Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04232280 |
Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : October 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cytomegalovirus Infection | Biological: mRNA-1647 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 452 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Observer-Blind |
Primary Purpose: | Prevention |
Official Title: | A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults |
Actual Study Start Date : | December 23, 2019 |
Estimated Primary Completion Date : | May 31, 2022 |
Estimated Study Completion Date : | May 31, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: CMV-seronegative
Escalating dose levels
|
Biological: mRNA-1647
Cytomegalovirus vaccine Other: Placebo Saline |
Experimental: CMV-seropositive
Escalating dose levels
|
Biological: mRNA-1647
Cytomegalovirus vaccine Other: Placebo Saline |
- Frequency of solicited local and systemic adverse reactions (ARs) [ Time Frame: 7 days following each dose administration ]
- Frequency of unsolicited adverse events (AEs) [ Time Frame: 28 days following each dose administration ]
- Frequency of medically-attended adverse events (MAAEs) [ Time Frame: 6 months following the last dose administration ]
- Frequency of serious adverse events (SAEs) [ Time Frame: One year following the last dose administration ]
- Change in geometric mean titer (GMT) of serum neutralizing anti-CMV antibodies against epithelial cell infection and against fibroblast infection [ Time Frame: Up to Day 504 ]
- Percentage of participants with ≥ 2-fold, 3-fold, and 4-fold increases in neutralizing antibodies over baseline against epithelial cell infection and against fibroblast infection [ Time Frame: Up to Day 504 ]
- GMT of anti-gB specific IgG and anti-Pentamer specific IgG as measured by enzyme-linked immunosorbent assay (ELISA), and associated GMR of post-baseline/baseline titers [ Time Frame: Day 1, 29, 56, 84, 168, 196, 336, and 504 ]
- GMT, GMR, and proportion of participants with ≥ 2-fold, 3-fold, and 4-fold increases over baseline of serum nAb against epithelial cell infection and against fibroblast infection [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]
- GMT and GMR of antigen-specific IgG (ELISA) in the CMV-seropositive group [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]
- GMT and GMR of antigen-specific IgG (ELISA) in the CMV-seronegative group [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
- Understands and agrees to comply with the trial procedures and provides written informed consent
- According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
- Body mass index (BMI) 18-35 kg/m^2
- Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 30 days prior to enrollment and through 3 months following last vaccination
- Male subjects must agree to practice adequate contraception for 30 days prior to the first vaccination and through 3 months following the last vaccination
Exclusion Criteria:
- Acutely ill or febrile on the day of the first vaccination
- Prior receipt of any CMV vaccine
- Abnormal screening safety laboratory test results
- Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures
- Has received or plans to receive a vaccine ≤ 28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered > 14 days before or after any study vaccination
- Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
- Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
- Previous receipt of medications in lipid nanoparticle (LNP) formulation
- Has donated ≥ 450 mL of blood products within 28 days of the Screening visit
- Participated in an interventional clinical trial within 28 days prior to the day of enrollment
- Is an immediate family member or household member of trial personnel

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232280
Contact: Moderna Clinical Trials | 855-663-6762 | clinicaltrials@modernatx.com |
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Austin, Texas, United States, 78745 | |
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Victoria, Texas, United States, 77901 | |
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Tanner Clinic | Not yet recruiting |
Layton, Utah, United States, 84041 | |
Foothill Family Clinic | Recruiting |
Salt Lake City, Utah, United States, 84109 | |
Foothill Family Clinic-South Clinic | Recruiting |
Salt Lake City, Utah, United States, 84121 |
Responsible Party: | ModernaTX, Inc. |
ClinicalTrials.gov Identifier: | NCT04232280 |
Other Study ID Numbers: |
mRNA-1647-P202 |
First Posted: | January 18, 2020 Key Record Dates |
Last Update Posted: | October 20, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Moderna mRNA-1647 Cytomegalovirus CMV Cytomegalovirus Vaccine Cytomegalovirus Infections |
Cytomegalovirus Congenital Virus Diseases Infection Viral DNA Virus Infections Messenger RNA |
Infection Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |