Clinical Trials in the UK / NCT07919210
Starting soon
Phase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
NCT07919210 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Marburg Virus Disease (MVD)
Investigational drug(s) / intervention(s)
mRNA-1519Placebo
mRNA-1519: Sterile liquid for injection
Placebo: Sterile liquid for injection
Study summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519
Eligibility
Key Inclusion Criteria:
* 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:
* 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.
Primary outcome measure(s)
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Through 7 days after each study intervention
- Number of Participants with Unsolicited Adverse Events (AEs) — Through 28 days after each study intervention
- Number of Participants with Medically Attended Adverse Events (MAAEs) — 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) — Up to End of Study (EOS) (Day 337)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Oxford | Oxford | United Kingdom |
More ModernaTX, Inc. trials in the UK
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07919210 on ClinicalTrials.gov ↗ ← All trials in the UK