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

December 6, 2024 updated by: Arcturus Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Solicited Local and Systemic Adverse Events
Time Frame: Up to Day 7 (7 days after vaccine administration)
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
Time Frame: Up to Day 29 (28 days after vaccine administration)
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)
Time Frame: Up to a maximum of approximately 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies
Time Frame: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers
Time Frame: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29
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)
Time Frame: Days 29, and 57
Seroconversion was defined as a 4-fold increase in antibody titer/concentration from baseline. Data is presented for the number of participants seroconverting for neutralizing antibodies and immunoglobulin G (IgG) antibodies against the full-length SARS-CoV-2 recombinant spike protein antigen and spike protein receptor binding domain of the SARS-CoV-2 spike glycoprotein (RBD). ARCT-021-naïve participants were those participants whose first ARCT-021 vaccine administration occurred in this study (Cohort 1a). As pre-specified, data is presented for participants in Cohort 1a only.
Days 29, and 57
Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies
Time Frame: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
GMC data are reported for the S (spike binding antibodies) analyte.
Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29
GMFR in SARS-CoV-2 Binding Antibody Titers
Time Frame: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29
GMFR data are reported for the S (spike binding antibodies) analyte.
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 (Binding Antibodies)
Time Frame: Days 29, and 57
Seroconversion was defined as a 4-fold increase in antibody titer/concentration from baseline. Data is presented for the number of participants seroconverting for binding antibodies and immunoglobulin G (IgG) antibodies against the full-length SARS-CoV-2 recombinant spike protein antigen and spike protein receptor binding domain of the SARS-CoV-2 spike glycoprotein (RBD). ARCT-021-naïve participants were those participants whose first ARCT-021 vaccine administration occurred in this study (Cohort 1a). As pre-specified, data is presented for participants in Cohort 1a only.
Days 29, and 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcturus Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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