Ebola-Bundibugyo Virus Disease (Ebola-BDBV)Phase 1NCT07919197
A Study to Investigate the Safety and Immunogenicity of mRNA-1469 in African Participants 1 to 65 Years of Age
A Phase 1 study testing mRNA-1469 in people with Ebola-Bundibugyo Virus Disease (Ebola-BDBV), run by ModernaTX, Inc. at 1 site in Uganda.
Trial summary
The main objective of this trial is to evaluate the safety of mRNA-1469 Read more about this study
- Who is it for?
- Ages 1 year 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
- 224 participants
- Where
- 1 siteUganda
- Study dates
- 2 Nov 2026to 1 Feb 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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For all participants:
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- For participants 12 to 65 years of age:
- 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.
- For participants 1 to 11 years of age:
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- Female participants who have reached menarche may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
- For participants 1 to 4 years of age:
- Participant was born born at ≥37 weeks gestation, with a minimum birth weight of 2.5 kg, without fetal growth restriction, and the participant's length and weight are both above the third percentile for age according to the WHO Child Growth Standard.
Who cannot join
- For all participants:
- 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 filovirus pathogens (including Ebola Zaire, Ebola Sudan, and Marburg).
- 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.
- Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) Abs positive at Screening.
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- HIV infection, per local testing algorithm.
- History of active tuberculosis requiring treatment in the past 3 years.
- Acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- 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.
- For participants 12 to 65 years of age:
- Abnormal Screening clinical laboratory values >Grade 1 for total white blood cell count, hemoglobin, alanine aminotransferase, creatinine, or platelets.
- Known history of poorly controlled hypertension (per determination of the Investigator), or systolic blood pressure >160 mmHg at the Screening or Baseline (Day 1) visit.
- Known history of hypotension or systolic blood pressure <85 mmHg at the Screening or Baseline (Day 1) visit.
- For participants 1 to 11 years of age:
- Current or past diagnosis of epilepsy or seizure disorder, or any history of febrile seizure.
- Participants who have recently received treatment for acute, uncomplicated malaria are eligible for participation if at least 3 days have elapsed from the conclusion treatment.
- 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 1b, Observer-Blind, Placebo-Controlled Study to Investigate the Safety and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in African Participants 1 to 65 Years of Age
The main objective of this trial is to evaluate the safety of mRNA-1469
- Being tested
- mRNA-1469, Placebo
- Keywords
- Ebola-Bundibugyo Virus Disease (Ebola-BDBV), Moderna, Healthy Participants, Africa
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 3 - Adults 18-65 Years | 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 - Adults 18-65 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 3 - Adolescents 12-17 Years | 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 - Adolescents 12-17 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 1 - Children 5-11 Years | 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 - Children 5-11 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 2 - Children 5-11 Years | 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 - Children 5-11 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 3 - Children 5-11 Years | 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 - Children 5-11 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 1 - Children 1-4 Years | 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 - Children 1-4 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 2 - Children 1-4 Years | 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 - Children 1-4 Years | Placebo comparator | Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1. Receives: Biological: Placebo |
| mRNA-1469 Dose Level 3 - Children 1-4 Years | 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 - Children 1-4 Years | 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 (2)
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Measured: At Day 29 and Up to Day 337
Percentage of Participants with Seroresponse in Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Seroresponse is defined as bAb value change from baseline (preinjection Day 1) below the lower limit of quantification (LLOQ) to ≥2 × LLOQ, or at least a 2-fold rise from baseline if baseline is ≥LLOQ.
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 posted5 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (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
- 224 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
- NCT07919197
- Sponsor's protocol ID
- mRNA-1469-P102
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Observer-Blind, Placebo-Controlled Study to Investigate the Safety and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in African Participants 1 to 65 Years of Age
- ClinicalTrials.gov ID
- NCT07919197
- Acronym / sponsor ID
- mRNA-1469-P102
- Keywords
- Ebola-Bundibugyo Virus Disease (Ebola-BDBV), Moderna, Healthy Participants, Africa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 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 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
- 16
| Arm | Type | Receives |
|---|---|---|
| mRNA-1469 Dose Level 3 - Adults 18-65 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1. |
| Placebo Matching Dose Level 3 - Adults 18-65 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. |
| mRNA-1469 Dose Level 3 - Adolescents 12-17 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1. |
| Placebo Matching Dose Level 3 - Adolescents 12-17 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. |
| mRNA-1469 Dose Level 1 - Children 5-11 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1. |
| Placebo Matching Dose Level 1 - Children 5-11 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. |
| mRNA-1469 Dose Level 2 - Children 5-11 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1. |
| Placebo Matching Dose Level 2 - Children 5-11 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 2 on Day 1. |
| mRNA-1469 Dose Level 3 - Children 5-11 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1. |
| Placebo Matching Dose Level 3 - Children 5-11 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. |
| mRNA-1469 Dose Level 1 - Children 1-4 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1. |
| Placebo Matching Dose Level 1 - Children 1-4 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 1 on Day 1. |
| mRNA-1469 Dose Level 2 - Children 1-4 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1. |
| Placebo Matching Dose Level 2 - Children 1-4 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 2 on Day 1. |
| mRNA-1469 Dose Level 3 - Children 1-4 Years | Experimental | Biological: mRNA-1469Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1. |
| Placebo Matching Dose Level 3 - Children 1-4 Years | Placebo comparator | Biological: PlaceboParticipants will receive 1 injection of Placebo matching Dose Level 3 on Day 1. |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 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.
- Female participants who have reached menarche may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
- Participant was born born at ≥37 weeks gestation, with a minimum birth weight of 2.5 kg, without fetal growth restriction, and the participant's length and weight are both above the third percentile for age according to the WHO Child Growth Standard.
Key exclusion criteria (18 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 filovirus pathogens (including Ebola Zaire, Ebola Sudan, and Marburg).
- 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.
- Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) Abs positive at Screening.
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 - Children 1-4 Years, mRNA-1469 Dose Level 1 - Children 5-11 Years, mRNA-1469 Dose Level 2 - Children 1-4 Years, mRNA-1469 Dose Level 2 - Children 5-11 Years, mRNA-1469 Dose Level 3 - Adolescents 12-17 Years, mRNA-1469 Dose Level 3 - Adults 18-65 Years, mRNA-1469 Dose Level 3 - Children 1-4 Years, mRNA-1469 Dose Level 3 - Children 5-11 Years |
| PlaceboSterile liquid for injection | Biological | Placebo Matching Dose Level 1 - Children 1-4 Years, Placebo Matching Dose Level 1 - Children 5-11 Years, Placebo Matching Dose Level 2 - Children 1-4 Years, Placebo Matching Dose Level 2 - Children 5-11 Years, Placebo Matching Dose Level 3 - Adolescents 12-17 Years, Placebo Matching Dose Level 3 - Adults 18-65 Years, Placebo Matching Dose Level 3 - Children 1-4 Years, Placebo Matching Dose Level 3 - Children 5-11 Years |
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)
2 secondary outcomes
Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs)
Time frame: At Day 29 and Up to Day 337
Percentage of Participants with Seroresponse in 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 5 Nov 2026.
Related trials for Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
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-1469 in people with Ebola-Bundibugyo Virus Disease (Ebola-BDBV), run by ModernaTX, Inc. at 1 site in Uganda.
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 9 inclusion and 18 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 Uganda. 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: 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 5 Nov 2026.