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

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Moderna

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Lyme Disease

Treatments

Biological: mRNA-1975
Biological: Placebo
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

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

Trial contacts and locations

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Central trial contact

Moderna Clinical Trials Support Center

Data sourced from clinicaltrials.gov

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