mRNA-1982 Vaccine for Lyme Disease

Not currently recruiting at 7 trial locations
MW
Overseen ByModerna WeCare Team
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ModernaTX, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA vaccine designed to prevent Lyme disease, a tick-borne illness that can cause flu-like symptoms and joint pain. The study aims to determine the optimal dose, evaluate the vaccine's effectiveness, and assess its safety. Participants will receive either the mRNA vaccine or a placebo via injection. Ideal candidates are healthy adults who have not recently undergone Lyme disease treatment or received any Lyme disease vaccines. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

An earlier study found the mRNA-1982 vaccine for Lyme disease to be generally safe. The research showed no serious side effects, with no major health issues reported. Some participants experienced mild symptoms such as rash, fever, headaches, tiredness, and joint pain. These common vaccine reactions typically resolve on their own. Now in Phase 2 trials, this treatment has already passed at least one human study, indicating it is well-tolerated so far.12345

Why do researchers think this study treatment might be promising for Lyme disease?

Unlike traditional vaccines for Lyme disease, which often use inactivated or attenuated bacteria, the mRNA-1982 vaccine harnesses the power of mRNA technology. This means it teaches the body to produce a protein from the Lyme-causing bacteria, prompting an immune response without using the actual bacteria. Researchers are excited because this approach can potentially offer a more precise and adaptable response, reducing the risk of side effects and potentially improving efficacy. Additionally, the mRNA platform allows for quicker updates to the vaccine if the pathogen changes over time.

What evidence suggests that the mRNA-1982 vaccine could be an effective treatment for Lyme disease?

Research has shown that past Lyme disease vaccines, which targeted specific parts of the bacteria, provided strong protection by triggering the body's defense system. Early results from studies on the mRNA-1982 vaccine, currently tested in this trial, indicate it can safely activate the immune system. Other studies have demonstrated that vaccines targeting six different strains of Lyme disease have been over 70% effective in preventing the illness. Initial signs also indicate that mRNA-based vaccines can boost immune protection without causing serious side effects. These findings suggest that mRNA-1982 could effectively prevent Lyme disease.12356

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 70 who are considered in good health by a doctor. Participants must agree to use contraception as required by local laws.

Inclusion Criteria

* 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-finding Phase

Participants will receive mRNA-1982 or placebo as an intramuscular injection

4 weeks

Booster Phase

Participants will receive mRNA-1982 (as a booster) or placebo as an intramuscular injection

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1982

Trial Overview

The study is testing an experimental mRNA vaccine called mRNA-1982, designed to prevent Lyme disease. Some participants will get the vaccine and others will receive a placebo (inactive shot) for comparison.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose-finding PhaseExperimental Treatment2 Interventions
Group II: Booster PhaseExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

P-1485. Safety and Immunogenicity of mRNA-1982 and ... - PMC

Previously developed Lyme disease vaccines based on Borrelia OspA antigens elicited antibody responses that correlated with protection; however, ...

P-1485. Safety and Immunogenicity of mRNA-1982 and ...

Safety and Immunogenicity of mRNA-1982 and mRNA-1975, mRNA Vaccine Candidates for Prevention of Lyme Disease in Healthy Adults: Interim Results ...

NCT05975099 | A Study to Evaluate the Safety and ...

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 ...

Lyme disease vaccine shows over 70% efficacy in phase 3 ...

An experimental six-strain Lyme vaccine has demonstrated more than 70% efficacy in preventing Lyme disease in people aged five years and older, ...

Safety and Immunogenicity of mRNA-1982 and mRNA-1975 ...

Safety and Immunogenicity of mRNA-1982 and mRNA-1975, mRNA Vaccine Candidates for Prevention of Lyme Disease in Healthy Adults: Interim Results ...

A Study to Evaluate the Safety and Immunogenicity of mRNA ...

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.