A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Launched by MODERNATX, INC. · Oct 7, 2021
Trial Information
Current as of April 28, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying an experimental vaccine called mRNA-1647 to see how well it works, how safe it is, and how well it helps the body build immunity against Cytomegalovirus (CMV) in healthy female participants aged 16 to 40. The main focus is on women who do not currently have CMV, as they are at risk of exposure, especially if they have close contact with young children. The study will also look at participants over a longer period to understand how long the vaccine's effects last.
To be eligible for this trial, participants should be at least 20 years old, have close contact with children under 5, and must not be currently infected with CMV based on screening tests. Women who can become pregnant will need to take precautions to avoid pregnancy during the study. Participants will receive a vaccine or placebo (a fake treatment) and will attend regular follow-ups for about 30 months to monitor their health and immune response. It's important to know that this study is currently active but not recruiting new participants.
Gender
FEMALE
Eligibility criteria
- Key Inclusion Criteria:
- • Participants aged ≥20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
- • CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
- • CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
- • Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
- • Female participants of child-bearing potential: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active with men, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).
- Extension substudy:
- • All consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at baseline and did not seroconvert during the main study, received at least one injection of either mRNA-1647 or placebo, and completed the final study visit in the main study.
- • Consenting participants in mRNA-1647-P301 main study who were CMV-seropositive at baseline, received all 3 study injections, and completed the final study visit in the main study.
- Key Exclusion Criteria:
- • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- * Received or plans to receive any nonstudy vaccine \<28 days prior to and after any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
- • Any COVID-19 primary vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
- • COVID-19 vaccines (including any booster dose, regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
- • Influenza vaccines may be administered \> 14 days prior to or after any study injection.
- • Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
- • Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) \<2 weeks prior to the day of first injection or plans to do so during the course of the study.
- • Previous receipt of an investigational CMV vaccine.
- • Receipt of systemic immunoglobulins or blood products \<3 months prior to the day of first injection.
- • Participated in an interventional clinical study \<28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
- • Participant has donated ≥450 milliliters (mL) of blood products \<28 days prior to Screening.
- • Participant is a member of study team or is an immediate family member or household member of study personnel.
- Extension substudy:
- • Receipt of any CMV vaccine other than mRNA-1647.
- • Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
About Modernatx, Inc.
ModernaTX, Inc. is a pioneering biotechnology company focused on developing transformative medicines based on messenger RNA (mRNA) technology. Established with a commitment to addressing unmet medical needs, Moderna leverages its proprietary platform to create innovative therapies and vaccines for a variety of diseases, including infectious diseases and cancer. The company gained global recognition for its rapid development of an mRNA-based COVID-19 vaccine, showcasing its agility and expertise in the biopharmaceutical landscape. Through robust clinical trials and a commitment to scientific excellence, ModernaTX aims to redefine the future of medicine and enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonton, Alberta, Canada
Parkville, Victoria, Australia
Stanford, California, United States
Barcelona, , Spain
Oklahoma City, Oklahoma, United States
Syracuse, New York, United States
Ottawa, Ontario, Canada
Geelong, Victoria, Australia
Pierre Bénite, , France
Paris, , France
San Antonio, Texas, United States
Kfar Saba, , Israel
Bonn, Nordrhein Westfalen, Germany
