Not yet recruiting NCT07737717
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mRNA-1469, Placebo.
- Who it may be relevant to
- Registry conditions: Ebola-Bundibugyo Virus Disease (Ebola-BDBV). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants 18 to 65 Years of Age
Overview
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469
Interventions
- Biological mRNA-1469
Sterile liquid for injection - Biological Placebo
Sterile liquid for injection
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs) [Time frame: At Day 29 and Up to Day 337]
Eligibility criteria
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.
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 exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 3 centers
- Canadian Center for Vaccinology — Halifax
- Colchester Research Group — Truro
- Centricity Research Toronto LMC Multispecialty — Toronto
Identifiers
NCT: NCT07737717 · mRNA-1469-P101