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The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28 days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1283 Dose Level 1 | Experimental | Participants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29. |
|
| mRNA-1283 Dose Level 2 | Experimental | Participants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29. |
|
| mRNA-1283 Dose Level 3 | Experimental | Participants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29. |
|
| mRNA-1273 | Experimental | Participants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29. |
|
| Placebo / mRNA-1283 | Experimental | Participants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1283 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 36 (7 days after second dose) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 57 (28 days after second dose) | |
| Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs) | Up to Day 394 (1 year after second dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) | Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 | |
| GM of SARS-CoV-2-Specific Binding Antibody (bAb) | Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research US Phoenix Southeast, Inc. | Chandler | Arizona | 85224 | United States | ||
| Optimal Research San Diego, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37074202 | Derived | Yassini P, Hutchens M, Paila YD, Schoch L, Aunins A, Siangphoe U, Paris R. Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. Hum Vaccin Immunother. 2023 Dec 31;19(1):2190690. doi: 10.1080/21645515.2023.2190690. Epub 2023 Apr 19. |
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Participants who are offered an opportunity to receive an additional injection of mRNA-1273, will participate in an open-label part of the study.
| mRNA-1273 | Biological | Sterile liquid for injection |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer | Seroconversion measured as defined for the study. | Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 |
| San Diego |
| California |
| 92108 |
| United States |
| Optimal Research Melbourne, LLC | Melbourne | Florida | 32934 | United States |
| Optimal Research Illinois, LLC | Peoria | Illinois | 61614 | United States |
| Optimal Research Texas, LLC | Austin | Texas | 78705 | United States |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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