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The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1647 | Experimental | CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule. |
|
| Placebo | Placebo Comparator | CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1647 | Biological | Lyophilized product that is reconstituted with saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 176 (7 days after each injection) | |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 197 (28 days after each injection) | |
| Number of Participants With Medically-Attended AEs (MAAEs) | Day 1 through 6 months after the last injection (up to Day 347) | |
| Number of Participants With Serious AEs (SAEs) | Day 1 through End of Study (EOS) (up to Day 347) | |
| Number of Participants With AEs of Special Interest (AESIs) | Day 1 through EOS (up to Day 347) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection | Days 1, 29, 85, 169, 197, and 347 | |
| Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection |
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Inclusion Criteria:
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. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
Participant has elevated liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP), or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at screening.
Participant has laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1 at screening.
Received or plans to receive any non-study vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
i. Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
ii. COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
iii. Influenza vaccines may be administered >14 days prior to or after any study injection.
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research | North Hollywood | California | 91606 | United States | ||
| California Research Foundation |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722750 | mRNA-1647 cytomegalovirus vaccine |
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| Placebo |
| Biological |
0.9% sodium chloride (normal saline) injection |
|
| Days 29, 85, 169, 197, and 347 |
| Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection | Days 29, 85, 169, 197, and 347 |
| GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Days 1, 29, 85, 169, 197, and 347 |
| GMFR of Anti-gB and Anti-Pentamer Specific IgG | Days 29, 85, 169, 197, and 347 |
| Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG | Days 29, 85, 169, 197, and 347 |
| San Diego |
| California |
| 92123 |
| United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |