Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Researchers are conducting a study on an experimental vaccine called mRNA-1647 for Cytomegalovirus (CMV). CMV is a very common virus, and while usually harmless, it can cause problems in some people. This study focuses on healthy young individuals aged 9 to 25. The main goals are to find out if the vaccine is safe and how effectively it helps the body build protection against the virus. They will be testing different doses of the vaccine and comparing it to a control treatment (placebo). There will be two parts to the study: first, to work out the best dose, and then to gather more safety information. It's an important step in developing a potential new way to prevent CMV.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

ModernaTX, Inc.

Enrolment target

873

Start

07 Nov 2022

Estimated completion

15 Jan 2027

Cytomegalovirus

What is this study about?

This study is all about a new, experimental vaccine designed to protect against Cytomegalovirus, often called CMV. Most people get CMV at some point in their lives, and for many, it doesn't cause any noticeable problems. However, it can be a serious concern for unborn babies, people with weakened immune systems, and organ transplant recipients. This new vaccine, called mRNA-1647, is being tested to see if it can help prevent the virus.

The main aim of this research is to understand two key things: firstly, how safe the vaccine is, and secondly, how well it helps your body create protection (like antibodies) against CMV. They are testing it in healthy young people between 9 and 25 years old. This research will help scientists learn more about new ways to protect against CMV, which could be very important for public health.

To do this, some participants will receive the active vaccine, while others will receive a 'placebo', which looks like the vaccine but doesn't contain any active ingredients. This helps researchers fairly compare the effects. The study also explores different vaccine doses to find the most effective and safest amount. This is a crucial step in developing any new vaccine before it can be used more widely.

Key takeaways

This study is testing a new CMV vaccine called mRNA-1647.
It aims to check the vaccine's safety and how well it helps your body create protection.
Healthy young people aged 9 to 25 are invited to take part.
Participants will receive either the vaccine or a placebo.
Your blood will be tested to see if you've had CMV before.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be a healthy young person between 9 and 25 years old. Specifically, they are looking for boys and girls aged 9 to 15, or young women aged 16 to 25. An important part of checking if you can join is having a health check-up with the study doctor to make sure you're generally well and can follow the study's instructions.

Your blood will be tested for CMV. Some parts of the study need you to have never had CMV before (CMV-negative), while others are looking for people who have had it (CMV-positive). There are also specific weight requirements (based on your Body Mass Index or BMI) depending on your age. For young women who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception throughout the study and for three months afterwards.

However, you won't be able to join if you have any serious or unstable health conditions that the study doctor thinks might make it unsafe for you, affect the study results, or make it hard for you to complete the study. This includes ongoing health issues that have needed changes to your treatment or medication in the last two months.

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 generally healthy and aged between 9 and 25?
If you're a boy or girl, are you 9 to 15 years old?
If you're a young woman, are you 16 to 25 years old?
Are you able to attend regular study appointments?
Do you have a healthy weight for your age?
If you could become pregnant, are you able to use reliable contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for a period of time, though the exact number of visits isn't specified here, it's common for vaccine studies to have several appointments over many months. At these visits, you'll have health checks and blood tests. You will receive either the experimental mRNA-1647 vaccine or a placebo (a dummy injection that looks like the vaccine but has no active ingredients). This is usually given as an injection. The study will monitor your health and look at how your body responds to the vaccine or placebo. You'll need to follow the study team's instructions carefully for the duration of the study, which includes regular check-ups and potentially recording any symptoms or side effects you experience. The study is split into two parts: finding the right dose and then observing more people to gather more safety information.

Potential risks and benefits

Taking part in a study like this means helping advance medical science, which could lead to better ways to prevent CMV in the future. For you personally, there's always a chance the vaccine might offer some protection against CMV, though this is not guaranteed for an experimental treatment. However, every experimental treatment carries potential risks, such as side effects from the vaccine or placebo. These could include minor reactions like soreness or redness at the injection site, or possibly more significant reactions, which the study team would monitor closely. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (57)

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

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Verified postcode
La Mesa, United States
Velocity Clinical Research - San Diego - PPDS
Verified postcode
La Mesa, United States
Benchmark Research - Sacramento -Hypercore- PPDS
Verified postcode
Sacramento, United States
Tekton Research - Fort Collins - Platinum - PPDS
Verified postcode
Fort Collins, United States
Velocity Clinical Research (Washington)- PPDS
Verified postcode
Washington D.C., United States
Prohealth Research Center
Verified postcode
Doral, United States
University of Florida Jacksonville
Verified postcode
Jacksonville, United States
Clinical Neurosciences Solutions Inc. (Orlando-East South St)
Verified postcode
Orlando, United States
Palm Harbor Dermatology
Verified postcode
Tampa, United States
Santos Research Center
Verified postcode
Tampa, United States
Children's Healthcare of Atlanta
Verified postcode
Atlanta, United States
iResearch Atlanta - CenExel - PPDS
Verified postcode
Decatur, United States

Common questions

What is CMV?

CMV, or Cytomegalovirus, is a very common virus that most people get. It usually causes no problems, but can be serious for some people.

What is the new vaccine being tested?

The vaccine is called mRNA-1647. It's an experimental vaccine that aims to help your body build protection against CMV.

Will I definitely get the real vaccine?

No, some participants will receive the experimental vaccine, while others will receive a placebo (dummy treatment) to fairly test its effects.

Who can join the study?

Healthy young people aged 9 to 25. This includes boys and girls aged 9-15, and young women aged 16-25, often depending on their CMV status.

What would taking part involve?

It would involve health checks, blood tests, receiving injections (vaccine or placebo), and regular follow-up appointments to monitor your health.