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The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01)

NCT05012943 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19474

Last updated 2025-11-06

Study results available
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Summary

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind study designed to evaluate the safety, immunogenicity and efficacy of ARCT-154 in adult participants to be enrolled in Vietnam.

This study consists of four parts:

Part 1 (Phase 1) will evaluate the safety of the study vaccines in 100 healthy individuals.

Part 2 (Phase 2) will evaluate the safety and immunogenicity of the study vaccines in 300 healthy individuals.

Part 3 (Phase 3a) will evaluate the safety, immunogenicity, and efficacy of the study vaccines in 600 individuals with and without underlying medical conditions.

Part 4 (Phase 3b) will evaluate the safety and efficacy of the study vaccines in 16,000 individuals with and without underlying medical conditions.

Part 5 (Phase 3c) will evaluate the safety and non-inferiority in immunogenicity of ARCT-154 vaccine vs. Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19) in 2400 individuals with and without underlying medical conditions.

In Phase 1, healthy individuals 18 to \< 60 years of age will be enrolled. In Phase 2, 3a, and 3b, individuals 18 years of age and older will be enrolled including individuals with underlying medical conditions that put them at higher risk of complications of COVID-19 disease.

Phase 1, Phase 2, Phase 3a and Phase 3b participants will be randomly assigned to a study group that will receive up to 2 vaccination series. Each vaccination series comprises two vaccinations at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series around 2 months after the first series (on Day 92 and 120).

Participants of Phase 2, 3a who received 2 doses of ARCT-154 vaccine will be rerandomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120.

For Phase 1, Phase 3b and participants in Phase 2 and 3a that received placebo in the first vaccination series, the participants will be switched over to the opposite vaccine in the second series.

There is no second vaccination series for Phase 3c as all participants receive active vaccine in the initial series.

Conditions

  • COVID-19 Vaccines

Interventions

BIOLOGICAL

ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine

ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine

OTHER

Placebo (normal saline)

Normal saline with the same volume as of ARCT-154

BIOLOGICAL

Astra Zeneca COVID-19 vaccine

Astra Zeneca COVID-19 vaccine (ChAdOx1 nCoV-19)

Sponsors & Collaborators

  • Arcturus Therapeutics, Inc.

    collaborator INDUSTRY

  • Vinbiocare Biotechnology Joint Stock Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Drug
Yes

Countries

  • Vietnam

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 NCT05012943 on ClinicalTrials.gov