A Phase 1 interventional study of mRNA-1519 and Placebo in Marburg Virus Disease (MVD), sponsored by ModernaTX, Inc.. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 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, reactogenicity, and immunogenicity of mRNA-1519
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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-1519 at Dose Level 1 on Day 1
Biological: mRNA-1519
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1
Biological: Placebo
Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57
Biological: mRNA-1519
Participants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57
Biological: Placebo
Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1
Biological: mRNA-1519
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1
Biological: Placebo
Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1
Biological: mRNA-1519
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: 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)
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)
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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Marburg Virus Disease