The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of solicited, unsolicited adverse and serious adverse events (safety)
Timeframe: 72 months
Vaccine-specific antibody concentration (immunogenicity) measured as optical density that will be converted to concentration
Timeframe: 72 months
Vaccine specific antibody neutralization capability (immunogenicity) represented as proportion of neutralization
Timeframe: 72 months
Vaccine-induced T cell responses (immunogenicity) determined as spot forming units per one million cells.
Timeframe: 72 months