A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
NCT05037097 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-10-15
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.
Conditions
- COVID-19
- SARS-CoV-2 Infection
- Corona Virus Infection
Interventions
- BIOLOGICAL
-
ARCT-165
Dose 3
- BIOLOGICAL
-
ARCT-154
Dose 2
- BIOLOGICAL
-
ARCT-021
Dose 1
Sponsors & Collaborators
-
Arcturus Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Program Director · Arcturus Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-30
- Primary Completion
- 2023-12-19
- Completion
- 2023-12-19
- FDA Drug
- Yes
Countries
- United States
- Singapore
- South Africa
Study Locations
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