mRNA Vaccines for Lyme Disease

No longer recruiting at 24 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins

Disqualifiers: Chronic Lyme disease, Myocarditis, others

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new mRNA vaccines to determine their safety and effectiveness in helping the body combat Lyme disease, which spreads through tick bites. Participants will receive either one of the two vaccines or a placebo (a shot with no active ingredients) to compare results. The study seeks healthy adults who have not been vaccinated for Lyme disease and have not had the disease recently. Those who have not had a tick bite in the last month and are in good health might be suitable for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants the chance to contribute to groundbreaking Lyme disease prevention efforts.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants or certain immune therapies, you may need to stop them before joining the study.

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

Research shows that the mRNA-1975 vaccine is generally safe. Earlier studies found it mostly caused mild to moderate side effects, which did not last long. Most children in these studies developed protective antibodies, proteins that help fight infections, after receiving the vaccine.

The mRNA-1982 vaccine has also undergone safety studies. It is similar to the mRNA vaccines used for COVID-19, which have been administered to many people. This background suggests it is likely safe, although specific details about side effects for mRNA-1982 are not provided in the sources.

Since these vaccines are in early-stage trials, researchers continue to closely monitor them for safety. Participants should know that understanding of side effects is still growing, but early results appear promising. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about mRNA-1975 and mRNA-1982 vaccines for Lyme disease because they use cutting-edge mRNA technology, which is different from the traditional antibiotic treatments and tick prevention methods currently available. Unlike existing options, these vaccines aim to prevent Lyme disease by teaching the immune system to recognize and fight the bacteria before infection takes hold. This innovative approach could offer a proactive solution, potentially reducing the incidence of Lyme disease rather than just treating it after infection has occurred.

What evidence suggests that this trial's treatments could be effective for Lyme disease?

Research has shown that mRNA vaccines, such as mRNA-1975 and mRNA-1982, are promising in creating strong defenses against infections. In this trial, participants will receive either the mRNA-1975 or mRNA-1982 vaccine, or a placebo. These vaccines help the body learn to recognize and fight Lyme disease bacteria. Early studies suggest that mRNA vaccines can effectively trigger immune responses, potentially preventing Lyme disease. The mRNA-1975 vaccine targets multiple strains, offering broad protection. In contrast, mRNA-1982 focuses on a single strain, which might still be effective due to its specific approach. While more information is needed, these vaccines use the same mRNA technology as the successful COVID-19 vaccines, indicating potential effectiveness. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-70 with a BMI of 18-39 kg/m2 can join this Lyme disease vaccine trial. Women must not be pregnant, use reliable contraception, or abstain from pregnancy-causing activities. Excluded are those who've had recent immunosuppressants, immune therapies, Lyme treatment/vaccination, tick bites within 4 weeks, skin conditions affecting assessments, or severe vaccine reactions.

Inclusion Criteria

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

Exclusion Criteria

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

I have chronic symptoms related to Lyme disease or an active Lyme infection.

I have been treated for Lyme disease in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intramuscular injections of either mRNA-1975 or mRNA-1982 vaccine or placebo on Days 1, 57, and 169

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after the final dose

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1975
• mRNA-1982
• Placebo

Trial Overview The study is testing the safety and body's response to two experimental vaccines against Lyme disease: heptavalent mRNA-1975 and monovalent mRNA-1982 compared to a placebo. Participants will receive injections and their health responses will be monitored.

How Is the Trial Designed?

Group I: mRNA-1982: Dose 3 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.

Group II: mRNA-1982: Dose 2 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.

Group III: mRNA-1982: Dose 1 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.

Group IV: mRNA-1975: Dose 4 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.

Group V: mRNA-1975: Dose 3 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.

Group VI: mRNA-1975: Dose 2 Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.

Group VII: mRNA-1975: Dose 1 Experimental Treatment 1 Intervention

Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.

Group VIII: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.

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

ModernaTX, Inc.

Chief Executive Officer since 2011

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

Published Research Related to This Trial

The only FDA-approved Lyme disease vaccine, based on the OspA protein, was effective in generating immunity against the disease but was withdrawn from the market in 2002 due to the need for booster doses and issues with false positive test results.

New clinical trials are currently underway for a multivalent OspA vaccine aimed at providing better protection against Lyme disease in both the United States and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief history of OspA vaccines including their impact on diagnostic testing for Lyme disease. Wormser, GP.[2022]

The adjuvanted recombinant vaccine LYMErix has been shown to be 76% effective in preventing Lyme disease in a clinical trial involving over 10,000 adults, following a three-dose schedule.

The vaccine is safe, with only mild to moderate transient side effects reported, and it induces protective antibody levels in nearly all children aged 2-14 years, making it a reliable option for Lyme disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention of Lyme disease with vaccine. Poland, GA., Jacobson, RM.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05975099?term=heptavalent&viewType=Table&rank=7

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 ...

2. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1975%2F1982-P101

A Clinical Trial of a Lyme Disease Vaccine for Adults The Canopy Trial will look at the safety and immune response of mRNA-based investigational vaccines aimed at preventing Lyme disease.

3. s29.q4cdn.com s29.q4cdn.com/435878511/files/doc_downloads/program_detail/2023/09/Lyme-09-13-23.pdf

Lyme vaccines (mRNA-1975 & mRNA-1982) Patients can develop rash, fever, headaches, fatigue, joint pain swelling, stiffness and headaches. Some of these symptoms can.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11564800/

Progress and prospects of mRNA-based drugs in pre-clinical ... Their findings revealed that the mRNA vaccine markedly elicited robust T-cell-mediated immune responses in tumor-bearing mice, leading to a ...

5. withpower.com withpower.com/trial/phase-2-lyme-disease-6-2023-88a3b

mRNA Vaccines for Lyme Disease · Info for Participants The adjuvanted recombinant vaccine LYMErix has been shown to be 76% effective in preventing Lyme disease in a clinical trial involving over 10,000 adults, ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-safety-and-immunogenicity-of-mrna-1975-and-mrna-1982-against-lyme-disease-in

A Study to Evaluate the Safety and Immunogenicity of mRNA ... The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05975099/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 Study to Evaluate the Safety and Immunogenicity ... 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 ...