The Fresh Toast

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

2

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

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started

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 8 sites taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Victoria, Texas, US
  • Salt Lake City, Utah, US
  • Sacramento, California, US

Currently Inactive

  • (Awaiting confirmation) Lexington, Kentucky, US
  • (Awaiting confirmation) Austin, Texas, US
  • (Awaiting confirmation) Lenexa, Kansas, US
  • (Awaiting confirmation) Peoria, Illinois, US
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)

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started