Table 1.

Objectives and endpoints

Objectives	Endpoints
Primary
To assess binding antibody responses post dose 2 vaccination with MVA-BN-Filo.	Binding antibody levels against the EBOV GP using FANG ELISA at 21 days post dose 2 (day 78) vaccination with MVA-BN-Filo.
Secondary
To assess binding antibody responses after booster vaccination with Ad26.ZEBOV given at 1 or 2 years after first dose.	Binding antibody levels against the EBOV GP using FANG ELISA at 7 days (excluding the day of vaccination) post booster.
To assess the safety of a heterologous vaccine regimen using Ad26.ZEBOV and MVA-BN-Filo administered at a 56-day interval and a booster vaccine with Ad26.ZEBOV at 1 or 2 years post first dose.	Serious adverse events from first dose vaccination until 6 months post booster. Solicited and unsolicited local and systemic adverse events until 7 days post booster vaccination (day of vaccination and subsequent 7 days) with Ad26.ZEBOV.
Exploratory
To assess binding antibody responses at different time points as indicated in the study time and events overview (figure 1).	Binding antibody levels against the EBOV GP using FANG ELISA at different time points as indicated in the study time and events overview (figure 1).
To assess neutralising antibody response directed against the adenovirus vector prior to vaccination.	Neutralising antibody levels against Ad26 using Ad26 VNA at the first visit.
To assess neutralising antibody response directed against the MVA vector prior to vaccination.	Neutralising antibody levels against MVA-BN-Filo using MVA PRNT assay at the first visit.
To assess seroprevalence of Ebola virus disease prior to vaccination.	Presence of pre-existing human anti-EBOV GP IgG and anti-EBOV NP IgG using LUMINEX assay.

EBOV, Ebola virus; ELISA, enzyme-linked immunosorbent assay; FANG, Filovirus Animal Non-Clinical Group; GP, glycoprotein; NP, nucleoprotein; PRNT, plaque reduction neutralisation test; VNA, virus neutralising assay.