Clinical trial NCT04728347: Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Official title: A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SARS-CoV-2
Lead sponsor: Arcturus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Events
timeFrame: Up to Day 7 (7 days after vaccine administration)
measure: Number of Participants With Unsolicited Adverse Events
timeFrame: Up to Day 29 (28 days after vaccine administration)
measure: Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs)
timeFrame: Up to a maximum of approximately 12 months
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies
timeFrame: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
measure: Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers
timeFrame: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29
measure: Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies)
timeFrame: Days 29, and 57
measure: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies
timeFrame: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
measure: GMFR in SARS-CoV-2 Binding Antibody Titers
timeFrame: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29
measure: Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Binding Antibodies)
timeFrame: Days 29, and 57
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
Study officials:
References: