Trial NCT04583995; EudraCT 2020-004123-16
Publication Heath P, Clin Infect Dis, 2022
Dates: 2020-09-28 to 2020-11-28
Funding: Private (Novavax, Inc)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / UK Follow-up duration (months): 7.5 | |
| 5 mcg NVX-CoV2373 (n=7569) Placebo (n=7569) |
|
| Inclusion criteria | Men and non-pregnant women 18 to 84 years old (inclusive); healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (and receiving highly active antiretroviral therapy) and cardiac and respiratory diseases |
| Exclusion criteria | History of documented Covid-19; treatment with immunosuppressive therapy; diagnosis with an immunodeficient condition |
| Interventions | |
| Intervention
2 IM doses of 5 mcg NVX-CoV2373, 21 days apart |
|
| Control
2 IM doses of placebo, 21 days apart | |
| Participants | |
| Randomized 15,185 participants | |
| Characteristics of participants Type of participants: Adults N=15,185 7210 males Children: 0 Pregnant women: 0 Mean age: Age range: 18-84 | |
| Description of participants Adults 18 to 84 years old who were healthy or had stable chronic medical conditions with no history of COVID-19 at 33 centres in the UK. | |
| Primary outcome | |
| In the register Number of participants, testing serologically negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline, with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 with onset from Day 28 through the length of the study. (NCT04583995) | |
| In the report Efficacy of the NVX-CoV2373 vaccine against the first occurrence of virologically confirmed symptomatic mild, moderate, or severe Covid-19 with onset at least 7 days after the second dose among participants who were seronegative at baseline, as determined by the results of testing for anti–nucleocapsid antibody. | |
| Variants description | |
Variants
| |
| Description Variant name:Alpha Direct evidence Method: post-hoc analysis Missing outcome results: 11 cases (10.37%) with no sequence data (1 in vaccines arm, 10 in control arm) Indirect evidence "The Alpha variant was the most prevalent strain in the United Kingdom between January and May 2021..." | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, With publication |
| 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 |
Variant alpha: Some concerns |
| General comment | In addition to the published article, the trial registries (one prospective), study protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were no major differences between the registries and protocol and the pre-print article in population, procedures, interventions and outcomes. The study achieved its pre-specified target sample size. Interim analysis. Follow up is ongoing. This trial was updated on July 14th, 2021 after trial publication. This trial was further updated on October 27th, 2022 after publication of results at completion of the trial. |