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Virus Therapy
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
Phase 1 & 2
Waitlist Available
Research Sponsored by Arcturus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 7 days following each study vaccination
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- COVID-19
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 7 days following each study vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 7 days following each study vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs
Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs
GMC ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021Experimental Treatment1 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-154Experimental Treatment1 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-165Experimental Treatment1 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-154Experimental Treatment1 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-021Experimental Treatment1 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-021Experimental Treatment1 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-154Experimental Treatment1 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-165Experimental Treatment1 Intervention
Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARCT-165
2021
Completed Phase 2
~80
ARCT-154
2021
Completed Phase 2
~80
ARCT-021
2021
Completed Phase 2
~80
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Arcturus Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
22,379 Total Patients Enrolled
5 Trials studying COVID-19
21,926 Patients Enrolled for COVID-19
Clinical Program DirectorStudy DirectorArcturus Therapeutics
16 Previous Clinical Trials
76,321 Total Patients Enrolled
1 Trials studying COVID-19
1,680 Patients Enrolled for COVID-19