Epstein-Barr Virus
Conditions
Keywords
Epstein-Barr Virus (EBV)
Brief summary
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Interventions
BIOLOGICALmRNA-1189
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 64 (7-day follow-up after vaccination) |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 85 (28-day follow-up after vaccination) |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | Day 1 up to Day 225 |
| Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs) | Day 1 to end of study (EOS) (Day 225) |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb) | Days 1 and 85 |
| Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb | Day 85 |
| Number of Participants With Seroconversion of Antigen-Specific bAbs | Day 85 |
Countries
Australia
Contacts
CONTACTModerna WeCare Team
Outcome results
None listed