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Recruiting Phase 1 NCT07478952

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

Phase 1 – testing safety in a small group of people
Conditions: Epstein-Barr Virus

Sponsor: ModernaTX, Inc.

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Overview
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Who can participate
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.
Locations 1
Australia (1)
Nucleus Network
Melbourne , Victoria
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
30 Years
Healthy volunteers
No
Start date
17.03.2026
Completion date
15.05.2027
Registry ID
NCT07478952
Source
anzctr
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