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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-30
SponsorModernaTX, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mRNA-1189

    Biological/Vaccine

    Sterile liquid for injection

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: mRNA-1189 Dose Level 1 (ID)Experimental treatment 1 intervention
Group B: mRNA-1189 Dose Level 2 (ID)Experimental treatment 1 intervention
Group C: mRNA-1189 Dose Level 1 (IM)Experimental treatment 1 intervention
Group D: mRNA-1189 Dose Level 2 (IM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Time frame
Up to Day 64 (7-day follow-up after vaccination)
2

Number of Participants with Unsolicited Adverse Events (AEs)

Time frame
Up to Day 85 (28-day follow-up after vaccination)
3

Number of Participants with Medically Attended Adverse Events (MAAEs)

Time frame
Day 1 up to Day 225
4

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)

Time frame
Day 1 to end of study (EOS) (Day 225)

Secondary outcomes

1

Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)

Time frame
Days 1 and 85
2

Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb

Time frame
Day 85
3

Number of Participants With Seroconversion of Antigen-Specific bAbs

Time frame
Day 85

Other outcomes

Sponsors and contacts

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