A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults

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Moderna

Status and phase

Active, not recruiting
Phase 1

Conditions

Epstein-Barr Virus Infection

Treatments

Biological: mRNA-1189
Biological: Placebo
Biological: mRNA-1195.2
Biological: mRNA-1195.1

Study type

Interventional

Funder types

Industry

Identifiers

NCT05831111
mRNA-1195-P101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy adults (18 to 55 years of age).

Full description

There will be 2 sequential parts to the study: Participants will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening. Part B will enroll only those participants who are EBV-seronegative at Screening.

Enrollment

354 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus at Screening.
  • According to the assessment of the Investigator, is in good general health and can comply with study procedures.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 3 months following vaccine administration.

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator).
  • Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
  • History of myocarditis, pericarditis, or myopericarditis.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed.
  • Participant has received or plans to receive any licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza or SARS-CoV-2 vaccines, which may be received more than 14 days before or after any study injection.
  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

354 participants in 15 patient groups, including a placebo group

Part A: mRNA-1195.1 Dose Level 1
Experimental group
Description:
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 1
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 2
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 2
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 3
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 3
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.2
Part A: mRNA-1195.1 Dose Level 4
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Part A: mRNA-1195.2 Dose Level 4
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.2
Part A: mRNA-1189
Active Comparator group
Description:
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part A: Placebo
Placebo Comparator group
Description:
Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.
Treatment:
Biological: Placebo
Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Biological: mRNA-1195.2
Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Biological: mRNA-1195.2
Part B: mRNA-1195.1 or mRNA-1195.2 High Dose
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1195.1
Biological: mRNA-1195.2
Part B: mRNA-1189
Active Comparator group
Description:
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part B: Placebo
Placebo Comparator group
Description:
Participants will receive IM injection of study drug-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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