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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • mRNA-1982

    Biological/Vaccine

    Suspension for injection

  • Placebo

    Biological/Vaccine

    Suspension for injection

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Dose-finding PhaseExperimental treatment 2 interventions
Group B: Booster PhaseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions

Time frame
Day 1 up to Day 7 (7 days post-injection)
2

Both Phases: Number of Participants with Unsolicited Adverse Events

Time frame
Day 1 up to Day 28 (28 days post-injection)
3

Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation

Time frame
Day 1 up to Month 21 (End of study)

Secondary outcomes

1

Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)

Time frame
Days 1, 113, 197, 265, and 349
2

Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab

Time frame
Days 113, 197, 265, and 349
3

Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab

Time frame
Days 1, 29, and 181 of Booster Phase
4

Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab

Time frame
Days 29 and 181 of Booster Phase

Other outcomes

Sponsors and contacts

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