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

Study results available
· View outcomes & findings →

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037097 on ClinicalTrials.gov