection site (100%), which was also transient and mild or moderate in severity.
New data from early trials shows Moderna’s COVID-19 vaccine candidate appears to be safe and provide some immunity.
Guidance for Vaccine Volunteers
Information about the trial, including guidance for vaccine volunteers, was posted on clinicaltrials.gov on Tuesday.
A brief summary posted on the site says, “The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.”
Moderna describes mRNA as like software for the cell; mRNA medicines are sets of instructions. And these instructions direct cells in the body to make proteins to prevent or fight disease.
Below is a video Moderna posted to its Facebook page describing the use of mRNA therapeutics.
Moderna Therapeutics is pioneering messenger RNA therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn active intracellularly or secreted. This breakthrough platform addresses currently undruggable targets, and offers a superior alternative to existing drug modalities for a wide range of disease conditions.
Posted by Moderna, Inc. on Thursday, July 3, 2014
For inclusion in the study, volunteers must meet several criteria including the following:
- Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Able to comply with study procedures based on the assessment of the Investigator.
- Female participants of non-childbearing potential may be enrolled in the study.
- Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
- Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
- Has agreed to continue adequate contraception through three months following the second dose on Day 29.
- Is not breastfeeding.
- Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through three months after the second dose.
- Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment.
Moderna tweeted information and a link about the study Tuesday.
The https://t.co/XvCSRI7uD8 listing for Moderna’s Phase 3 study of mRNA-1273, our #vaccine candidate against COVID-19 is now live. Find more information on the study including site locations here: https://t.co/9uIYZ069JU pic.twitter.com/QkPEoAXw7b
— Moderna (@moderna_tx) July 14, 2020
California Study Locations
Several locations throughout California will be utilized and volunteers will be needed for each.
- Advanced Clinical Research, Rancho Paseo in Banning
- University of California San Diego in La Jolla
- eStudySite in La Mesa
- UCLA Vine Street Clinic CRS in Los Angeles
- Paradigm Clinical Research Institute Inc. in Redding
- Benchmark Research in Sacramento
- Medical Center For Clinical Research, M3 Wake Research in San Diego
If you are interested, contact Moderna Clinical Trials at (855) 663-6762 or email firstname.lastname@example.org
The randomized, placebo-controlled trial is expected to include approximately 30,000 participants at the 100 microgram dose level in the U.S.
Early Results Encouraging
Moderna’s experimental vaccine against the coronavirus showed encouraging results in early testing.
COVID-19 antibodies were found in all 45 participants, the biotech company announced in a May news release.
Neal Browning of Bothell, Washington, spoke to GV Wire via Zoom shortly after the early testing results were made public.
“I’m the second person to receive the vaccine in a small dose so that means I’ve got the antibodies,” Browning said. “One of the first people to reach out to me was Jennifer Haller, the lady who was the first to receive the vaccine. She was super excited, too. We chatted a little bit on text about that.”
Moderna said the early vaccine data indicated that it provided full protection against viral replication in the lungs in a mouse challenge model.
An interim analysis just published in The New England Journal of Medicine shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.
In a press release, Moderna says, “After two vaccinations, mRNA-1273 elicited robust neutralizing antibody titers. At Day 43, neutralizing activity against SARS-CoV-2 was seen in all evaluated participants.”
Moderna has posted a video of a conference call on Wednesday providing more information to investors.
500 Million Doses a Year
Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network to conduct the Phase 3 study.
With the Phase 3 dose being finalized at 100 micrograms, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.
In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. On July 9, Moderna announced a collaboration with ROVI for large-scale, commercial fill-finish manufacturing of mRNA-1273 intended in principle to supply markets outside of the U.S. starting in early 2021 at ROVI’s facility in Madrid, Spain.