A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants 18 to 65 Years of Age
1 other identifier
interventional
84
1 country
3
Brief Summary
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
July 30, 2026
July 1, 2026
1.2 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Up to Day 169 (6 months follow-up after injection)
Number of Participants with Serious Adverse Events (SAEs), Any AEs Leading to Discontinuation From Study Participation and/or Study Vaccination, and AEs of Special Interest (AESIs)
Up to End of Study (EOS) (Day 337)
Secondary Outcomes (1)
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
At Day 29 and Up to Day 337
Study Arms (6)
mRNA-1469 Dose Level 1
EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Placebo Matching Dose Level 1
PLACEBO COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
mRNA-1469 Dose Level 2
EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Placebo Matching Dose Level 2
PLACEBO COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
mRNA-1469 Dose Level 3
EXPERIMENTALParticipants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Placebo Matching Dose Level 3
PLACEBO COMPARATORParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Body mass index within the range 18.5 to 39 kg/m2 (inclusive).
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
You may not qualify if:
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- History of participation in a prior vaccine study for pathogens causing Ebola virus disease.
- History of confirmed or suspected filovirus exposure or infection or travel to an impacted area within 1 month prior to the Screening Visit (e.g. Ebola Zaire, Sudan, BDBV, and Marburg).
- Other conditions that in the Investigator's opinion could interfere with interpretation of study results or limit the participant's participation in the study.
- Acutely ill or febrile (temperature ≥38.0℃ \[100.4°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
- Abnormal screening clinical laboratory values \>Grade 1 for total white blood cell count, hemoglobin, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, total bilirubin, or platelets.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (3)
Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K6R8, Canada
Colchester Research Group
Truro, Nova Scotia, B2N 1L2, Canada
Centricity Research Toronto LMC Multispecialty
Toronto, Ontario, M4G 3E8, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start
July 31, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
July 30, 2026
Record last verified: 2026-07