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.
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)
Participants who previously experienced active Ebola Virus Disease (EVD)
Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine
Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J&J) vaccine
Parallel
Zabdeno® booster
DrugA single Zabdeno® booster vaccination
Ervebo® booster
DrugA single Ervebo® booster vaccination
To assess non-inferiority in EBOV-specific IgG levels elicited by a heterologous to a homologous booster vaccine schedule, by type of primary vaccination, 21 days after administration of the booster.
FANG ELISA units/mL of anti-EBOV IgG
To assess the safety of heterologous and homologous booster vaccine schedules, by type of primary vaccine schedule
* The occurrence of solicited local Adverse Events (AEs) \[Up to Day 7\] * The occurrence of solicited systemic AEs \[Up to Day 7\] * The occurrence of unsolicited AEs \[Up to Day 21\] * The occurrence of Serious Adverse Events (SAE's) \[Up to Month 6\]
To compare the EBOV-specific IgG levels at D21 across all vaccine combinations
\- FANG ELISA units/mL of anti-EBOV IgG at D21 after vaccination
To compare the fold change between D0 and D21 across all vaccine combinations
\- Fold change in FANG ELISA units/mL of anti-EBOV IgG between D0 and D21
To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints
\- The Mean Fluorescence Intensity (MFI) IgG levels against the GP variants \[multiplexed Luminex assay - at D0, D3, D7, D21, M6\]
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Institute of Tropical Medicine, Belgium
Lead sponsor
Institut National pour la Recherche Biomedicale (INRB)
Collaborator