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
University of Alberta Hospital Edmonton, Alberta Canada T6G 2B7
Applied Research Center of Arkansas Little Rock , AR United States 72212
Hope Research Institute LLC - Peoria Peoria, Arizona United States 85381
Hope Research Institute LLC - Hunt - Phoenix Phoenix, Arizona United States 85018
Hope Research Institute LLC - Hunt - Tempe Tempe, Arizona United States 85284
Noble Clinical Research - Tuscon Tucson, Arizona United States 85704
Chandler Clinical Trials, LLC Chandler, Arizona United States 85224
Preferred Research Partners - Little Rock Little Rock, Arkansas United States 72211
Baptist Health Center for Clinical Research - Little Rock Little Rock, Arkansas United States 72205
Paratus Clinical Research - Canberra Bruce, Australian Capital Territory Australia 2617
Arizona Clinical Trials Messa, AZ USA 85210
Care Access Research - Salt Lake City Santa Clarita, CA United States 91321
Long Beach Research Institute, LLC Long Beach, California USA 03300
Women’s Healthcare Research San Diego, California United States 92111
Paradigm Clinical Research Institute - La Mesa La Mesa, California United States 91942
Clinical Trials Management Services, LLC - Thousand Oaks Thousand Oaks, California USA 91360
Velocity Clinical Research - La Mesa La Mesa, California United States 91942
Velocity Clinical Research - Chula Vista Chula Vista, California United States 91911
Next Level Clinical Trials West Covina, California United States 91790
Paradigm Clinical Research - Redding Redding, California United States 96001
Bayview Research Group - Valley Village Valley Village, California United States 91607
Velocity Clinical Research - Banning Banning, California United States 92220
Care Access Research - Salt Lake City Aurora, CO United States 80012
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
Precision Clinical Research - Sunrise Sunrise, Florida United States 33351
Riverside Clinical Research - Edgewater Edgewater, Florida United States 32132
CVS Health Hub - Kennesaw Kennesaw, Georgia United States 30152
Tekton Research - Chamblee Chamblee, Georgia United States 30341
CVS Health Hub - Mcdonough McDonough, Georgia United States 30253
CVS Health Hub - Dacula Dacula, Georgia United States 30019
CVS Health Hub - Atlanta Atlanta, Georgia United States 30329
CVS Health Hub - Newnan Newnan, Georgia United States 30265
CVS Health Hub - Savannah Savannah, Georgia United States 31405
CVS Health Hub - Atlanta/ MLK Atlanta, Georgia United States 30311
iResearch Atlanta - Decatur Decatur, Georgia United States 30030
Velocity Boise Meridian, ID United States 86342
Affinity Health - Oak Brook Oak Brook, IL United States 60523
ASHA Clinical Reseach Hammond, IN United States 46324
Iowa Clinic - West Des Moines West Des Moines, Iowa United States 50233
Heartland Research - Newton Newton, Kansas United States 67114
Johnson County Clinical Trials - Lenexa Lenexa, Kansas United States 66219
Alliance for Multispecialty Research - Lexington Lexington, Kentucky United States 40509
MedPharmics - Metaire Metairie, Louisiana United States 70006
Skylight Health Research – Burlington Burlington, MA United States 01803
Meridian Clinical Research - Rockville Rockville, Maryland United States 20854
ActiveMed Practices & Research - Methuen Methuen, Massachusetts United States 01844
Great Lakes Research Institute Southfield, MI United States 48075
University of Minnesota - Minneapolis Minneapolis, Minnesota United States 55454
Clinical Research Institute - Minneapolis Minneapolis, Minnesota United States 55402
MediSync Clinical Research Hattiesburg Clinic - Petal Petal, Mississippi United States 39465
MedPharmics - Gulfport Gulfport, Mississippi United States 39503
Boeson Research MSO - Missoula Missoula, Montana USA 59804
Meridian Clinical Research - Hastings Hastings, Nebaska United States 68901
Meridian Clinical Research - Omaha Omaha, Nebraska United States 68114
Quality Clinical Research - Omaha Omaha, Nebraska United States 68114
Meridian Clinical Research - Norfolk Norfolk, Nebraska United States 68701
Meridian Clinical Research - Grand Island Grand Island, Nebraska United States 68803
Albuquerque Clinical Trials - Albuquerque Albequerque, New Mexico United States 87102
MedPharmics - Albuquerque Albuquerque, New Mexico United States 87102
Paratus Clinical Research - Western Sydney Kanwal, New South Wales Australia 2259
Paratus Clinical Research - Central Coast Kanwal, New South Wales Australia 2259
Meridian Clinical Research - Endwell Binghamton, New York United States 13901
Rochester Clinical Research - Rochester Rochester, New York United States 14609
OnSite Clinical Solutions - Charlotte Charlotte, North Carolina United States 28277
M3 Wake Research - Raleigh Raleigh, North Carolina United States 27612-8106
Lucas Research - Morehead City Morehead City, North Carolina United States 28557
Lillestol Research - Fargo Fargo, North Dakota United States 58104
PriMed Physicians - Dayton Dayton, Ohio United States 45419
ClinOhio Research Services - Columbus Columbus, Ohio United States 43213
CTI Clinical Research Center - Cincinnati Cincinnati, Ohio United States 45212
Meridian Clinical Research - Cincinnati Cincinnati, Ohio United States 45219
Aventiv Research - Columbus Columbus, Ohio United States 43213
Tekton Research - Yukon Yukon, Oklahoma United States 73099
Lynn Health Science Institute - Oklahoma City Oklahoma City, Oklahoma United States 73112
LMC Manna Research - Burlington Burlington, Ontario Canada L7M 4Y1
Dr. Anil K. Gupta Medicine Professional Corporation Toronto, Ontario Canada M9V 4B4
Centricity Research - Toronto Toronto, Ontario Canada M9W 4L6
LMC Manna Research - Levis Levis, Quebec Canada G6W 0M5
LMC Manna Research - Point-Claire Point-Claire, Quebec Canada H9R 4S3
LMC Manna Research - Mirabel Mirabel, Quebec Canada J7J 2K8