A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants

August 7, 2026 updated by: ModernaTX, Inc.

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

The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K6R8
        • Not yet recruiting
        • Canadian Center for Vaccinology
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Recruiting
        • Colchester Research Group
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • Not yet recruiting
        • Centricity Research Toronto LMC Multispecialty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-1469 Dose Level 1
Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Biological: mRNA-1469
Sterile liquid for injection
Placebo Comparator: Placebo Matching Dose Level 1
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
Biological: Placebo
Sterile liquid for injection
Experimental: mRNA-1469 Dose Level 2
Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Biological: mRNA-1469
Sterile liquid for injection
Placebo Comparator: Placebo Matching Dose Level 2
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
Biological: Placebo
Sterile liquid for injection
Experimental: mRNA-1469 Dose Level 3
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Biological: mRNA-1469
Sterile liquid for injection
Placebo Comparator: Placebo Matching Dose Level 3
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Biological: Placebo
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 7 (the day of study intervention and 6 subsequent days)
Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (the day of study intervention and 27 subsequent days)
Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time Frame: Up to Day 169 (6 months follow-up after injection)
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)
Time Frame: Up to End of Study (EOS) (Day 337)
Up to End of Study (EOS) (Day 337)

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Time Frame: At Day 29 and Up to Day 337
At Day 29 and Up to Day 337

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mRNA-1469-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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