mRNA Vaccine for COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new mRNA COVID-19 vaccine against both known and emerging variants of the virus. Participants will receive a shot of the mRNA-1273 Variant-containing Formulation to assess their immune response. Individuals who have already been vaccinated and may be at risk for severe COVID-19 could be suitable candidates. Interested participants should not have had a recent COVID-19 infection or received a vaccine shot too close to the trial's start. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective vaccine benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or immune-modifying drugs, you may not be eligible to participate.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or immune-modifying drugs, you may not be eligible to participate.
What is the safety track record for the mRNA-1273 variant-containing formulation?
Previous studies have shown that the mRNA-1273 vaccine, also known as Spikevax, is safe for people. Research indicates that this vaccine is generally well-tolerated, with most experiencing only mild side effects, such as sore arms or slight fevers, which resolve on their own. Serious side effects are rare. The vaccine's widespread use has generated extensive safety data, providing reassurance.
It is important to note that the mRNA-1273 vaccine is already approved for use in other COVID-19 vaccines, which adds confidence in its safety. While the new versions in this trial include variations of the original vaccine, they rely on the same proven technology.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the mRNA-1273 variant-containing formulation because it offers a tailored approach to COVID-19 protection by incorporating new mRNA sequences designed to target emerging virus variants. Unlike existing vaccines that were developed based on the original strain of the virus, this treatment aims to provide broader and potentially more effective immunity against variants like mRNA-1273.167, mRNA-1273.712, and mRNA-1273.251. This adaptability may help enhance vaccine effectiveness and keep up with the virus's evolution, offering a significant advantage in controlling the pandemic.
What is the effectiveness track record for the mRNA-1273 variant-containing formulation against COVID-19?
Research has shown that the mRNA-1273 vaccine, also known as Spikevax, is highly effective at preventing COVID-19, achieving a 94.1% success rate in preventing illness, including severe cases. This vaccine has been widely used and has proven effective in real-world settings, not just in laboratories. In this trial, participants will receive an intramuscular injection of a variant-containing formulation of mRNA-1273 (mRNA-1273.167, mRNA-1273.712, or mRNA-1273.251) to test its effectiveness against new COVID-19 variants. The goal is to ensure it continues to protect people as the virus evolves.23467
Are You a Good Fit for This Trial?
This trial is for adults who've already had an mRNA COVID-19 vaccine and can follow the study rules. They must not be pregnant, have a negative pregnancy test before getting the shot, and use birth control or abstain from sex that could lead to pregnancy from 28 days before until 28 days after vaccination.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an intramuscular (IM) injection of a mRNA-1273 variant-containing formulation
Follow-up
Participants are monitored for immunogenicity and safety after receiving the vaccine
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1273 Variant-containing Formulation
mRNA-1273 Variant-containing Formulation is already approved in European Union, United States, Canada, Switzerland, United Kingdom for the following indications:
- Prevention of COVID-19
- Prevention of COVID-19
- Prevention of COVID-19
- Prevention of COVID-19
- Prevention of COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris