Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
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| ClinicalTrials.gov Identifier: NCT04480957 |
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Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : August 17, 2020
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Sponsor:
Arcturus Therapeutics, Inc.
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.
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Brief Summary:
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 | Biological: ARCT-021 Dose 1 Biological: ARCT-021 Dose 2 Biological: ARCT-021 Dose 3 Biological: ARCT-021 Dose 4 Biological: ARCT-021 Dose Regimen 1 Biological: ARCT-021 Dose Regimen 2 Other: Placebo | Phase 1 Phase 2 |
Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled, adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult subjects. 0.9% sterile saline will serve as a placebo control. Study drug (ARCT-021 or control) will be administered as an intramuscular (IM) injection. The study comprises two parts. In the Phase 1 part escalating dose levels given as a single injection to younger adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to 55 years) and in two elderly subject (56 to 80 years) cohorts.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 Randomised, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Immunogenicity of ARCT-021 in Healthy Adult Subjects |
| Actual Study Start Date : | August 4, 2020 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | January 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Escalation Cohort dose 1 of ARCT-021, 21 - 55 years
Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose 1
ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Escalation Cohort dose 2 of ARCT-021, 21 -55 years
Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose 2
ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Escalation Cohort dose 3 of ARCT-021, 21 - 55 years
Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose 3
ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Escalation Cohort dose 4 of ARCT-021, 21 - 55 years
Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose 4
ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Expansion cohort dose regimen 1, 21 - 55 years.
Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose Regimen 1
ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Expansion cohort dose regimen 2, 21 - 55 years.
Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose Regimen 2
ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Expansion cohort dose regimen 1, 56 - 80 years
Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose Regimen 1
ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
| Experimental: Expansion cohort dose regimen 2, 56 - 80 years
Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
|
Biological: ARCT-021 Dose Regimen 2
ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
Other: Placebo
Sterile 0.9% saline
|
Primary Outcome Measures :
- Incidence, severity and dose-relationship of AEs [ Time Frame: 56 days ]
Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Secondary Outcome Measures :
- Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody [ Time Frame: Up to 56 days ]
SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT
- Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels [ Time Frame: Up to 56 days ]
SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer
- Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels [ Time Frame: Up to 56 days ]
GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point
Other Outcome Measures:
- Increase in SARS-CoV-2--spike protein-specific binding antibody levels [ Time Frame: Up to 56 days ]
GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point
- Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre [ Time Frame: Up to 56 days ]
GMT for SARS-CoV-2--spike protein-specific binding antibody levels
- Mean SARS-CoV-2--spike protein-specific binding antibody titre [ Time Frame: Up to 56 days ]
Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels
- SARS-CoV-2-specific serum neutralizing antibody seroconversion rate [ Time Frame: 56 days ]
Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies
- SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline) [ Time Frame: 56 days ]
Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels
Information from the National Library of Medicine 
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males or females aged 21 to 80 at the time of informed consent.
- Body Mass Index 18-35 kg/m2, inclusive, at screening
- Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits
- Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1
- Willing and able to comply with protocol-defined procedures and complete all study visits
- Males must be surgically sterile or willing to use adequate contraception; females must be post-menopausal, surgically sterile or willing to use adequate contraception
Exclusion Criteria:
- Pregnant or breast feeding
- Clinically significant abnormalities in medical history
- Out of range screening laboratory results
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- Uncontrolled hypertension (BP > 160/100 mm Hg)
- Uncontrolled diabetes
- Any history of autoimmune disease
- Immunodeficiency of any cause
- History of Chronic liver disease
- Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
- Recent (within 1 year) history of, or current drug or alcohol abuse
- Has any blood dyscrasias or significant disorder of coagulation
- Has an acute illness, as determined by the investigator, with or without fever [temperature >38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.
- Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study
- Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480957
Contacts
| Contact: Steve Hughes, MD | 858-900-2660 | steveh@arcturusrx.com | |
| Contact: Connie Crowley | 858-382-1270 | Connie@arcturusrx.com |
Locations
| Singapore | |
| SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital | Recruiting |
| Singapore, Singapore, 169608 | |
| Contact: Michellore Aguilar +65 6322 7544 imu@singhealth.com.sg | |
| Principal Investigator: Jenny Low Guek Hong, MD | |
Sponsors and Collaborators
Arcturus Therapeutics, Inc.
Investigators
| Principal Investigator: | Jenny Low Guek Hong, MD | SingHealth Investigational Medicine Unit (IMU) |
| Responsible Party: | Arcturus Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04480957 |
| Other Study ID Numbers: | ARCT-021-01 |
| First Posted: | July 22, 2020 Key Record Dates |
| Last Update Posted: | August 17, 2020 |
| Last Verified: | August 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |