The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
30 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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