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

NCT04728347 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ARCT-021-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited Local and Systemic Adverse Events

  Solicited local adverse events were defined as pain, tenderness, erythema, or swelling at the injection site. Solicited systemic adverse events were defined as fever, fatigue, headache, chills, nausea, vomiting, diarrhoea, myalgia, and arthralgia. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to Day 7 (7 days after vaccine administration)

• Number of Participants With Unsolicited Adverse Events

  Unsolicited adverse events were defined as any spontaneously occurring adverse event (serious and non-serious). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to Day 29 (28 days after vaccine administration)

• 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)

  SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A NOCD was defined as a MAAE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. A MAAE was an adverse event that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to a maximum of approximately 12 months

Secondary Outcomes (6)

• Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies

  Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29

• Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers

  Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29

• Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies)

  Days 29, and 57

• Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies

  Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29

• GMFR in SARS-CoV-2 Binding Antibody Titers

  Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29

Study Arms (2)

ARCT-021

EXPERIMENTAL

Participants will receive a single dose of ARCT-021 on Day 1

Biological: ARCT-021

Long-term follow up from ARCT-021-01

NO INTERVENTION

Participants will not receive intervention but will be followed for safety.

Interventions

ARCT-021 BIOLOGICAL

ARCT-021 single dose

ARCT-021

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who:
• are able to give consent
• must have completed Study ARCT-021-01
• agree to comply with all study visits and procedures
• Only for subjects that will receive ARCT-021 in this study:
• are healthy and medically stable
• are not planning to donate blood or plasma until 28 days after the last dose of ARCT-021.
• 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.
• are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential

You may not qualify if:

• Individuals who:
• are unable to comply with the study visits or procedures in Study ARCT-021-01
• 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:
• have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.
• 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
• have abnormal screening laboratory results
• have uncontrolled diabetes
• use of any prescription or over-the-counter medications within 7 days prior to vaccination

Sponsors & Collaborators

• Arcturus Therapeutics, Inc.: lead

Study Sites (1)

SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital

Singapore, 169608, Singapore

Location

Results Point of Contact

• Title: Arcturus Therapeutics, Inc.
• Organization: Arcturus Therapeutics, Inc.

clinicaltrials@arcturusrx.com

858-900-2660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: January 4, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)