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mRNA-1195.1

Phase 1

Epstein-Barr Virus Infection | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: Sep 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment482
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05831111A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy ParticipantsPHASE1 ACTIVE NOT_RECRUITING 482 — — Apr 5, 2023Oct 7, 2026Sep 30, 202534 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 176 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 197 (28-day follow-up after vaccination)
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs)
Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
Secondary Endpoints
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
Days 1, 85, and 197
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb
Days 1, 85, and 197
Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs
Days 1, 85, and 197
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Part A: mRNA-1195.1 Dose Level 1EXPERIMENTALParticipants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Part A: mRNA-1195.2 Dose Level 1EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Part A: mRNA-1195.1 Dose Level 2EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Part A: mRNA-1195.2 Dose Level 2EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Part A: mRNA-1195.1 Dose Level 3EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Part A: mRNA-1195.2 Dose Level 3EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Part A: mRNA-1195.1 Dose Level 4EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Part A: mRNA-1195.2 Dose Level 4EXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Part A: mRNA-1189ACTIVE_COMPARATORParticipants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Part B: PlaceboPLACEBO_COMPARATORParticipants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Part B: mRNA-1195 Low DoseEXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
Part B: mRNA-1195 Middle DoseEXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
Part B: mRNA-1195 High DoseEXPERIMENTALParticipants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
Interventions
NameTypeDescription
mRNA-1195.1BIOLOGICALSterile liquid for injection
mRNA-1195.2BIOLOGICALSterile liquid for injection
mRNA-1189BIOLOGICALSterile liquid for injection
PlaceboBIOLOGICAL0.9% sodium chloride (normal saline) injection
mRNA-1195BIOLOGICALSterile liquid for injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites34

Key Inclusion Criteria: * For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening. * According to the assessment of the Investigator, is in good general health and can comply with study procedures. * For participants of childbear...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05831111primaryCompletionDate: changed
LOWMay 24, 2026NCT05831111studyFirstPostDate: changed