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The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1975: Dose 1 | Experimental | Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169. |
|
| mRNA-1975: Dose 2 | Experimental | Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169. |
|
| mRNA-1975: Dose 3 | Experimental | Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169. |
|
| mRNA-1975: Dose 4 | Experimental | Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169. |
|
| mRNA-1982: Dose 1 | Experimental | Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169. |
|
| mRNA-1982: Dose 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1975 | Biological | Dispersion delivered IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 175 (7 days after each study injection) | |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 196 (28 days after each study injection) | |
| Number of Participants With Medically Attended AEs | Day 1 through Day 337 (6 months after the last study injection) | |
| Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation | Day 1 through Day 505 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method | Days 1, 29, 85, and 197 | |
| Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | United States | ||
| Stamford Therapeutics Consortium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42086599 | Derived | Finn MB, Willsey G, Piazza CL, Clendenen L, Shrestha M, You SS, Ma L, Dhingra Y, Laciak AR, Uggowitzer KA, Obiero JM, Freeman-Gallant G, Natarajan H, Green S, Pirayesh E, Lai YT, Himansu S, Carfi A, Hu LT, Mantis N, Plante O, Dold C. Monovalent and multivalent OspA mRNA-LNP vaccines elicit functional antibodies and protect against Borrelia burgdorferi in mice. NPJ Vaccines. 2026 May 5. doi: 10.1038/s41541-026-01451-7. Online ahead of print. |
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| Experimental |
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169. |
|
| mRNA-1982: Dose 3 | Experimental | Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169. |
|
| Placebo | Placebo Comparator | Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169. |
|
|
| mRNA-1982 | Biological | Dispersion delivered IM |
|
|
| Placebo | Biological | Solution delivered IM |
|
| Days 29, 85, and 197 |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Encore Research Group-Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| University Clinical Research-DeLand, LLC d/b/a Accel Research Sites | Lake Mary | Florida | 32746 | United States |
| Clinical Research Atlanta, headlands LLC | Stockbridge | Georgia | 30281 | United States |
| Johnson County Clin-Trials, Inc. (JCCT) | Lenexa | Kansas | 66219 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| Advanced Primary and Geriatric Care | Rockville | Maryland | 20850 | United States |
| DM Clinical Research - Brookline | Brookline | Massachusetts | 02445 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Meridian Clinical Research - Omaha | Omaha | Nebraska | 68134 | United States |
| ActivMed Research LLC | Newington | New Hampshire | 03801 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Hatboro Medical Associates/CCT Research | Hatboro | Pennsylvania | 19040 | United States |
| Velocity Clinical Research Providence | Providence | Rhode Island | 02886 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 23, 2026 | 8 | ||
| Jul 6, 2026 |
| 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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