Lyme DiseasePhase 2NCT07561294
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)
A Phase 2 study testing mRNA-1982 in people with Lyme Disease, run by ModernaTX, Inc. at 8 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- mRNA-1982
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 8 sitesCanada
- Study dates
- 29 Apr 2026to 9 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
- Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.
- Received treatment for Lyme disease within the prior 3 months.
- Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.
- Had a tick bite within 4 weeks prior to Day 1.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Diex Recherche Inc. - Division Joliette
Joliette, Quebec, J6E 6A9
Diex Recherche Inc. - Division Quebec
Québec, G1V 4T3
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3
Diex Recherche Inc. - Division Sherbrooke
Sherbrooke, Quebec, J1L 0H8
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2
Dr. Anil K. Gupta Medicine Professional Corporation Inc.
Toronto, Ontario, M9V 4B4
Colchester Research Group
Truro, Nova Scotia, B2N 1L2
Diex Recherche Inc. - Division Victoriaville
Victoriaville, Quebec, G6P 3Z8
About this study
Official title: A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)
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.
- Conditions
- Lyme Disease
- Being tested
- mRNA-1982, Placebo
- Keywords
- Moderna, mRNA-1982, Messenger RNA, Safety, Vaccines
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1982Biological
Suspension for injection
PlaceboBiological
Suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| Dose-finding Phase | Experimental | Participants will receive mRNA-1982 or placebo as an intramuscular injection. Receives: Biological: mRNA-1982; Biological: Placebo |
| Booster Phase | Experimental | Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection. Receives: Biological: mRNA-1982; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions
Measured: Day 1 up to Day 7 (7 days post-injection)
Both Phases: Number of Participants with Unsolicited Adverse Events
Measured: 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
Measured: Day 1 up to Month 21 (End of study)
Secondary outcomes (4)
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)
Measured: Days 1, 113, 197, 265, and 349
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab
Measured: Days 113, 197, 265, and 349
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab
Measured: Days 1, 29, and 181 of Booster Phase
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab
Measured: Days 29 and 181 of Booster Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start29 Apr 2026
- Primary completion9 Nov 2028 (estimated)
- Study completion9 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561294
- Sponsor's protocol ID
- mRNA-1982-P201
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)
- ClinicalTrials.gov ID
- NCT07561294
- Acronym / sponsor ID
- mRNA-1982-P201
- Conditions
- Lyme Disease
- Keywords
- Moderna, mRNA-1982, Messenger RNA, Safety, Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 366 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 9 Nov 2028 (estimated)
- Study completion
- 9 Nov 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-finding Phase | Experimental | Biological: mRNA-1982, Biological: PlaceboParticipants will receive mRNA-1982 or placebo as an intramuscular injection. |
| Booster Phase | Experimental | Biological: mRNA-1982, Biological: PlaceboParticipants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening.
- Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (6 listed)
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
- Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician.
- Received treatment for Lyme disease within the prior 3 months.
- Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.
- Had a tick bite within 4 weeks prior to Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1982Suspension for injection | Biological | Booster Phase, Dose-finding Phase |
| PlaceboSuspension for injection | Biological | Booster Phase, Dose-finding Phase |
Primary outcome
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions
Time frame: Day 1 up to Day 7 (7 days post-injection)
Both Phases: Number of Participants with Unsolicited Adverse Events
Time frame: 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
Time frame: Day 1 up to Month 21 (End of study)
4 secondary outcomes
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)
Time frame: Days 1, 113, 197, 265, and 349
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 113, 197, 265, and 349
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 1, 29, and 181 of Booster Phase
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab
Time frame: Days 29 and 181 of Booster Phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-1982 in people with Lyme Disease, run by ModernaTX, Inc. at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions (time frame: Day 1 up to Day 7 (7 days post-injection)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.