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Phase 1/2 Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480957
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

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 Regimen 1 Biological: ARCT-021 Dose Regimen 2 Other: Placebo Phase 1 Phase 2

Detailed Description:
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. Based upon the safety, immunogenicity and T-cell response data observed in the dose escalation cohorts, dose regimens will be selected for further evaluation in the Phase 2 part of the study in up to two expansion cohorts in younger adults (21 to 55 years) and in up to two elderly subject (56 to 80 years) cohorts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 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
Estimated Study Start Date : July 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: 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 :
  1. 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 :
  1. 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

  2. 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

  3. 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:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Healthy males or females aged 21 to 80 at the time of informed consent.
  2. Body Mass Index 18-35 kg/m2, inclusive, at screening
  3. 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
  4. Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1
  5. Willing and able to comply with protocol-defined procedures and complete all study visits
  6. 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:

  1. Clinically significant abnormalities in medical history
  2. Out of range screening laboratory results
  3. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
  4. Uncontrolled hypertension (BP > 160/100 mm Hg)
  5. Uncontrolled diabetes
  6. Any history of autoimmune disease
  7. Immunodeficiency of any cause
  8. History of Chronic liver disease
  9. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
  10. Recent (within 1 year) history of, or current drug or alcohol abuse
  11. Has any blood dyscrasias or significant disorder of coagulation
  12. 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
  13. 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.
  14. Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.
  15. Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study
  16. 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
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Contact: Steve Hughes, MD 858-900-2660 steveh@arcturusrx.com
Contact: Connie Crowley 858-382-1270 Connie@arcturusrx.com

Locations
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Singapore
SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
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
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Principal Investigator: Jenny Low Guek Hong, MD SingHealth Investigational Medicine Unit (IMU)
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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: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No