A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

Recruiting at 3 trial locations

Overseen By Arcturus Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Arcturus Therapeutics, Inc.

Must not be taking: Allergy injections, Interferon

Disqualifiers: COVID-19 history, Pregnancy, Heart diseases, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing three new COVID-19 vaccines that use self-amplifying RNA in healthy adults aged 21 to 65. It includes both people who have never been vaccinated and those who were vaccinated some time ago. The vaccines work by helping the body recognize and fight COVID-19.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude people who have received certain treatments like allergy injections, interferon, or immunomodulators, so it's best to discuss your specific medications with the study team.

Research Team

Clinical Program Director

Principal Investigator

Arcturus Therapeutics

Eligibility Criteria

Inclusion Criteria

Are willing and able to adhere to study restrictions

Are able to provide consent

Agree to comply with all study visits and procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive study vaccines as 1 or 2 doses depending on cohort, with doses separated by 28 days for some groups

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including antibody response and adverse events

365 days

Treatment Details

Interventions

• ARCT-021
• ARCT-154
• ARCT-165

Participant Groups

Group I: Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-021 on Day 1

Group II: Study Group 7, Adult Participants Previously Vaccinated randomized to receive ARCT-154 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-154 on Day 1

Group III: Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-165 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-165 on Day 1

Group IV: Study Group 5, Adult Participants Seropositive, Not Previously Vaccinated randomized to ARCT-154 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

Group V: Study Group 4, Adult Participants Seropositive, Not Previously Vaccinated to receive ARCT-021 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

Group VI: Study Group 3, Adult Participants Seronegative, Not Previously Vaccinated to receive ARCT-021 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

Group VII: Study Group 2, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-154 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

Group VIII: Study Group 1, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-165 Experimental Treatment 1 Intervention

Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29

Who Is Running the Clinical Trial?

Arcturus Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

22,300+