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A decision was made to terminate the study for operational/business reasons. This study was not terminated for reasons of safety or immunogenicity.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCT-021 | Experimental | Participants will receive a single dose of ARCT-021 on Day 1 |
|
| Long-term follow up from ARCT-021-01 | No Intervention | Participants will not receive intervention but will be followed for safety. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARCT-021 | Biological | ARCT-021 single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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
have abnormal screening laboratory results
have uncontrolled diabetes
use of any prescription or over-the-counter medications within 7 days prior to vaccination
have received immunoglobulins and/or any blood or blood products
have a bleeding disorder
have uncontrolled blood pressure
have been treated with another investigational drug, biological agent, or device since completion of the Parent Study
have received or plan to receive:
have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
other restrictions may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital | Singapore | 169608 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1. |
| FG001 | Cohort 1b | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1. |
| FG002 | Cohort 2 Younger Adults | Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. |
| FG003 | Cohort 2: Older Adults | Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data presented for all enrolled participants. As pre-specified, baseline characteristics are presented per sub-cohort (younger and older adults) for Cohort 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1. |
| BG001 | Cohort 1b |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohort 1b, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02. As pre-specified, data is reported for Cohort 1 only. | Posted | Count of Participants | Participants | Up to Day 7 (7 days after vaccine administration) |
|
Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1a | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic stroke | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcturus Therapeutics, Inc. | Arcturus Therapeutics, Inc. | 858-900-2660 | clinicaltrials@arcturusrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2021 | Jul 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2021 | Dec 4, 2024 | SAP_002.pdf |
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| Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies) | 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 | 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 | 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) | 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 |
Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1. |
| BG002 | Cohort 2: Younger Adults | Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. |
| BG003 | Cohort 2: Older Adults | Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
| OG001 | Cohort 1b | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1. |
|
|
| Primary | 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. | Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohort 1b, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02. As pre-specified, data is reported for Cohort 1 only. | Posted | Count of Participants | Participants | Up to Day 29 (28 days after vaccine administration) |
|
|
|
| Primary | 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. | Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2). | Posted | Count of Participants | Participants | Up to a maximum of approximately 12 months |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 who had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29 |
|
|
|
| Secondary | Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies) | 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. | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Count of Participants | Participants | Days 29, and 57 |
|
|
|
| Secondary | Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies | GMC data are reported for the S (spike binding antibodies) analyte. | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 who had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Arbitrary units per milliliter (AU/mL) | Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29 |
|
|
|
| Secondary | GMFR in SARS-CoV-2 Binding Antibody Titers | GMFR data are reported for the S (spike binding antibodies) analyte. | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29 |
|
|
|
| Secondary | Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Binding Antibodies) | 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. | Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Count of Participants | Participants | Days 29, and 57 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Cohort 1b | Participants who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1. | 0 | 12 | 1 | 12 | 1 | 12 |
| EG002 | Cohort 2: Younger Adults | Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. | 0 | 25 | 0 | 25 | 3 | 25 |
| EG003 | Cohort 2: Older Adults | Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study [NCT04480957]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study. | 0 | 16 | 0 | 16 | 0 | 16 |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA v23.0 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Unsolicited Adverse Events Associated with NOCD |
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| MAAEs |
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| Day 29 |
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| Day 57 |
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| Day 29 |
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| Day 57 |
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| Day 29 |
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| Day 57 |
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| Day 29 |
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| Day 57 |
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