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NCT04668339 · ClinicalTrials.gov registry record · Phase 2
A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
A Phase 2 study, sponsored by Arcturus Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 581
- Enrollment target
NCT04668339: Clinical Trial Phase 2 study, sponsored by Arcturus Therapeutics.
NCT04668339 is a Phase 2 study that was terminated before completion, run by Arcturus Therapeutics. The registered enrollment target is 581 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (337% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04668339, a Phase 2 study, was terminated before completion, sponsored by Arcturus Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 581 participants
- Enrollment target
Study 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 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
Primary Outcome
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Interventions
- BIOLOGICAL ARCT-021 single dose priming
- BIOLOGICAL ARCT-021 two lower dose priming
- BIOLOGICAL ARCT-021 two higher dose priming
- BIOLOGICAL Placebo (two doses), priming
- BIOLOGICAL Randomized booster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 2 |
Why NCT04668339 stopped before completion
NCT04668339 is an interventional study that assigns participants to a tested intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (337% higher).
The record links to 0 conditions, and to 5 interventions - of which ARCT-021 single dose priming is the first listed.
NCT04668339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04668339 about?
NCT04668339 is a clinical study titled "A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults". 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...
What is the current status of trial NCT04668339?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 581 participants. The study started on 2021-01-07. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT04668339?
The interventions under investigation include: ARCT-021 single dose priming (BIOLOGICAL), ARCT-021 two lower dose priming (BIOLOGICAL), ARCT-021 two higher dose priming (BIOLOGICAL), Placebo (two doses), priming (BIOLOGICAL), Randomized booster (BIOLOGICAL).
Who is sponsoring clinical trial NCT04668339?
This trial is sponsored by Arcturus Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04668339's enrollment target sits among peer trials
581 58th of 2000 higher than 1,943 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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