Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

This research is a Phase 3 study, which means it's a large trial to confirm if a new vaccine for cytomegalovirus (CMV) is effective and safe. The vaccine is called mRNA-1647. Healthy volunteers between 16 and 40 years old will take part. Participants will be randomly assigned to receive either the vaccine or a dummy injection (placebo), and neither they nor the study staff will know who got what. Researchers will carefully check if the vaccine prevents the first CMV infection, how common side effects are, and how the body’s immune system responds. This study aims to find out if this vaccine could help protect people from CMV.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Moderna Inc.

Enrolment target

1,853

Start

16 Feb 2024

Cytomegalovirus Infection (CMV)

What is this study about?

Cytomegalovirus (CMV) is a common virus that most people get at some point in their lives. Often, it causes no symptoms or only mild ones, like a cold. However, for some people, especially those with weakened immune systems, or babies born with the infection (congenital CMV), it can cause serious health problems.

This study is looking at a new vaccine called mRNA-1647. The goal is to see if this vaccine can prevent people from getting their first CMV infection. By preventing the initial infection, we hope to reduce the risk of serious CMV-related health issues. This is a "Phase 3" study, which means it’s a big, final trial to check if the vaccine works well and is safe before it could potentially be made available to everyone.

Healthy people aged 16 to 40 years old are invited to take part. Participants will be randomly assigned to receive either the new vaccine or a harmless salt-water injection (a placebo). This helps researchers fairly compare the two groups without bias. Neither the participants nor the research team will know who receives the vaccine and who receives the placebo. This setup helps us get the most accurate results on the vaccine's effectiveness and safety.

Key takeaways

This study tests a new vaccine (mRNA-1647) for CMV.
It aims to prevent first-time CMV infection in healthy adults.
Participants will be aged 16 to 40 years old.
You might receive the vaccine or a harmless dummy injection.
Your health will be closely monitored throughout the study.
Participation helps scientists learn if the vaccine is safe and effective.

Who may be eligible?

To join this study, you need to be a healthy person between 16 and 40 years old.

There might be other health requirements or reasons why you couldn't join, which the study team would discuss with you. For example, certain medical conditions or medications might prevent you from taking part.

It’s important to remember that being eligible doesn't mean you have to join. The research team will explain everything in detail, and you'll have plenty of chances to ask questions before making a decision.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 16 and 40 years old?
Are you generally in good health?
Are you able to attend appointments for injections and check-ups?
Are you comfortable with blood tests and physical examinations?
Do you understand you might receive a placebo?
Are you happy to stay in the study for several months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive several injections over a period of time. Some participants will receive the new vaccine, and others will receive a dummy injection (placebo). You won't know which one you're getting. You would have regular check-ups and provide blood samples to see if you have developed CMV or if your body has reacted to the vaccine. Researchers will also keep a close eye on any side effects you might experience. This follow-up will include detailed checks for a while after your last injection, potentially for several months, to ensure your safety and to collect all necessary information. The total length of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as contributing to medical knowledge that might help prevent CMV infections in the future. You will also receive closely monitored medical care during the study. However, like all medications, the vaccine might cause side effects, such as soreness at the injection site, fever, or other reactions, which will be carefully recorded. There's also the chance you might receive the placebo and not the active vaccine. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland
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Unverified
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Belgium
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Unverified
Germany
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Unverified
Estonia

Common questions

What is CMV?

CMV (Cytomegalovirus) is a common virus. Most people don't get sick from it, but it can be serious for some, especially those with weak immune systems or unborn babies.

What is a 'Phase 3' study?

A Phase 3 study is a large research trial that includes many people. It's designed to confirm if a new treatment or vaccine is effective, safe, and works better than existing options or a dummy treatment.

Will I get the actual vaccine or a dummy injection?

You will be randomly assigned to receive either the new vaccine or a dummy injection (placebo). Neither you nor the study team will know which one you received during the study.

How long will I need to be in the study?

The study involves several injections and regular check-ups, so your participation will last for a period of months. The exact duration will be explained by the study team.

Can I leave the study if I change my mind?

Yes, you are completely free to leave the study at any time, for any reason. Your decision will not affect your relationship with your doctor or the care you receive.