A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants

October 30, 2026 updated by: ModernaTX, Inc.

A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants 18 to 55 Years of Age

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

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

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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 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 filovirus (Ebola Zaire, Sudan, Bundibugyo, and Marburg) vaccine study.
  • History of confirmed or suspected filovirus infection.
  • 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-1519 Dose Level 1 Single Dose

Participants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1
Biological: mRNA-1519

Sterile liquid for injection
Placebo Comparator: Placebo Matching Dose Level 1 Single Dose

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

Sterile liquid for injection
Experimental: mRNA-1519 Dose Level 1 Two-Dose

Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57
Biological: mRNA-1519

Sterile liquid for injection
Placebo Comparator: Placebo Matching Dose Level 1 Two-Dose

Participants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57
Biological: Placebo

Sterile liquid for injection
Experimental: mRNA-1519 Dose Level 2

Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1
Biological: mRNA-1519

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-1519 Dose Level 3

Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1
Biological: mRNA-1519

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 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)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Through 7 days after each study intervention
Through 7 days after each study intervention
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Through 28 days after each study intervention
Through 28 days after each study intervention
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time Frame: From Day 1 to 6 months after the last study intervention
From Day 1 to 6 months after the last study intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Titer of Marburg Virus (MARV)-Specific Binding Antibodies (bAbs)
Time Frame: At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
Geometric Mean Titer of Marburg Virus (MARV)-Specific Neutralizing Antibodies (nAbs)
Time Frame: Throughout the study (Up to EOS/Day 337)
Throughout the study (Up to EOS/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 (Estimated)

November 2, 2026

Primary Completion (Estimated)

April 14, 2028

Study Completion (Estimated)

April 14, 2028

Study Registration Dates

First Submitted

October 30, 2026

First Submitted That Met QC Criteria

October 30, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1519-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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