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NCT05037097 · ClinicalTrials.gov registry record · Phase 1
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
A Phase 1 study, sponsored by Arcturus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT05037097: Completed Phase 1 study, sponsored by Arcturus Therapeutics.
NCT05037097 is a Phase 1 study that has completed, run by Arcturus Therapeutics. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05037097, a Phase 1 study, has completed, sponsored by Arcturus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.
Primary Outcome
Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regar
Interventions
- BIOLOGICAL ARCT-165
- BIOLOGICAL ARCT-154
- BIOLOGICAL ARCT-021
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2023-12-19 |
| Phase | Phase 1 |
What the finished NCT05037097 record still lists
NCT05037097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which ARCT-165 is the first listed.
NCT05037097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05037097 about?
NCT05037097 is a clinical study titled "A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults". This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.
What is the current status of trial NCT05037097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2021-08-30. Estimated completion is 2023-12-19.
What interventions are being tested in trial NCT05037097?
The interventions under investigation include: ARCT-165 (BIOLOGICAL), ARCT-154 (BIOLOGICAL), ARCT-021 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05037097?
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 NCT05037097's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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