Trial NCT04368988
Publication Formica N, medRxiv, 2021
Dates: 24-08-2020 to 25-09-2020
Funding: Mixed (Coalition for Epidemic Preparedness Innovations; Novavax Inc)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Australia, USA Follow-up duration (days): 1.15 | |
| • Placebo (n = 257 • NVX-CoV2373 5mcg 2 doses (n = 258 • NVX-CoV2373 5mcg 1 dose (n = 257 • NVX-CoV2373 25mcg 2 doses (n = 258 • NVX-CoV2373 25mcg 1 dose (n = 258 |
|
| Inclusion criteria | Men and non-pregnant women 18 to 84 years of age; body mass index of 17 to 35; participants with underlying medical conditions could be enrolled if the conditions were judged clinically to be stable; participants with confirmed COVID-19 presenting with mild symptomatology could be enrolled |
| Exclusion criteria | NR |
| Interventions | |
| Intervention
2 IM doses 5-mcg on days 0, 21 1 IM dose 5-mcg day 0, 1 IM dose placebo day 21 2 IM doses 25-mcg on days 0, 21 1 IM dose 25-mcg day 0, 1 IM dose placebo day 21 |
|
| Control
2 IM doses placebo on days 0, 21 | |
| Participants | |
| Randomized 1288 participants | |
| Characteristics of participants Type of participants: Adults N=1288 630 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Healthy adults (stable comorbidities and confirmed COVID-19 with mild symptoms permitted) aged 18-84 years at 17 centers in Australia and USA | |
| Primary outcome | |
| In the register Serum IgG Antibody Levels Expressed as GMTs (day 35); Serum IgG Antibody Levels Expressed as GMFRs (day 35); Serum IgG Antibody Levels Expressed as SCRs (day 35); Participants with Solicited Adverse Events (AEs) (28 days); Participants with Unsolicited AEs (35 days) | |
| In the report Primary endpoints were immunoglobulin G (IgG) anti-spike protein response, 7-day solicited reactogenicity, and unsolicited adverse events. | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
No, These are interim data, and individual participants remain masked to individual vaccine assignment. Therefore, it would be inappropriate to share individual level results at this time |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Protocol and statistical analysis plan were not available at the time of data collection; the pre-print stated that they will become available at publication. There were no substantive difference between the pre-print article and the registry in population, procedures, interventions or outcomes. This is a preliminary analysis of outcomes in a study in which follow up is ongoing. The study achieved its pre-stated sample size. |