Lyme DiseasePhase 1/2NCT05975099
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
A Phase 1/2 study testing mRNA-1975 and mRNA-1982 in people with Lyme Disease, run by ModernaTX, Inc. at 20 sites in United States.
Trial 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. 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-1975 and mRNA-1982
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 807 participants
- Where
- 20 sitesUnited States
- Study dates
- 26 Jul 2023to 30 May 2025
- Phase
- Phase 1/2
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
- Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit.
- Participants of nonchildbearing potential may be enrolled in the study.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy during the study intervention period, and agreement to continue adequate contraception or abstinence through 3 months following last study injection.
Who cannot join
- 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.
- Had previous vaccination against Lyme disease or participated in the past in any vaccine study for Lyme disease.
- Had a tick bite within 4 weeks prior to the study injection visit.
- Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas).
- Received systemic immunosuppressants for >14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
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- History of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history.
- History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study injection.
- Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
DM Clinical Research - Brookline
Brookline, Massachusetts, 02445
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Centennial Medical Group
Columbia, Maryland, 21045
Benchmark Research
Fort Worth, Texas, 76135
Hatboro Medical Associates/CCT Research
Hatboro, Pennsylvania, 19040
Encore Research Group-Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
Lake Mary, Florida, 32746
Johnson County Clin-Trials, Inc. (JCCT)
Lenexa, Kansas, 66219
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
ActivMed Research LLC
Newington, New Hampshire, 03801
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Meridian Clinical Research - Omaha
Omaha, Nebraska, 68134
Velocity Clinical Research Providence
Providence, Rhode Island, 02886
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Advanced Primary and Geriatric Care
Rockville, Maryland, 20850
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Clinical Research Atlanta, headlands LLC
Stockbridge, Georgia, 30281
DM Clinical Research
Tomball, Texas, 77375
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
About this study
Official title: A Phase 1/2, Randomized, Observer-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Immunogenicity of Heptavalent mRNA-1975 (SR1-7) and Monovalent mRNA-1982 (SR1) in Parallel Against Lyme Disease in Healthy Participants 18 Through 70 Years of Age
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.
- Conditions
- Lyme Disease
- Being tested
- mRNA-1975, mRNA-1982, Placebo
- Keywords
- mRNA-1975, mRNA-1982, Vaccine, Lyme Disease Vaccine, Messenger RNA, Moderna
- 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-1975Biological
Also called SR1-7
Dispersion delivered IM
mRNA-1982Biological
Also called SR1
Dispersion delivered IM
PlaceboBiological
Solution delivered IM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: mRNA-1975 |
| 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. Receives: Biological: mRNA-1975 |
| 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. Receives: Biological: mRNA-1975 |
| 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. Receives: Biological: mRNA-1975 |
| 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. Receives: Biological: mRNA-1982 |
| mRNA-1982: Dose 2 | Experimental | Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169. Receives: Biological: mRNA-1982 |
| 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. Receives: Biological: mRNA-1982 |
| Placebo | Placebo comparator | Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Measured: Up to 7 days after Day 169 injection
Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Measured: Day 1 up to Month 18
Secondary outcomes (14)
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values reported greater than upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 41.4 nanograms (ng)/milliliter (mL) and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% confidence interval (CI) for GM value was calculated based on the t-distribution of the log-transformed values , then back transformed to the original scale for presentation.
Measured: Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85, and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 1, 29, 85 and 197
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 41.4 ng/mL and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Measured: Days 29, 85 and 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start26 Jul 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 807 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
- NCT05975099
- Sponsor's protocol ID
- mRNA-1975/1982-P101
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2023
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 42086599