A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age
Phase 1/2
Completed
NCT05975099
| Condition | Lyme Disease |
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| Phase | Phase 1/2 |
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| Sponsor | ModernaTX, Inc. |
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| Status | Completed |
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| Enrollment | 807 participants |
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| Interventions | mRNA-1975, mRNA-1982 |
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| Start date | Jul 26, 2023 |
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| Completion date | May 30, 2025 |
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| Results posted | Jul 30, 2026 |
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Summary
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.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Up to 7 days after Day 1 injection · Participants
| mRNA-1975 Dose Level 1 | 70 Participants |
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| mRNA-1975 Dose Level 2 | 80 Participants |
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| mRNA-1975 Dose Level 3 | 82 Participants |
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| mRNA-1975 Dose Level 4 | 91 Participants |
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| mRNA-1982 Dose Level 1 | 64 Participants |
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| mRNA-1982 Dose Level 2 | 77 Participants |
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
Up to 7 days after Day 57 injection · Participants
| mRNA-1975 Dose Level 1 | 79 Participants |
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| mRNA-1975 Dose Level 2 | 80 Participants |
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| mRNA-1975 Dose Level 3 | 90 Participants |
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| mRNA-1975 Dose Level 4 | 96 Participants |
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| mRNA-1982 Dose Level 1 | 70 Participants |
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| mRNA-1982 Dose Level 2 | 82 Participants |
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
Up to 7 days after Day 169 injection · Participants
| mRNA-1975 Dose Level 1 | 81 Participants |
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| mRNA-1975 Dose Level 2 | 87 Participants |
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| mRNA-1975 Dose Level 3 | 81 Participants |
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| mRNA-1975 Dose Level 4 | 92 Participants |
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| mRNA-1982 Dose Level 1 | 76 Participants |
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| mRNA-1982 Dose Level 2 | 82 Participants |
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Open in BENITIONS
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