NCT05037097

A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Arcturus Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will initially enroll approximately 72 adult participants into 2 cohorts (A and B). Cohort A is further sub-divided into two sub-cohorts which include 12 participants who are seronegative, not previously vaccinated at screening (Sub-cohort A1) and 24 participants who are seropositive, not previously vaccinated at screening (Sub-cohort A2). Within the first cohort (Cohort A), Sub-cohort A1 will include a total of 12 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Sub-cohort A2 will include a total of 24 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days. The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses. Additional cohorts may increase the age range of participants up to 80 years of age.

Conditions

• COVID-19
• SARS-CoV-2 Infection
• Corona Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	ARCT-165	Dose 3
BIOLOGICAL	ARCT-154	Dose 2
BIOLOGICAL	ARCT-021	Dose 1

Timeline

• Start date: 2021-08-30
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2021-09-08
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

4 sites across 3 countries: United States, Singapore, South Africa

Regulatory

• FDA-regulated drug study