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
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
807actual
Sites
20
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-26 | actual | When the study began enrolling |
| Primary completion | 2025-05-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-30 | actual | The whole study's end, after follow-up |
| First posted | 2023-08-03 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lyme Disease
Interventions
- Biological: mRNA-1975 — also filed as SR1-7
- Biological: mRNA-1982 — also filed as SR1
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
measured Up to 7 days after Day 1 injection
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
measured Up to 7 days after Day 57 injection
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
measured Up to 7 days after Day 169 injection
Number of Participants With Unsolicited AEs
measured Up to 28 days post any injection
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
measured Day 1 up to Month 18
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-04-08 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-11-14 · 1.2 MB · SAP_001.pdf
Publications
- PMID 42086599 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · MRNA's whole pipeline · Catalyst calendar · Every registered study · What changed