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Clinical Trial Summary

This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.

Clinical Trial Description

The study will initially enroll approximately 72 adult participants into 2 cohorts and may expand enrollment up to 144 participants if additional cohorts are added. The first cohort (Cohort A) will include a total of 36 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days. The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses. Additional cohorts may increase the age range of participants up to 80 years of age. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05037097
Study type Interventional
Source Arcturus Therapeutics, Inc.
Contact Arcturus Therapeutics
Phone (858) 900-2660
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date August 30, 2021
Completion date March 2023

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