Let us be the generation that stands up to cytomegalovirus (CMV), a highly contagious viral infection that can harm an unborn child. Learn more about a clinical trial for a potential vaccine.
This clinical trial is sponsored by Moderna. Moderna is studying mRNA-1647, an investigational
vaccine to understand whether it can help your immune system protect against cytomegalovirus (CMV).
The purpose of this clinical trial is to:
Evaluate the safety and efficacy of investigational vaccine (a vaccine not yet approved by a country's drug regulatory agency) mRNA-1647 against CMV
Evaluate the safety of the vaccine in women who test positive to prior exposure to CMV
What is 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 woman becomes infected with CMV while she is pregnant, she can pass the infection to her unborn baby. This can cause her child to suffer 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.
CMV is the #1
infection that causes
birth defects in the
U.S. and one of the
most common
infectious causes of
birth defects globally.
How Participation Works
The total length of participation in this clinical trial is approximately 2½ years (30 months).
Clinical trial volunteers will have a screening visit to check whether they are eligible to participate. The visit includes a wellness exam, review of your medical history, a urine pregnancy test, and some blood tests.
During the first 7 months, trial participants will attend 5 in-person visits, including 3 vaccination visits when they'll receive injections in the upper arm.
During the follow-up portion of the trial (Month 8 through Month 30), participants will have in-person visits every 3 months and will provide updates via an eDiary, may be contacted by telephone, or may be requested to come in for unscheduled visits in between such visits.
Each participant has a 50% chance of receiving the investigational vaccine and a 50% chance of receiving a placebo—like flipping a coin.
You will be compensated for your time and for each visit you complete. More information about
reimbursement can be found in the expenses section of the Patient Information and Informed Consent Form,
and your clinical trial team can also give you more details.
We will schedule your visits in a way that minimizes disruption to your work and other commitments.
Get to Know the Investigational Vaccine: mRNA-1647
The investigational vaccine may help the body's immune system recognize and protect itself if it comes into contact with CMV in the future. You cannot become infected with CMV from receiving the investigational vaccine. The investigational vaccine in this trial, mRNA-1647, is a newer type of vaccine known as an mRNA vaccine.
Map: Every virus has signature features on its surface that can trigger your immune
system. Once the features are mapped, an mRNA vaccine provides the blueprint to create the defense that
can help your body protect itself if it encounters the virus.
Read: Once your body has the blueprint, it knows exactly what to do. It reads mRNA
strands to build a defense by producing antibody proteins that are a lot like the answer key to a test.
This means the next time your immune system encounters this type of virus, it already has the answer to
help protect you.
Neutralize: Your body now knows how to neutralize the virus and is able to defend
itself against the threat if it encounters the virus in the future. The message from the blueprint that
was read is retained and recalled when needed. It's like remembering the answer from an old test without
having to re-learn the material.
Activate: Moderna is developing mRNA vaccines, like the investigational vaccine
mRNA-1647, that deliver blueprints to create the proteins that help activate immune responses against
a variety of viruses.
Get to Know the Investigational Vaccine: mRNA-1647
The investigational vaccine may help the body's immune system recognize and protect itself if it comes into contact with CMV in the future. You cannot become infected with CMV from receiving the investigational vaccine. The investigational vaccine in this trial, mRNA-1647, is a newer type of vaccine known as an mRNA vaccine.
Map: Every virus has signature features on its surface that can trigger your immune
system. Once the features are mapped, an mRNA vaccine provides the blueprint to create the defense that
can help your body protect itself if it encounters the virus.
Read: Once your body has the blueprint, it knows exactly what to do. It reads mRNA
strands to build a defense by producing antibody proteins that are a lot like the answer key to a test.
This means the next time your immune system encounters this type of virus, it already has the answer to
help protect you.
Neutralize: Your body now knows how to neutralize the virus and is able to defend
itself against the threat if it encounters the virus in the future. The message from the blueprint that
was read is retained and recalled when needed. It's like remembering the answer from an old test without
having to re-learn the material.
Activate: Moderna is developing mRNA vaccines, like the investigational vaccine
mRNA-1647, that deliver blueprints to create the proteins that help activate immune responses against
a variety of viruses.
