A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)

ConditionLyme Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorModernaTX, Inc.

About this trial

This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.

Eligibility criteria

Qualifiers

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.

Disqualifiers

History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.

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.

Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease.

Trial design

Treatments tested in this trial

  • mRNA-1982
  • Placebo

Treatment groups

350 Participants
are divided into 2 treatment groups

Locations

8
Colchester Research GroupB2N 1L2, TruroNova Scotia, Canada
Bluewater Clinical Research Group Inc.N7T 4X3, SarniaOntario, Canada
Stouffville Medical Research Institute Inc.L4A 1H2, StouffvilleOntario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation Inc.M9V 4B4, TorontoOntario, Canada

Sponsors and collaborators

ModernaTX, Inc.

Lead sponsor