Madison, Wisconsin, United States
Valley Village, California, United States
Petah Tikva, , Israel
Layton, Utah, United States
Renton, Washington, United States
Tours, , France
Liège, , Belgium
Austin, Texas, United States
Salt Lake City, Utah, United States
Middlesbrough, Cleveland, United Kingdom
Halifax, Nova Scotia, Canada
Paris, , France
Montpellier, , France
Barcelona, Catalonia, Spain
Sacramento, California, United States
Merewether, New South Wales, Australia
Kfar Saba, , Israel
Little Rock, Arkansas, United States
Tomball, Texas, United States
Limoges, , France
Columbus, Georgia, United States
Montreal, Quebec, Canada
Toronto, Ontario, Canada
Leipzig, , Germany
Kanwal, New South Wales, Australia
Columbus, Ohio, United States
Sydney, New South Wales, Australia
Sippy Downs, Queensland, Australia
Peoria, Illinois, United States
Doral, Florida, United States
Decatur, Georgia, United States
Madrid, , Spain
Genova, , Italy
Edmonton, Alberta, Canada
Sarnia, Ontario, Canada
Corby, Northamptonshire, United Kingdom
Santa Clarita, California, United States
Long Beach, California, United States
Phoenix, Arizona, United States
Gulfport, Mississippi, United States
North Charleston, South Carolina, United States
Miami, Florida, United States
Miami, Florida, United States
Coffs Harbour, New South Wales, Australia
Charlotte, North Carolina, United States
Norcross, Georgia, United States
Pomona, California, United States
Saint Priest En Jarez, , France
Seattle, Washington, United States
South Euclid, Ohio, United States
Fargo, North Dakota, United States
Oak Brook, Illinois, United States
Morehead City, North Carolina, United States
Guntersville, Alabama, United States
Cincinnati, Ohio, United States
Camberwell, , Australia
Phoenix, Arizona, United States
Birmingham, Alabama, United States
Austin, Texas, United States
Red Oak, Texas, United States
Blacktown, New South Wales, Australia
West Jordan, Utah, United States
Newton, Kansas, United States
Nedlands, Western Australia, Australia
Meridian, Idaho, United States
Southfield, Michigan, United States
Las Vegas, Nevada, United States
Medford, Oregon, United States
Dallas, Texas, United States
Banning, California, United States
Phoenix, Arizona, United States
Binghamton, New York, United States
Victoria, Texas, United States
Pierrefonds, Quebec, Canada
Brookvale, New South Wales, Australia
La Mesa, California, United States
Omaha, Nebraska, United States
Morayfield, Queensland, Australia
Lexington, Kentucky, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Chula Vista, California, United States
La Mesa, California, United States
La Mesa, California, United States
Redding, California, United States
Milford, Connecticut, United States
Coral Springs, Florida, United States
Edgewater, Florida, United States
Hialeah, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chamblee, Georgia, United States
Dacula, Georgia, United States
Kennesaw, Georgia, United States
Mcdonough, Georgia, United States
Newnan, Georgia, United States
Sandy Springs, Georgia, United States
Savannah, Georgia, United States
Lenexa, Kansas, United States
Metairie, Louisiana, United States
Rockville, Maryland, United States
Methuen, Massachusetts, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Petal, Mississippi, United States
Grand Island, Nebraska, United States
Hastings, Nebraska, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Irvington, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Fayetteville, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Yukon, Oklahoma, United States
Austin, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Cedar Park, Texas, United States
Frisco, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Missouri City, Texas, United States
Pflugerville, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Suffolk, Virginia, United States
Bruce, Australian Capital Territory, Australia
Southbank, Queensland, Australia
Mirabel, Quebec, Canada
Pointe Claire, Quebec, Canada
Québec City, Quebec, Canada
Saint Charles Borromée, Quebec, Canada
Sherbrooke, Quebec, Canada
Victoriaville, Quebec, Canada
Levis, , Canada
Tallinn, Harjumaa, Estonia
Tallinn, Harjumaa, Estonia
Tallinn, Harjumaa, Estonia
Paide, Järvamaa, Estonia
Tartu, Tartumaa, Estonia
Seinäjoki, Etelä Pohjanmaa, Finland
Helsinki, Etelä Suomen Lään, Finland
Kokkola, Keski Pohjanmaa, Finland
Oulu, Oulun Lääni, Finland
Tampere, Pirkanmaa, Finland
Pori, Satakunta, Finland
Espoo, Uusimaa, Finland
Helsinki, Uusimaa, Finland
Järvenpää, Uusimaa, Finland
Turku, Västra Finlands Län, Finland
Cordoba, Andalusia, Spain
Sevilla, Andalusia, Spain
