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This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-finding Phase | Experimental | Participants will receive mRNA-1982 or placebo as an intramuscular injection. |
|
| Booster Phase | Experimental | Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1982 | Biological | Suspension for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions | Day 1 up to Day 7 (7 days post-injection) | |
| Both Phases: Number of Participants with Unsolicited Adverse Events | Day 1 up to Day 28 (28 days post-injection) | |
| Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation | Day 1 up to Month 21 (End of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab) | Days 1, 113, 197, 265, and 349 | |
| Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | Contact | 1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colchester Research Group | Recruiting | Truro | Nova Scotia | B2N 1L2 | Canada | |
| Bluewater Clinical Research Group Inc. |
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| Placebo |
| Biological |
Suspension for injection |
|
| Days 113, 197, 265, and 349 |
| Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab | Days 1, 29, and 181 of Booster Phase |
| Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab | Days 29 and 181 of Booster Phase |
| Recruiting |
| Sarnia |
| Ontario |
| N7T 4X3 |
| Canada |
| Stouffville Medical Research Institute Inc. | Recruiting | Stouffville | Ontario | L4A 1H2 | Canada |
| Dr. Anil K. Gupta Medicine Professional Corporation Inc. | Recruiting | Toronto | Ontario | M9V 4B4 | Canada |
| Diex Recherche Inc. - Division Joliette | Recruiting | Joliette | Quebec | J6E 6A9 | Canada |
| Diex Recherche Inc. - Division Sherbrooke | Recruiting | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Diex Recherche Inc. - Division Victoriaville | Recruiting | Victoriaville | Quebec | G6P 3Z8 | Canada |
| Diex Recherche Inc. - Division Quebec | Recruiting | Québec | G1V 4T3 | Canada |
| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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