Recruiting
Phase 1

mRNA-1469

Sponsor:

Moderna

Code:

NCT07737717

Conditions

Ebola-Bundibugyo Virus Disease (Ebola-BDBV)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

mRNA-1469

Placebo

Study Details

Brief summary:

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

Conditions

Ebola-Bundibugyo Virus Disease (Ebola-BDBV)

Study ID

NCT07737717

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: mRNA-1469 Dose Level 1

Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.

placebo comparator: Placebo Matching Dose Level 1

Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.

experimental: mRNA-1469 Dose Level 2

Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.

placebo comparator: Placebo Matching Dose Level 2

Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.

experimental: mRNA-1469 Dose Level 3

Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.

placebo comparator: Placebo Matching Dose Level 3

Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.

Interventions

mRNA-1469

Sterile liquid for injection

Placebo

Sterile liquid for injection

Primary outcome measure

  • 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) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Moderna WeCareTeam

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

Locations

Colchester Research Group

Recruiting

Truro, Nova Scotia, Canada, B2N 1L2

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Ebola-Bundibugyo Virus Disease (Ebola-BDBV)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-08-11.