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A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults

NCT04668339 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2025-05-15

Study results available
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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

Conditions

  • Covid19
  • SARS-CoV Infection
  • Corona Virus Infection

Interventions

BIOLOGICAL

ARCT-021 single dose priming

ARCT-021 higher dose (one dose) + placebo (one dose)

BIOLOGICAL

ARCT-021 two lower dose priming

ARCT-021 lower dose (two doses, Day 0 and Day 28)

BIOLOGICAL

ARCT-021 two higher dose priming

ARCT-021 higher dose (two doses, Day 0 and Day 28)

BIOLOGICAL

Placebo (two doses), priming

Placebo (two doses, Day 0 and Day 28)

BIOLOGICAL

Randomized booster

ARCT-021 (single dose) OR placebo, booster

BIOLOGICAL

Placebo booster

Placebo (single dose)

Sponsors & Collaborators

  • Arcturus Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States
  • Singapore

Study Locations

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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 NCT04668339 on ClinicalTrials.gov