What side effects are associated with this type of intervention?

The most common side effects of mRNA vaccines, such as those being studied for Lyme disease (mRNA-1975 and mRNA-1982), include pain at the injection site, headache, fatigue, muscle/joint pain, and fever. These reactions are generally mild to moderate and transient. Systemic reactions like fever and fatigue are more common after the second dose and in younger individuals. Serious adverse events are rare and typically not related to the vaccine.

What prior FDA approvals exist?

There is no specific information available regarding prior FDA approvals for mRNA vaccines for Lyme disease. Traditional treatments for Lyme disease typically involve antibiotics such as doxycycline, amoxicillin, or cefuroxime axetil. The mRNA-1975 and mRNA-1982 vaccines represent a novel approach, using messenger RNA to produce proteins that trigger an immune response against Lyme disease.

What other types of research exist?

One promising alternative is the use of recombinant outer surface proteins A (OspA) and B (OspB) of Borrelia burgdorferi, which have been investigated with adjuvants like QS-21 and aluminium hydroxide to enhance immunogenicity. Another potential approach involves the use of interleukin-6 (IL-6) to augment borreliacidal antibody production against OspC-expressing B. burgdorferi. These alternatives focus on different antigens and immune response mechanisms, offering potential new avenues for Lyme disease vaccination.

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Cancer Vaccine

mRNA Vaccines for Lyme Disease

Phase 1 & 2

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at the injection site, fatigue, headache or fever. More serious allergic reactions like anaphylaxis could occur but are rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1982: Dose 3Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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 4Experimental Treatment1 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 3Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lyme Disease include antibiotics and emerging mRNA vaccines. Antibiotics work by directly targeting and preventing the replication of Borrelia burgdorferi bacteria, aiding the immune system in clearing the infection. Emerging mRNA vaccines, such as mRNA-1975 and mRNA-1982, introduce messenger RNA sequences that instruct cells to produce proteins mimicking parts of the bacteria, triggering an immune response. This helps the body recognize and fight the bacteria if exposed in the future. Understanding these mechanisms is crucial for Lyme Disease patients as it emphasizes the importance of both immediate bacterial eradication and long-term immune preparedness.

Inflammatory myopathy occurring shortly after severe acute respiratory syndrome coronavirus 2 vaccination: two case reports.Vaccination with Messenger RNA: A Promising Alternative to DNA Vaccination.mRNA vaccines - a new era in vaccinology.