Moderna

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

Help prevent CMV.

A vaccine study.

A study to test an investigational vaccine that may protect women from cytomegalovirus (CMV) infection

CMV is a common virus throughout the world. It will infect most people at some time in their life. In healthy children and adults, the virus usually causes no symptoms and poses no threat to their health. However, CMV is a concern when it is transmitted from a pregnant woman and infects her unborn child (this is called congenital CMV infection). CMV is the most common congenital viral infection in the United States. Some babies born with congenital CMV infection develop problems such as hearing loss, learning problems, or vision abnormalities, and can even die from this virus in the most severe cases.

Trial Details

Moderna is studying a potential vaccine for the prevention of cytomegalovirus (also called CMV). Clinical research studies and the volunteers who take part in research studies are vital to creating vaccines that will safely protect people from all ages and backgrounds against viruses.

The purpose of this research study is to understand how the body responds to different doses of the mRNA-1647 investigational vaccine that may protect women against CMV. This study will specifically look for any side effects of the vaccine and whether or not an immune response is generated. Results from this study will be used to select the best dose of the mRNA-1647 vaccine to be used in future studies.

Estimated Enrollment

250 female participants

Phase

Eligibility Criteria

Participants must be:

Women between the ages of 18-40
In good health

Participants must not:

Be pregnant, breast feeding or planning to become pregnant within the next year
Have been given a prior vaccine for CMV
Have participated in another study within the past month

What to Expect

The total length of trial participation is approximately a year and a half (18 months) and includes 12 visits to the study clinic and 6 scheduled telephone calls with the study staff.

Study volunteers will be given three injections in the upper arm over a six-month timeframe. Each study volunteer has a 75% chance of receiving the mRNA-1647 study vaccine and a 25% chance of receiving the placebo (like flipping a coin).
After the study volunteers receive their first dose, they will come back to the research clinic 10 times over the next year and a half.

Study volunteers have the right to stop participation in the study at any time and do not have to give a reason. Insurance is not needed to join this research study, and compensation for your time will be provided.

You will need to travel to one of the 9 sites taking part in this clinical trial. Sites are located in:

Actively Recruiting

Lexington, Kentucky, United States
Salt Lake City, Utah, United States
Columbus, Ohio, United States
Victoria, Texas, United States

Not yet Recruiting

(Awaiting confirmation) Lenexa, Kansas, United States
(Awaiting confirmation) Austin, Texas, United States
(Awaiting confirmation) Peoria, Illinois, United States
(On hold) Sacramento, California, United States

The study vaccine is investigational as effectiveness and safety have not been established. There is no guarantee that the study vaccine will become commercially available.

Potential Benefits

Your participation could contribute to a potential CMV vaccine.
Help others through advancing knowledge about CMV and a potential vaccine.
Receive close monitoring and health wellness visits with the study staff.

Potential Risks

The study vaccine may cause side effects such as pain at the injection site, headache, and muscle/joint pain.
There may be unknown side effects of the study vaccine (short and long term).
Taking part in a research study may have an impact on your daily schedule.

You will be monitored for risks and side effects throughout your participation in the study. You should contact the study doctor if you think you are having side effects or experiencing a change in your medical condition.

Frequently Asked Questions (FAQ)

What is cytomegalovirus (CMV)?

CMV is a common virus throughout the world. It will infect most people at some time in their life. In healthy children and adults, the virus usually causes no symptoms and poses no threat to their health. CMV is a concern because it can lead to health problems when unborn babies or people with weakened immune systems are infected. CMV is spread from one person to another when there is contact with fluids from the body, such as saliva. CMV is not transmitted in the air. CMV can also be transmitted from a pregnant woman to her unborn child. CMV is the most common viral infection passed from mother to unborn child and leading cause of birth defects due to infection in the United States. Some babies born with CMV infection develop problems such as hearing loss, learning problems, or vision abnormalities and can even die in the most severe cases.

The best option to prevent CMV is the use of a safe and effective vaccine to protect women from CMV infection and potentially passing CMV infection to their unborn child if exposed during pregnancy.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Will I get paid to participate in this study?

Yes, you will be compensated for your time and for each study visit you complete.

What does a typical clinical trial look like?

Clinical trials are scientific studies that help to determine if and how new treatments work. A research plan or protocol is created that outlines how trial participants may receive the treatment being tested. The trial may compare the experimental treatment to a standard treatment for the illness, to a placebo with no active medication, or to no intervention at all. The trial team will share more details before you participate. For more information about this trial, please see the ‘What to Expect’ section of this website.

What does the phase of a study mean?

In general, a study's "phase" identifies it's purpose.

A Phase 1 study tests whether or not a vaccine is safe, and if the body's immune system responds to the vaccine in a small number (20-100) of healthy volunteers.
A Phase 2 study tests for safety and for the body's immune response to find the best dose of the vaccine in hundreds of healthy volunteers. This study is a Phase 2 study.
A Phase 3 study tests for safety, and also if the vaccine actually prevents infection in a large number of volunteers (>1000).

A vaccine may be approved by the Food and Drug Administration (FDA) only if the goals are met in all of the study phases.

Can I stop the trial at any time?

You can leave the study at any time by telling your study doctor that you no longer want to take part. Your choice will not change the quality of care you receive outside of this study.

Does the mRNA-1647 study vaccine contain a live virus?

Normally, vaccines for viruses are made from a weakened or inactive virus. However, the mRNA study vaccine is different. It is made from molecules called mRNA that tell cells how to make specific proteins. In this case, the proteins are two small parts of the virus that do not cause CMV illness but help the body's immune system recognize and protect itself if it comes in contact with infectious CMV virus. Basically, you make your own vaccine.

You cannot become infected with CMV from receiving the study vaccine.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information.

Your name, address, telephone number, health insurance number where applicable.
Your age, gender, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples and any images taken.

Who has access to your personal information?

All your personal information collected for this study will be stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Citeline to contact you about clinical trials and related information.