mRNA Vaccines for Lyme Disease

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

807 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two different vaccines for Lyme disease in healthy adults. One vaccine targets seven parts of the bacteria, and the other targets just one. The vaccines use mRNA to teach the immune system to recognize and fight the bacteria.

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.

What data supports the effectiveness of the mRNA-1975 and mRNA-1982 treatments for Lyme disease?

Research shows that mRNA vaccines, like those used for COVID-19, can be effective against Lyme disease. An mRNA vaccine targeting a protein from the Lyme disease bacteria showed strong immune responses and protection in mice, suggesting potential effectiveness in humans. ^{1 2 3 4 5}

Is the mRNA vaccine for Lyme disease safe for humans?

The mRNA vaccine for Lyme disease, similar to previous Lyme vaccines, has shown to be safe in clinical trials, with most side effects being mild or moderate, such as temporary pain at the injection site. ^{1 5 6 7 8}

How is the mRNA-1975 and mRNA-1982 treatment for Lyme disease different from other treatments?

The mRNA-1975 and mRNA-1982 treatments for Lyme disease are unique because they use mRNA technology, similar to COVID-19 vaccines, to teach the body to recognize and fight the bacteria causing Lyme disease. This approach is different from traditional vaccines and treatments, which often rely on protein subunits or antibiotics. ^{1 5 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of an mRNA-lipid nanoparticle vaccine against Lyme disease. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Artificial-infection protocols allow immunodetection of novel Borrelia burgdorferi antigens suitable as vaccine candidates against Lyme disease. [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

Resolution of experimental and tick-borne Borrelia burgdorferi infection in mice by passive, but not active immunization using recombinant OspC. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Cellular immune response in Lyme disease: the response to mitogens, live Borrelia burgdorferi, NK cell function and lymphocyte subsets. [2019]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Immunization in Lyme borreliosis--initial experience]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Adjuvanted Lyme disease vaccine: a review of its use in the management of Lyme disease. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The prevention of Lyme disease with vaccine. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of an OspA vaccine preparation for prevention of Lyme disease in New York State. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lyme Vaccine: A Matched Case-Control Study. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and immunological assessment of a candidate Lyme disease vaccine in healthy adults: antibody persistence and effect of a booster dose at month 12. [2019]