Ebola-Bundibugyo Virus Disease (Ebola-BDBV)Phase 1NCT07737717
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
A Phase 1 study testing mRNA-1469 in people with Ebola-Bundibugyo Virus Disease (Ebola-BDBV), run by ModernaTX, Inc. at 3 sites in Canada.
Trial summary
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
- What is being tested?
- mRNA-1469
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesCanada
- Study dates
- 31 Jul 2026to 30 Sep 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 18.5 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.
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 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 locations and contacts
3 sites in 1 country.
Canada3 sites
Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K6R8
Centricity Research Toronto LMC Multispecialty
Toronto, Ontario, M4G 3E8
Colchester Research Group
Truro, Nova Scotia, B2N 1L2
About this study
Official title: 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
- Being tested
- mRNA-1469, Placebo
- Keywords
- Ebola-Bundibugyo Virus Disease (Ebola-BDBV), Moderna, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1469Biological
Sterile liquid for injection
PlaceboBiological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1469 Dose Level 1 | Experimental | Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1. Receives: Biological: mRNA-1469 |
| Placebo Matching Dose Level 1 | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 2 | Experimental | Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1. Receives: Biological: mRNA-1469 |
| 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-1469 Dose Level 3 | Experimental | Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1. Receives: Biological: mRNA-1469 |
| 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: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: 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)
Measured: Up to End of Study (EOS) (Day 337)
Secondary outcomes (1)
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Measured: At Day 29 and Up to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start31 Jul 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola-Bundibugyo Virus Disease (Ebola-BDBV)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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737717
- Sponsor's protocol ID
- mRNA-1469-P101
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07737717
- Acronym / sponsor ID
- mRNA-1469-P101
- Keywords
- Ebola-Bundibugyo Virus Disease (Ebola-BDBV), Moderna, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Jul 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 and reactogenicity of mRNA-1469
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| mRNA-1469 Dose Level 1 | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1. |
| Placebo Matching Dose Level 1 | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. |
| mRNA-1469 Dose Level 2 | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 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-1469 Dose Level 3 | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 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 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 18.5 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 (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 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.
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-1469Sterile liquid for injection | Biological | mRNA-1469 Dose Level 1, mRNA-1469 Dose Level 2, mRNA-1469 Dose Level 3 |
| PlaceboSterile liquid for injection | Biological | Placebo Matching Dose Level 1, 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: 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)
1 secondary outcome
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Time frame: At Day 29 and Up to 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 24 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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-1469 in people with Ebola-Bundibugyo Virus Disease (Ebola-BDBV), run by ModernaTX, Inc. at 3 sites in Canada.
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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Up to Day 7 (the day of study intervention and 6 subsequent days)). 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 24 Sep 2026.