The trial is taking place at:
V

Victoria Clinical Research Group | Victoria, TX

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A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and 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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05164094
mRNA-1189-P101

Details and patient eligibility

About

The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults and the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old EBV-seronegative healthy adolescents.

Enrollment

422 estimated patients

Sex

All

Ages

12 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

* According to the assessment of the investigator, is in good general health and can comply with study procedures. Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0). Part B: Healthy adolescent from 12 to \<18 years of age at the time of consent (Screening Visit, Day 0). EBV - seronegative as determined by serology at screening.

Exclusion criteria

* Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit. * Has 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). * Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement. * Has a history of myocarditis, and/or pericarditis. * Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

422 participants in 9 patient groups, including a placebo group

Part A: mRNA-1189 Dose Level 2
Experimental group
Description:
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part A: mRNA-1189 Dose Level 3
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part A: mRNA-1189 Dose Level 4
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part A: Placebo
Placebo Comparator group
Description:
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Treatment:
Biological: Placebo
Part B: mRNA-1189 Dose Level 1
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 2
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 3
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 4
Experimental group
Description:
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Treatment:
Biological: mRNA-1189
Part B: Placebo
Placebo Comparator group
Description:
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Treatment:
Biological: Placebo

Trial contacts and locations

65

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Central trial contact

Moderna Clinical Trials Support Center

Data sourced from clinicaltrials.gov

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