A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age

Moderna

Status and phase: Enrolling; Phase 1

Conditions: Epstein-Barr Virus

Treatments: Biological: mRNA-1189

Study type: Interventional

Funder types: Industry

Identifiers

NCT07478952

mRNA-NEXT-001

Details and patient eligibility

About

The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy as determined by medical evaluation including medical history and physical examination.
• Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.

Exclusion criteria

• Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
• Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
• Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
• Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day 57.
• History of myocarditis, pericarditis, or myopericarditis prior to Day 1.
• Has previously received an investigational EBV vaccine.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

mRNA-1189 Dose Level 1 (ID)

Experimental group

Description:

Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.

Treatment:

Biological: mRNA-1189

mRNA-1189 Dose Level 2 (ID)

Experimental group

Description:

Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57.

Treatment:

Biological: mRNA-1189

mRNA-1189 Dose Level 1 (IM)

Experimental group

Description:

Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57.

Treatment:

Biological: mRNA-1189

mRNA-1189 Dose Level 2 (IM)

Experimental group

Description:

Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57.

Treatment:

Biological: mRNA-1189