Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: ARCT-021

Detailed Description

This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Individuals who:

1. are able to give consent
2. must have completed Study ARCT-021-01

3. agree to comply with all study visits and procedures

   Only for subjects that will receive ARCT-021 in this study:

4. are healthy and medically stable
5. are not planning to donate blood or plasma until 28 days after the last dose of ARCT-021.
6. are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of ARCT-021.
7. are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential

Exclusion Criteria:

Individuals who:

1. are unable to comply with the study visits or procedures in Study ARCT-021-01

2. received placebo in the Parent Study and who are not willing to receive ARCT-021 in this study.

   Only for subjects that will receive ARCT-021 in this study:

3. have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.

4. have a diagnosis of new clinically significant abnormalities including but not limited to

   • Respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations
   • Significant heart conditions
   • Significant neurological conditions
   • Significant blood disorders
   • Newly diagnosed autoimmune disease
   • Major surgery
5. have abnormal screening laboratory results
6. have uncontrolled diabetes
7. use of any prescription or over-the-counter medications within 7 days prior to vaccination
8. have received immunoglobulins and/or any blood or blood products
9. have a bleeding disorder
10. have uncontrolled blood pressure
11. have been treated with another investigational drug, biological agent, or device since completion of the Parent Study

12. have received or plan to receive:

    • A licensed, live vaccine within 4 weeks before or after study vaccination, or
    • A licensed, inactivated vaccine within 2 weeks before or after study vaccination
13. have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
14. other restrictions may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ARCT-021; Participants will receive a single dose of ARCT-021 on Day 1	Biological: ARCT-021; ARCT-021 single dose
NO_INTERVENTION: Long-term follow up from ARCT-021-01; Participants will not receive intervention but will be followed for safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of participants reporting solicited local adverse events	Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination	for 7 days following last study vaccine dose administration
Percentages of participants reporting solicited systemic adverse events	Adverse events reported daily in a diary that reflect generalized symptoms following vaccination	for 7 days following last study vaccine dose administration
Percentages of participants reporting adverse events	Spontaneously reported adverse events	for 28 days following last study vaccine dose administration
Percentages of participants reporting serious adverse events	Unsolicited adverse events that meet the definition of serious	for 12 months following last study vaccine dose administration
Percentages of participants reporting medically attended adverse events	Unsolicited adverse events that lead to healthcare provider visit	for 12 months following last study vaccine dose administration
Percentages of participants reporting new onset of chronic disease	Unsolicited adverse events associated with new diagnosis of chronic disease	for 12 months following last study vaccine dose administration
Percentages of participants with abnormal safety laboratory test values	Chemistry and hematology	for 28 days following last study vaccine dose administration
Percentages of participants with abnormal vital sign assessments	Blood pressure, heart rate, respiratory rate	for 12 months following last study vaccine dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs	Neutralizing antibody response	for 12 months following last study vaccine dose administration for participants dosed in ARCT-021-02 study and for 15 months following last study vaccine dose administration for participants dose in the ARCT-021-01 study
SARS-CoV-2 binding antibody levels, expressed as GMCs	Binding antibody response	for 12 months following last study vaccine dose administration for participants dosed in ARCT-021-02 study and for 15 months following last study vaccine dose administration for participants dose in the ARCT-021-01 study

Collaborators and Investigators

• Sponsor: Arcturus Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2021
• Primary Completion (ACTUAL): December 28, 2021
• Study Completion (ACTUAL): December 28, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ARCT-021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes