Trial NCT04405908
Publication Richmond P,MedRxiv,2020
Primary outcome on the report: The primary objective of this study was to assess the safety and reactogenicity of SCB-2019 when administered alone or as one of two adjuvanted formulations with AS03 or CpG and Alum. The primary immunogenicity endpoint was based on the anti-SCB-2019 IgG antibody titre at each blood sampling timepoint, measured by ELISA.
Bias Author's judgement Support for judgement
Randomization
Some concerns 		Quote: "Participants were assigned a study number at enrolment and vaccinated according to a randomisation list prepared by the study sponsor"
Comment: Unclear allocation sequence and allocation concealment.
Deviations from intervention
Low 		Quote: "All participants and personnel involved in safety data collection and immunogenicity assessments were blinded to the study treatment. Vaccine preparation and administration were performed by different unblinded study personnel, using opacified syringes to maintain the participant blind as the vaccine and placebo are visually different." (report) "Masking: Triple (Participant, Investigator, Outcomes Assessor)" (trial registry)
Comment: Blinded study (patients and investigators).
No participant cross-over.
As we are assessing the effect of assignment to intervention, the intention-to-treat analysis method performed on these outcomes, was considered appropriate.
Risk assessed to be low for all outcomes.
Missing outcome data
Low 		Comment: 151 patients randomized; 150 patients analyzed for safety, 146 for immunogenicity.
Data available for >95% of population.
Risk assessed to be low for the outcomes: Confirmed COVID. Confirmed symptomatic COVID. Hospitalization or death due to COVID. Mortality. Specific antibody seroconversion and GMTs. Neutralizing antibody seroconversion and GMTs. Withdrawals due to adverse events.
Measurement of the outcome
Low 		Quote: "All participants and personnel involved in safety data collection and immunogenicity assessments were blinded to the study treatment"
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Confirmed COVID. Confirmed symptomatic COVID. Hospitalization or death due to COVID. Mortality. Specific antibody seroconversion and GMTs. Neutralizing antibody seroconversion and GMTs. Withdrawals due to adverse events.
Selection of the reported results
Low 		Comment: The trial registry was available.
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: Confirmed COVID. Confirmed symptomatic COVID. Hospitalization or death due to COVID. Mortality. Specific antibody seroconversion and GMTs. Neutralizing antibody seroconversion and GMTs. Withdrawals due to adverse events.
Overall risk of bias
Some concerns