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1000
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Abstract/Summary
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1. The National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE) is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU. The study is an open-labelled, non-randomized, parallel group, phase IV study with historical controls. The primary objective is to assess the effectiveness of vaccination. The study will compare and predict the durability of the minimal protective titre afforded by each of the vaccines against COVID-19 through conducting comprehensive high-throughput SARS-CoV-2 antibody analyses and in-depth characterization of the vaccine-induced cellular immune response. 2. The optimal timing and number of vaccinations against SARS-CoV-2 for recovered, unvaccinated inpatients that have participated in the ACTIV-3/TICO* population has not been determined yet. The subjects receive either one or two doses of mRNA-1273 (Moderna) or BNT162b2 (Pfizer/BioNTech) at different timepoints after recovery. COVID-19 infection is known to generally confer a period of SARS-CoV-2 immunity in most individuals, which would presumably be protective during the study specified period of deferral. COVID-19 infection is also thought to provide an adequate priming effect in most individuals, making the single vaccination arms that are part of this study a scientifically sound avenue for investigation. In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, will be randomized in this 2x2 factorial design to one of four groups. *The ACTIV-3 Therapeutics for Inpatients with COVID-19 (TICO) study is trying to find new treatments for patients hospitalized with COVID-19.
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