About Clinical Trials
Vaccines aim to safely protect people against infections, and clinical trials are vital to creating vaccines. A clinical Trial can help researchers understand whether an investigational vaccine is safe and effective. By participating in the CMVictory Trial, you can help create a future where we may hopefully declare victory and prevent the spread of CMV.
Moderna is committed to keeping people at the center of everything we do as we continue to explore what is possible through mRNA science. Without people like you, researching potential new treatments and mRNA vaccines would not be possible.
We are proud to partner with the following groups and organizations in the fight for victory against CMV:
Who May Take Part
This clinical trial is looking for volunteers. To join this clinical trial, you must be:
A woman between 16-40 years of age
In good health
In close contact with at least one child 5 years of age or younger for at least 8 hours a week, if age 20 or older
Not pregnant or planning on becoming pregnant within the next 9 months
Clinical trial staff will explain any additional requirements and answer any questions you or a loved one may have about participation. You may stop participation in the clinical trial at any time, and you do not have to give a reason for doing so.
Diseases do not discriminate— and neither should clinical trials.
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.
The CMVictory Trial will take place at locations (or sites) all around the world. Use this site locator to search for the site closest to you—as well as their contact information.
Find a location near you.
The University of Melbourne Carlton, Australia 3010
SEC Clinical Research LLC - Dothan - ClinEdge Dothan, Alabama United States 36305
Accel Research Site - Achieve - Birmingham Birmingham, Alabama United States 35216
Central Research Associates Inc Birmingham, Alabama United States 35205-1605
Lakeview Clinical Research Guntersville, Alabama United States 35976-2206
University of Alberta Hospital Edmonton, Alberta Canada T6G 2B7
Applied Research Center of Arkansas Little Rock , AR United States 72212
Hope Research Institute LLC - Hunt - Phoenix Phoenix, Arizona United States 85018
Noble Clinical Research - Tuscon Tucson, Arizona United States 85704
Hope Research Institute LLC - Hunt - Tempe Tempe, Arizona United States 85284
Hope Research Institute LLC - Peoria Peoria, Arizona United States 85381
Chandler Clinical Trials, LLC Chandler, Arizona United States 85224
Baptist Health Center for Clinical Research - Little Rock Little Rock, Arkansas United States 72205
Preferred Research Partners - Little Rock Little Rock, Arkansas United States 72211
Paratus Clinical Research - Canberra Bruce, Australian Capital Territory Australia 2617
Arizona Clinical Trials Messa, AZ USA 85210
Bayview Research Group - Valley Village Valley Village, California United States 91607
Clinical Trials Management Services, LLC - Thousand Oaks Thousand Oaks, California USA 91360
Carbon Health- NoHo West Urgent Care and Primary Care North Hollywood, California USA 91606
Velocity Clinical Research - Banning Banning, California United States 92220
Velocity Clinical Research - Chula Vista Chula Vista, California United States 91911
Care Access Research - Santa Clarita Santa Clarita, California United States 91321
Northern California Research Corp Sacramento, California United States 95821-2640
Paradigm Clinical Research Institute - La Mesa La Mesa, California United States 91942
Long Beach Research Institute, LLC Long Beach, California United States 90805
Velocity Clinical Research - La Mesa La Mesa, California United States 91942
Apex Research Group - Fair Oaks Fair Oaks, California USA 95628
Next Level Clinical Trials West Covina, California United States 91790
Women’s Healthcare Research San Diego, California United States 92111
Empire Clinical Research Pomona, California USA 91767-1800
Paradigm Clinical Research - Redding Redding, California United States 96001
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS Wheat Ridge, Colorado United States 80033-6109
Clinical Research Consultants - Milford Milford, Connecticut United States 06460
Indago Research and Health Center - Hialeah Hialeah, Florida United States 33012
Invictus Clinical Research Group Coconut Creek, Florida United States 33073
GCP Research, Global Clinical Professionals St. Petersburg, Florida United States 33705
Emerald Coast OB/GYN Clinical Research Panama City, Florida United States 32405
Precision Clinical Research - Sunrise Sunrise, Florida United States 33351
Riverside Clinical Research - Edgewater Edgewater, Florida United States 32132
Tekton Research - Chamblee Chamblee, Georgia United States 30341
One Health Research Clinic - Norcross Norcross, Georgia USA 30093
iResearch Atlanta - Decatur Decatur, Georgia United States 30030