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

Moderna

Status and phase: Active, not recruiting; Phase 1

Conditions: Ebola-Bundibugyo Virus Disease (Ebola-BDBV)

Treatments: Biological: Placebo; Biological: mRNA-1469

Study type: Interventional

Funder types: Industry

Identifiers

NCT07737717

mRNA-1469-P101

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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84 participants in 6 patient groups, including a placebo group

mRNA-1469 Dose Level 1

Experimental group

Description:

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

Treatment:

Biological: mRNA-1469

Placebo Matching Dose Level 1

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

mRNA-1469 Dose Level 2

Experimental group

Description:

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

Treatment:

Biological: mRNA-1469

Placebo Matching Dose Level 2

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

mRNA-1469 Dose Level 3

Experimental group

Description:

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

Treatment:

Biological: mRNA-1469

Placebo Matching Dose Level 3

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo