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Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

SARS-CoV-2 Clinical Trial

Official title:
A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

Clinical Trial Summary

This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.

Clinical Trial Description

This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04728347
Study type Interventional
Source Arcturus Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 2
Start date January 4, 2021
Completion date December 28, 2021
View Details
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