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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Covid19, SARS-CoV Infection, Corona Virus Infection

In brief

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 candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older

Key facts

Study ID

NCT04668339

Run by

Arcturus Therapeutics, Inc.

People needed

581

Starts

2021-01-07

Expected to finish

2022-03-01

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arcturus Investigational Site 103 — Chandler, Arizona, United States
• Arcturus Investigational Site 107 — Tucson, Arizona, United States
• Arcturus Investigational Site 112 — San Diego, California, United States
• Arcturus Investigational Site 104 — Melbourne, Florida, United States
• Arcturus Investigational Site 105 — Orlando, Florida, United States
• Arcturus Investigational Site 106 — Pinellas Park, Florida, United States
• Arcturus Investigational Site 109 — The Villages, Florida, United States
• Arcturus Investigational Site 101 — Peoria, Illinois, United States
• Arcturus Investigational Site 110 — Rockville, Maryland, United States
• Arcturus Investigational Site 102 — Anderson, South Carolina, United States
• Arcturus Investigational Site 111 — Austin, Texas, United States
• Arcturus Investigational Site 108 — Dallas, Texas, United States
• Arcturus Investigational Site 204 — Singapore, Singapore
• Arcturus Investigational Site 201 — Singapore, Singapore
• Arcturus Investigational Site 203 — Singapore, Singapore

Full record on ClinicalTrials.gov

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