Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
Conditions
Keywords
Ebola-Bundibugyo Virus Disease (Ebola-BDBV), Moderna, Healthy Participants
Brief summary
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469
Interventions
BIOLOGICALmRNA-1469
Sterile liquid for injection
BIOLOGICALPlacebo
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 18.5 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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 7 (the day of study intervention and 6 subsequent days) |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 28 (the day of study intervention and 27 subsequent days) |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | 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) | Up to End of Study (EOS) (Day 337) |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs) | At Day 29 and Up to Day 337 |
Countries
Canada
Contacts
CONTACTModerna WeCareTeam
Outcome results
None listed