NCT07478952

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Mar 2026May 2027

First Submitted

Initial submission to the registry

March 13, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 13, 2026

Last Update Submit

March 20, 2026

Conditions

Epstein-Barr Virus

Keywords

Epstein-Barr Virus (EBV)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (4)

mRNA-1189 Dose Level 1 (ID)

EXPERIMENTAL

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

Biological: mRNA-1189

mRNA-1189 Dose Level 2 (ID)

EXPERIMENTAL

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

Biological: mRNA-1189

mRNA-1189 Dose Level 1 (IM)

EXPERIMENTAL

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

Biological: mRNA-1189

mRNA-1189 Dose Level 2 (IM)

EXPERIMENTAL

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

Biological: mRNA-1189

Interventions

mRNA-1189BIOLOGICAL

Sterile liquid for injection

mRNA-1189 Dose Level 1 (ID)mRNA-1189 Dose Level 1 (IM)mRNA-1189 Dose Level 2 (ID)mRNA-1189 Dose Level 2 (IM)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nucleus Network

Melbourne, Victoria, VIC 3004, Australia

RECRUITING

Doherty Clinical Trials

Melbourne, Victoria, VIC 3149, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Central Study Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762WeCareClinicalTrials@modernatx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

March 17, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

AU(2)