A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults

Moderna

Status and phase: Enrolling; Phase 2; 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, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.

Enrollment: 842 estimated patients

Sex: All

Ages: 10 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 baseline EBV-seronegative adolescents from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).

Part C:

Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

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

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842 participants in 13 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

Part C: 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 C: 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 C: 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 C: 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