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: “Eligible participants were randomized at a 3:3:1:1 ratio to receive one or two 1.0 mg ID injection(s) of INO-4800 or one or two ID injection(s) of placebo.”
Comment: Allocation sequence probably random. No information on allocation concealment. Imbalances in baseline characteristics of 1mg/placebo 1 and 2mg/placebo 2 cohorts appear to be compatible with chance, but characteristics are not reported by each study arm. |
Deviations from intervention |
Low |
Quote: “Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)”
Comment: Blinded study (participants and personnel) All randomized participants who received at least one dose were analysed for safety outcomes. As we are assessing the effect of assignment to intervention, the analysis method performed on these safety outcomes, was considered appropriate. Risk assessed to be low for the outcome: Adverse events. |
Missing outcome data |
Low |
Comment: 401 participants randomized; 399 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcome: Adverse events. |
Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcome: Adverse events. |
Selection of the reported results |
Low |
Comment: The prospective trial registry was available.
Outcome pre-specified. 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 outcome: Adverse events. |
Overall risk of bias |
Some concerns |