Barcelona, Catalonia, Spain
Santiago De Compostela, Galicia, Spain
London, England, United Kingdom
Des Moines, Iowa, United States
Tucson, Arizona, United States
Dallas, Texas, United States
Tempe, Arizona, United States
Leipzig, , Germany
Coconut Creek, Florida, United States
Montclair, California, United States
Parkville, Victoria, Australia
Camberwell, , Australia
Brugge, West Vlaanderen, Belgium
Toronto, Ontario, Canada
Levis, Quebec, Canada
Haifa, Haifa Hefa, Israel
Tel Aviv, Tel Aviv District, Israel
Jerusalem, Yerushalayim Al Quds, Israel
Tel Aviv, , Israel
Edgewater, Florida, United States
Sydney, North South Wales, Australia
Melbourne, Victoria, Australia
Burlington, Ontario, Canada
München, , Germany
Weinheim, , Germany
Monza, , Italy
London, England, United Kingdom
Southampton, , United Kingdom
Mesa, Arizona, United States
Miami Lakes, Florida, United States
Funabashi Shi, Chiba, Japan
Fukuoka Shi, Fukuoka, Japan
Sapporo Shi, Hokkaido, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Sakai Shi, Osaka, Japan
Kawagoe Shi, Saitama, Japan
Chuo Ku, Tokyo, Japan
Shibuya Ku, Tokyo, Japan
Taito Ku, Tokyo, Japan
Marietta, Georgia, United States
Chandler, Arizona, United States
Gent, Oost Vlaanderen, Belgium
Geseke, North Rhine Westphalia, Germany
Osaka Shi Osaka, Kansai, Japan
Fukuoka Shi Fukuoka, Kyushu, Japan
Lincoln, Nebraska, United States
Long Beach, California, United States
Dothan, Alabama, United States
Little Rock, Arkansas, United States
North Hollywood, California, United States
San Diego, California, United States
Thousand Oaks, California, United States
West Covina, California, United States
Aurora, Colorado, United States
Wheat Ridge, Colorado, United States
Washington, District Of Columbia, United States
Columbus, Georgia, United States
Idaho Falls, Idaho, United States
Hammond, Indiana, United States
Burlington, Massachusetts, United States
Southfield, Michigan, United States
Great Falls, Montana, United States
Missoula, Montana, United States
Monroe, North Carolina, United States
Houston, Texas, United States
Mcallen, Texas, United States
Pharr, Texas, United States
Toronto, Ontario, Canada
Levis, Quebec, Canada
Mirabel, Quebec, Canada
Pointe Claire, Quebec, Canada
Helsinki, Etelä Suomen Lään, Finland
Espoo, Uusimaa, Finland
Helsinki, Uusimaa, Finland
Järvenpää, Uusimaa, Finland
La Roche Sur Yon, , France
Hamburg, , Germany
Leipzig, , Germany
Habikino Shi, Osaka, Japan
Toyama Shinjuku, Tokyo, Japan
Panama City, Florida, United States
Ormond Beach, Florida, United States
Birmingham, Alabama, United States
Saint Petersburg, Florida, United States
Metairie, Louisiana, United States
Brookline, Massachusetts, United States
Kalispell, Montana, United States
Dayton, Ohio, United States
Beaumont, Texas, United States
El Paso, Texas, United States
Botany, North South Wales, Australia
Camberwell, Victoria, Australia
Nantes, Pays De La Loire, France
Stuttgart, Baden Württemberg, Germany
Oldenburg In Holstein, Schleswig Holstein, Germany
Reinfeld, Schleswig Holstein, Germany
Berlin, , Germany
Hamburg, , Germany
Monza, , Italy
Shinjuku, Tokyo, Japan
Malaga, Andalusia, Spain
Centelles, Catalonia, Spain
Mostoles, Madrird, Spain
Hialeah, Florida, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Fair Oaks, California, United States
Rolling Hills Estates, California, United States
Aurora, Colorado, United States
Bridgeport, Connecticut, United States
Coral Gables, Florida, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Mishawaka, Indiana, United States
Elkridge, Maryland, United States
Canton, Michigan, United States
Detroit, Michigan, United States
E. Amherst, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Chickasha, Oklahoma, United States
Columbia, South Carolina, United States
Mount Pleasant, South Carolina, United States
Beaumont, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Keller, Texas, United States
Plano, Texas, United States
Waxahachie, Texas, United States
Riverton, Utah, United States
Spokane, Washington, United States
Mainz, Rhineland Palatinate, Germany
Delitzsch, Sachsen, Germany
Hamburg, , Germany
Petah Tiqva, Central District Of Israel, Israel
Be'er Ya'akov, Rishon Lezion, Israel
Kobe Shi, Hyôgo, Japan
Bristol, South West England, United Kingdom
Fullerton, California, United States
Beer Sheva, Tel Aviv District, Israel
Jerusalem, Yerushalayim Al Quds, Israel
Newcastle Upon Tyne, Northumberland, United Kingdom
Beer Yaakov, Rishon Lezion, Israel
Kobe Shi, Hyôgo, Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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