Marburg Virus Disease (MVD)Phase 1NCT07919210
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
A Phase 1 study testing mRNA-1519 in people with Marburg Virus Disease (MVD), run by ModernaTX, Inc. at 1 site in United Kingdom.
Trial summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Marburg Virus Disease (MVD)
- What is being tested?
- mRNA-1519
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2026to 14 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Marburg Virus Disease (MVD)
- Being tested
- mRNA-1519, Placebo
- Keywords
- Marburg Virus (MARV), Marburg Virus Disease (MVD), Filovirus, Moderna, Healthy Participants
- Medical subject headings
- Marburg Virus Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1519Biological
Sterile liquid for injection
PlaceboBiological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1519 Dose Level 1 Single Dose | Experimental | Participants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1 Receives: Biological: mRNA-1519 |
| Placebo Matching Dose Level 1 Single Dose | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1 Receives: Biological: Placebo |
| mRNA-1519 Dose Level 1 Two-Dose | Experimental | Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57 Receives: Biological: mRNA-1519 |
| Placebo Matching Dose Level 1 Two-Dose | Placebo comparator | Participants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57 Receives: Biological: Placebo |
| mRNA-1519 Dose Level 2 | Experimental | Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1 Receives: Biological: mRNA-1519 |
| Placebo Matching Dose Level 2 | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1 Receives: Biological: Placebo |
| mRNA-1519 Dose Level 3 | Experimental | Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1 Receives: Biological: mRNA-1519 |
| Placebo Matching Dose Level 3 | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Through 7 days after each study intervention
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Through 28 days after each study intervention
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: From Day 1 to 6 months after the last study intervention
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)
Measured: Up to End of Study (EOS) (Day 337)
Secondary outcomes (2)
Geometric Mean Titer of Marburg Virus (MARV)-Specific Binding Antibodies (bAbs)
Measured: 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)
Measured: Throughout the study (Up to EOS/Day 337)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion14 Apr 2028 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marburg Virus Disease (MVD)Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919210
- Sponsor's protocol ID
- mRNA-1519-P101
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07919210
- Acronym / sponsor ID
- mRNA-1519-P101
- Conditions
- Marburg Virus Disease (MVD)
- Keywords
- Marburg Virus (MARV), Marburg Virus Disease (MVD), Filovirus, Moderna, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 14 Apr 2028 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| mRNA-1519 Dose Level 1 Single Dose | Experimental | Biological: mRNA-1519Participants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1 |
| Placebo Matching Dose Level 1 Single Dose | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1 |
| mRNA-1519 Dose Level 1 Two-Dose | Experimental | Biological: mRNA-1519Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57 |
| Placebo Matching Dose Level 1 Two-Dose | Placebo comparator | Biological: PlaceboParticipants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57 |
| mRNA-1519 Dose Level 2 | Experimental | Biological: mRNA-1519Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1 |
| Placebo Matching Dose Level 2 | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 2 on Day 1 |
| mRNA-1519 Dose Level 3 | Experimental | Biological: mRNA-1519Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1 |
| Placebo Matching Dose Level 3 | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1519Sterile liquid for injection | Biological | mRNA-1519 Dose Level 1 Single Dose, mRNA-1519 Dose Level 1 Two-Dose, mRNA-1519 Dose Level 2, mRNA-1519 Dose Level 3 |
| PlaceboSterile liquid for injection | Biological | Placebo Matching Dose Level 1 Single Dose, Placebo Matching Dose Level 1 Two-Dose, Placebo Matching Dose Level 2, Placebo Matching Dose Level 3 |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Through 7 days after each study intervention
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: 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
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)
2 secondary outcomes
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)
Geometric Mean Titer of Marburg Virus (MARV)-Specific Neutralizing Antibodies (nAbs)
Time frame: Throughout the study (Up to EOS/Day 337)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1519 in people with Marburg Virus Disease (MVD), run by ModernaTX, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCareTeam (+1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Through 7 days after each study intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.