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CVnCoV Safety and Immunogenicity in Health Care Workers
NCT04674189Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2020
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- CureVac
- Modality
- Vaccines & Immunotherapeutics, mRNA Therapeutics
- Drugs
- zorecimeran
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of zorecimeran in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by CureVac. Primary endpoints: Number of Participants Who Experienced a Medically Attended Adverse Event, Number of Participants Who Experienced a Serious Adverse Event and 4 more. Started Dec 2020; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
CVnCoV: Group 1, Lot 1
Two doses of CVnCoV 12 µg (Lot 1) on Day 1 and Day 29
CVnCoV: Group 2, Lot 2
Two doses of CVnCoV 12 µg (Lot 2) on Day 1 and Day 29
Placebo
Two doses of Placebo on Day 1 and Day 29
03
Who it enrols
Adult health care workers, employees, or students in clinical training with no history of SARS-CoV-2 infection or positive serology.
04
Endpoints
Primary
Number of Participants Who Experienced a Medically Attended Adverse Event
Number of Participants Who Experienced a Serious Adverse Event
Number of Participants Who Experienced an Adverse Event of Special Interest
Number of Participants Who Experienced an Unsolicited Adverse Event
Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG)
Secondary
Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies
SARS-CoV-2 Neutralizing Antibody Levels
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