Moderna Inc.

Language:

This trial is not actively recruiting.

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

A Cytomegalovirus (CMV) vaccine trial for healthy adults of Japanese descent

A clinical trial conducted by Moderna is evaluating an investigational vaccine that may protect people from CMV infection. CMV is a common virus that many adults and children contract in their lifetime. In most people, CMV doesn’t always cause symptoms, but it can be passed from a pregnant individual to their unborn child, resulting in CMV infection prior to birth (cCMV). This cCMV infection can potentially cause significant disease in infants and lifelong disability. Currently, there is no approved vaccine for the prevention of CMV infection.

Trial ID: NCT05105048

By taking part in the CMVoice trial, you could contribute to the potential development of a vaccine that may prevent CMV infection. Because certain populations respond differently to medical treatments, therapies, and vaccines, this trial is evaluating the immune response to the investigational vaccine specifically in participants of Japanese descent. Moderna is committed to researching safe and effective mRNA-based vaccines and therapies to bring better health and living to people of all ages, sexes, and backgrounds.

Trial Details

The CMVoice trial is evaluating the safety of and immune response to an investigational vaccine, called mRNA-1647, to protect against CMV infection. Participation in the CMVoice trial last up to 12 months (one year). During this time, participants will have up to approximately 11 visits to the trial site and 9 phone calls.

Estimated Enrollment

28 Participants

Phase

Eligibility Criteria

Participants must:

Be of Japanese descent (participant, both parents, and grandparents were born in Japan)
Be 18-40 years of age
Be in good health

Participants must not:

Have received or have plans to receive any non-trial vaccine within 28 days prior to or after the trial vaccination. In addition, the following apply:
- Any COVID-19 vaccination series must have been completed a minimum of 28 day prior to receiving any dose of the trial injection
- Any flu vaccine must have been completed a minimum of 14 days prior to trial injection
Have participated in another trial in the past month

What to Expect

Participation in the CMVoice trial lasts up to 12 months and includes 9 phone calls and up to 11 visits to the trial site.

Participants will be given one injection in the upper arm. Participants have a chance of receiving either the mRNA-1647 investigational vaccine or the placebo. By using a placebo, medical researchers are able to understand if the investigational vaccine is effective in protecting against CMV infection.
Participants will be asked to return to the trial site for follow up visits and will also have phone calls with the trial doctors to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.
Participants will be asked to use an eDiary app on their smartphone or a smartphone will be provided to report any symptoms the participant might experience for 7 days after the injection.
Participants will be closely monitored by the trial clinic team if any symptoms are reported at any time throughout their participation.

Insurance is not needed to join this clinical trial, and compensation for the participants trial-related time will be provided.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

What is Cytomegalovirus (CMV)?

Cytomegalovirus, shortened to CMV, is a leading cause of birth defects around the world. CMV is a common viral infection that usually goes unnoticed or only causes mild symptoms in most people. But if a individual becomes infected with CMV while they are pregnant, they can pass the infection to their unborn baby. This can cause the child to have a long-term disability due to birth defects, including hearing loss, or even death in very severe cases. Currently, there is no approved vaccine against CMV.

What is a clinical trial?

Clinical trials, or clinical research studies, are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by the FDA and other regulatory agencies in order to ensure patients’ and trial volunteers’ safety. The protocol outlines the types of trial participants to include, the schedule of trial visits and procedures, safety precautions, and what and how trial data will be analyzed.

What are the phases of clinical research?

All new potential treatments and vaccines must go through several stages of research (also called “phases”) in order to determine if the new potential treatment or vaccine is safe and effective in people. Clinical trials are usually conducted in four phases that build on one another, with each phase designed to answer certain questions.

Preclinical Research: Before testing in people, investigational treatments and vaccines undergo laboratory and animal testing to answer basic questions about safety.
Phase 1: A trial of a small number of participants to evaluate the safety and dosage of an investigational treatment or vaccine and gather information on how it interacts with the body.
Phase 2: A trial of a slightly larger group of participants to further evaluate how an investigational treatment or vaccine affects the body, gather additional safety data, and monitor side effects.
Phase 3: A trial with the largest number of participants to determine efficacy of an investigational treatment or vaccine and compare it to existing treatments, vaccines, or placebos. A Phase 3 trial continues to monitor side effects and collect safety data. This is the final step before submitting an investigational product to a regulatory agency for market approval.
Regulatory Agency Review: Regulatory agencies, such as the FDA in the United States, review data from the clinical trial and determine if the investigational treatment or vaccine is effective and safe for use in people. To get approved, the potential treatment or vaccine must be determined to provide benefits that outweigh its known and potential risks for the intended population.
Phase 4: After receiving approval, the treatment is made available for use. Phase 4 trials are used for post-marketing observation. Sometimes, they may be used to trial the medicine in a different group of people or in another illness or disease than was previously studied. Not all vaccines and treatments will require a Phase 4 trial.

Reference: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Why is diversity important in clinical trials?

Clinical trials and trial volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research trial include people of all ages, genders, races and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Yes, compensation for participants’ trial-related time will be available. The trial site will review these details with the participants.

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

Often, vaccines for viruses are made from a weakened or inactive (not live) version of the virus, but mRNA-1647 is different. It is made from an information molecule called mRNA that tells your cells how to make protein. In this case, the protein is similar to a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with CMV. You cannot become infected with CMV from receiving the investigational vaccine.

What is a placebo?

In order to understand if the trial vaccine works, medical researchers are comparing the mRNA-1647 investigational vaccine to a saltwater placebo. A placebo looks like the investigational vaccine being tested but does not contain mRNA-1647.

Neither you nor the trial doctor will know whether you receive mRNA-1647 or a placebo. Every clinical trial participant will receive the same level of quality care regardless of whether they are assigned to the investigational vaccine or the placebo.

How can I check to see if I am 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.

Can participants quit the trial at any time?

Taking part in a clinical trial is voluntary. Participants have the right to drop out of the trial at any time for any reason, or no reason at all. The trial doctor or sponsor also has the right to discontinue a participant at any time for the participant’s safety, or if the participant no longer meets the trial requirements. Your decision will in no way affect current or future treatment you receive outside the clinical trial. If you choose to participate, you will need to follow trial instructions and complete trial-related activities.