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A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults

COPD | CHF | Respiratory Syncytial Virus | Vaccine | CAD | Transplant | RSV

RSV is a common cause of respiratory tract infection, which involves the passage formed by the mouth, nose, throat, and lungs. It is contagious and can be easily spread.
Vaccines prepare your immune system for fighting illnesses by causing your body to make antibodies. Antibodies are special proteins in the blood that help to protect you from infectious diseases caused by bacteria and viruses.
This is a Phase 3 clinical trial to study the investigational vaccine called mRNA-1345, for the prevention of RSV. It has not yet been approved by Health Canada.
The main goals of this trial are to understand the safety and tolerability of the trial vaccine.

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Conditions de participation

  • Sexe:

    Female, Male

  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:
Adults 18 years of age or older
Cohort 1: Diagnosis of coronary artery disease (CAD) and/or congestive heart failure (CHF), Chronic lung disease or Stable type 1 or type 2 diabetes mellitus (DM)
Or
Cohort 2: Solid organ transplant (SOT) (kidney, liver or lung transplant) greater than 180 days prior to consent and receiving immunosuppressive therapy

Not pregnant or breastfeeding
Exclusion Criteria:
-Can not be in another trial with investigational products -Clinically unstable medical condition
-Dermatological condition
-History of Anaphylaxis or hypersensitivity to components or prior vaccination
-Bleeding disorder -Guillain-Barre syndrome
-Received or planning to receive other vaccinations
-Received blood products within 90 days -Acutely ill or febrile
-History of myocarditis, pericarditis or myopericarditis -Donated blood products within 28 days
-Previous treatment with Alemtuzumab, rituximab or plasmapheresis
-Biopsy proven or clinically diagnosed rejection

Lieu de l'étude

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Research Coordinator

[email protected]
780-407-6945
Étude parrainée par
University of Alberta
Participants recherchés
Plus d'informations
ID de l'étude: Pro00131101