Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\&J) more than 4 months prior to recruitment
• Subjects between 18 and 50 years of age at time of randomization
• Subject must be willing and able to provide informed consent
• The subject must be in possession of an identification card (or other identification document)
• Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination
• Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant
Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = homologous vaccination scheme.
Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = heterologous vaccination scheme.
Participants previously vaccinated with Ervebo®, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = heterologous vaccination scheme.