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This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1647 | Experimental |
| |
| mRNA-1443 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1647 | Biological | Escalating dose levels |
| |
| mRNA-1443 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of solicited AEs (local and systemic reactogenicity events) | 7 days following each dose administration | |
| Frequency of unsolicited adverse events | 29 days following each dose administration | |
| Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE) | one year following the last dose administration | |
| Frequency of clinical laboratory adverse events | 1 month following the last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample | 6 months following the last dose administration | |
| Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America | Hollywood | Florida | 33024 | United States | ||
| Advanced Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38526054 | Derived | Wu K, Hou YJ, Makrinos D, Liu R, Zhu A, Koch M, Yu W-H, Paila YD, Chandramouli S, Panther L, Henry C, DiPiazza A, Carfi A. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024 Apr 16;98(4):e0160323. doi: 10.1128/jvi.01603-23. Epub 2024 Mar 25. | |
| 38478705 |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722750 | mRNA-1647 cytomegalovirus vaccine |
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| Biological |
Escalating dose levels |
|
| Placebo | Other | Saline |
|
| 6 months following the last dose administration |
| Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample | 6 months following the last dose administration |
| Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT | 6 months following the last dose administration |
| Meridian |
| Idaho |
| 83642 |
| United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States |
| Fierro C, Brune D, Shaw M, Schwartz H, Knightly C, Lin J, Carfi A, Natenshon A, Kalidindi S, Reuter C, Miller J, Panther L. Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e668-e678. doi: 10.1093/infdis/jiae114. |
| 38324766 | Derived | Hu X, Karthigeyan KP, Herbek S, Valencia SM, Jenks JA, Webster H, Miller IG, Connors M, Pollara J, Andy C, Gerber LM, Walter EB, Edwards KM, Bernstein DI, Hou J, Koch M, Panther L, Carfi A, Wu K, Permar SR. Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. J Infect Dis. 2024 Aug 16;230(2):455-466. doi: 10.1093/infdis/jiad593. |