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

Moderna

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Lyme Disease

Treatments: Biological: Placebo; Biological: mRNA-1975; Biological: mRNA-1982

Study type: Interventional

Funder types: Industry

Identifiers

NCT05975099

mRNA-1975/1982-P101

Details and patient eligibility

About

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 healthy adult participants.

Enrollment: 807 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

• 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.
• Had previous vaccination against Lyme disease or participated in the past in any vaccine study for Lyme disease.
• Had a tick bite within 4 weeks prior to the study injection visit.
• Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas).
• Received systemic immunosuppressants for >14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
• History of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history.
• 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.
• Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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807 participants in 8 patient groups, including a placebo group

mRNA-1975: Dose 1

Experimental group

Description:

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

Treatment:

Biological: mRNA-1975

mRNA-1975: Dose 2

Experimental group

Description:

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

Treatment:

Biological: mRNA-1975

mRNA-1975: Dose 3

Experimental group

Description:

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

Treatment:

Biological: mRNA-1975

mRNA-1975: Dose 4

Experimental group

Description:

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

Treatment:

Biological: mRNA-1975

mRNA-1982: Dose 1

Experimental group

Description:

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

Treatment:

Biological: mRNA-1982

mRNA-1982: Dose 2

Experimental group

Description:

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

Treatment:

Biological: mRNA-1982

mRNA-1982: Dose 3

Experimental group

Description:

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

Treatment:

Biological: mRNA-1982

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo