A Phase 1 interventional study of mRNA-1469 and Placebo in Ebola-Bundibugyo Virus Disease (Ebola-BDBV), sponsored by ModernaTX, Inc.. Not yet recruiting at 1 site in Uganda. Open to participants aged 1 Year to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1, Interventional, and Prevention
The main objective of this trial is to evaluate the safety of mRNA-1469
ModernaTX, Inc. is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For all participants:
For participants 12 to 65 years of age:
For participants 1 to 11 years of age:
For participants 1 to 4 years of age:
Exclusion Criteria:
For all participants:
For participants 12 to 65 years of age:
For participants 1 to 11 years of age:
Note: Other inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 1 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 2 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1.
Biological: Placebo
Participants will receive 1 injection of mRNA-1469 at Dose Level 3 on Day 1.
Biological: mRNA-1469
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1.
Biological: Placebo
Sterile liquid for injection
Sterile liquid for injection
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)
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)
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.
Time frame: At Day 29 and Up to Day 337
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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