Ebola Virus Disease Clinical Trial
Official title:
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
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.
The aim of this randomized controlled with four arms is to investigate whether individuals previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous and heterologous vaccine schedules. We hypothesize that heterologous booster vaccine schedules generate a non-inferior boosting in antibodies and cellular responses against Ebola virus as compared to homologous schedules and incite a similar safety profile. Based on the predefined variables (living place and time since vaccination), the research team will pre-select and re-contact individuals previously included in the Phase III EBOVAC vaccine database, EBOSURV participant database, and the Programme Élargi de Vaccination (PEV) database. Participants will be contacted by phone and, if they agree to participate, they are scheduled on predefined screening/recruitment days taken place at the 2 recruitment sites: INRB Goma and INRB Kinshasa. A total of 624 participants will be included, 312 will be previously vaccinated with Zabdeno/Mvabea® and 312 participants with Ervebo®. Within those two groups, half of the participants (n=156) will be randomized to a single Ervebo® booster vaccine and the other half (n=156) to a single Zabdeno® booster vaccine. Participants will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of antibody- and cellular response against EBOV between homologous and heterologous schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations. An additional 50 non-vaccinated participants will be recruited in Kinshasa for assay optimization. In case of insufficient participants living close to the recruitment centers, a community outreach will be undertaken with a lower amount of visits for logistical reasons. ;
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