mRNA Vaccine for Cytomegalovirus (CMV)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an mRNA vaccine designed to protect against cytomegalovirus (CMV), a virus many people carry unknowingly. The goal is to determine how long the immune response lasts and whether a booster shot enhances it. Participants from the earlier phase of the study who received the vaccine (not a placebo) can join. It suits those who are either CMV-positive or CMV-negative and have previously participated in the initial study. As a Phase 2 trial, this research measures the treatment's effectiveness in a smaller group, allowing participants to contribute to important findings.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that the mRNA-1647 vaccine is likely to be safe for humans?
Previous studies have shown that mRNA-1647 is generally safe and well-tolerated. Research demonstrated that at all dose levels, it triggered immune responses specific to the substances causing an immune reaction. An independent data safety monitoring board reviewed the vaccine, conducting a thorough safety check and finding no major issues. Overall, the evidence suggests that mRNA-1647 is safe for use in humans.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the mRNA-1647 vaccine for cytomegalovirus (CMV) because it uses cutting-edge mRNA technology to train the immune system to recognize and combat the virus. Unlike traditional treatments that often involve antiviral medications, mRNA-1647 aims to prevent CMV infection by prompting the body to produce proteins that trigger an immune response against the virus. This approach is innovative because it not only targets the virus directly but also offers a preventative strategy, potentially reducing the risk of CMV-related complications in vulnerable populations.
What evidence suggests that the mRNA-1647 vaccine could be effective for cytomegalovirus?
Research has shown that the mRNA-1647 vaccine can help the body combat CMV, a virus affecting adults. Early studies found the vaccine to be generally safe. These studies also demonstrated that the vaccine could prevent CMV infection in 6% to 23% of cases, depending on the measurement of effectiveness. While these results are promising, further research is needed to fully understand the vaccine's efficacy. In this trial, participants may receive a booster dose of the mRNA-1647 vaccine to evaluate the duration of its protection and its safety, particularly with the booster dose.13678
Are You a Good Fit for This Trial?
This trial is for adults who participated in a prior CMV vaccine study (mRNA-1647-P202) and received the mRNA-1647 vaccine, not placebo. They must have completed that study, be in good health as judged by the investigator, understand and agree to follow trial procedures, and provide written consent. Those previously vaccinated with any CMV vaccine other than mRNA-1647 or with conditions affecting safety assessments or adherence to procedures cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Primary Extension Phase
Participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years to evaluate long-term immune persistence and safety.
Optional Booster Phase
Participants may opt to receive a single booster dose of the mRNA-1647 vaccine or be followed without receiving the booster.
Follow-up
Participants are monitored for safety and effectiveness after the optional booster phase.
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1647
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