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Status:

TERMINATED

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults

Lead Sponsor:

Arcturus Therapeutics, Inc.

Conditions:

Covid19

SARS-CoV Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candi...

Detailed Description

This is a multiregional, multicenter, Phase 2, randomized, observer-blind study designed to evaluate the safety, reactogenicity, and immunogenicity of the study vaccine in younger and older adult part...

Eligibility Criteria

Inclusion

  • Individuals who:
  • are able to provide consent
  • agree to comply with all study visits and procedures
  • are willing and able to adhere to study restrictions
  • are sexually active and willing to adhere to contraceptive requirements
  • are male or female ≥18 or (in Singapore) ≥21 years of age
  • are medically stable

Exclusion

  • Individuals who:
  • have had SARS-CoV-2 infection or COVID-19 disease.
  • have had cancer except for cancers that were treated and that have low risk of returning
  • have chronic kidney disease
  • have some chronic lung diseases
  • have some heart conditions
  • have compromised immune systems
  • are obese
  • have sickle cell disease or some other blood disorders
  • are current smokers and/or use illegal drugs
  • have Type 2 diabetics
  • are immunocompromised, immunodeficient or have had a transplant
  • have autoimmune disease
  • have other severe or uncontrolled diseases or disease that may interfere with the interpretation of the study
  • have a positive test for hepatitis B or C or human immunodeficiency virus
  • have had a severe reaction to previous investigational vaccines
  • have a fever or are feeling sick close to the time of the first vaccination of the study
  • have positive drug test at screening
  • are pregnant
  • are breastfeeding
  • have a bleeding disorder
  • have previously received an investigational coronavirus vaccine (SARS-CoV(1) or MERS) or who plan to be in other COVID-19 studies
  • have recently been vaccinated with other vaccines
  • have recently received blood products
  • who work at one of the clinic sites participating in this study, work at Arcturus, who work at other companies that monitor the study or close family members to the sites, Arcturus, or partners involved in study monitoring
  • other restrictions may apply

Key Trial Info

Start Date :

January 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2022

Estimated Enrollment :

581 Patients enrolled

Trial Details

Trial ID

NCT04668339

Start Date

January 7 2021

End Date

March 1 2022

Last Update

May 15 2025

Active Locations (15)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (15 locations)

1

Arcturus Investigational Site 103

Chandler, Arizona, United States, 85224

2

Arcturus Investigational Site 107

Tucson, Arizona, United States, 85741

3

Arcturus Investigational Site 112

San Diego, California, United States, 92108

4

Arcturus Investigational Site 104

Melbourne, Florida, United States, 32934