Trial NCT04450004
Publication Ward B, medRxiv, 2020
Primary outcome on the report: Adverse events. The primary immunological outcomes were neutralizing antibody (NAb) responses measured using a VSV pseudovirion assay (Nexelis Inc, Laval, QC) and IFNkƴ and IL-4 cellular responses measured by ELISpot at D0, 21 and 42.

Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.

Bias Author's judgement Support for judgement
Randomization
Some concerns 		Quote: “Healthy seronegative subjects 18-55 years of age who met all inclusion criteria and no exclusion criterion were enrolled and randomized into nine groups.”
Comment: No information on allocation sequence generation. No information on allocation concealment.
Deviations from intervention
Low 		Quote: "The participants and the personnel collecting the safety information and testing laboratories remained blinded to treatment allocation."
Comment: Blinded study (patients, personnel, and investigators).
No participant cross-over.
Data were analyzed using intention-to-treat analysis.
Risk assessed to be low for the outcomes: Adverse events. Withdrawal due to adverse events. Serious adverse events.
Missing outcome data
Low 		Comment: Data from interim analysis.
180 patients randomized; 180 patients analyzed
Data available for all or nearly all participants.
Risk assessed to be low for the outcomes: Adverse events. Withdrawal due to adverse events. Serious adverse events.
Measurement of the outcome
Low 		Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Adverse events. Withdrawal due to adverse events. Serious adverse events.
Selection of the reported results
Low 		Comment: The trial registry is available. The protocol and statistical analysis plan were mentioned in the pre-print, but were not available at the time of assessment.
Adverse events and serious adverse events were listed as outcomes, with timepoints specified in the registry.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcomes: Adverse events. Withdrawal due to adverse events. Serious adverse events.
Overall risk of bias
Some concerns