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A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults

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: NCT04668339
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

Brief Summary:

This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

As 2 doses (at two different dose levels), separated by 28 days or as 1 dose

In adults 18 years of age and older


Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Corona Virus Infection Biological: ARCT-021 single dose priming Biological: ARCT-021 two lower dose priming Biological: ARCT-021 two higher dose priming Biological: Placebo (two doses), priming Biological: Randomized booster Biological: Placebo booster Phase 2

Detailed Description:

This is a multiregional, multicenter, Phase 2, randomized, observer-blind study designed to evaluate the safety, reactogenicity, and immunogenicity of the study vaccine in younger and older adult participants. Enrolled participants will be randomly assigned to receive either study vaccine ARCT-021 or placebo (sterile saline).

Approximately 600 participants (300 each in younger [18 to <56 years of age in United States or 21 to <56 years of age in Singapore] and older [≥56 years of age] participants) will be enrolled (including at least 50% of participants in the older cohort ≥65 years of age). Participants will be stratified by age and then randomly assigned (3 ARCT-021:1 placebo) to receive 2 doses of study vaccine separated by 28 days. At 180 days after second study vaccination (Day 208), participants in Study Groups 1, 2, and 3 will be randomly assigned again to receive a single booster dose of study vaccine (randomly assigned as 1 ARCT-021:1 placebo). Study Group 4 will not be randomized but will receive 1 dose of placebo at Day 208. Study Groups are summarized in Table 1. Study vaccine will be administered in an observer-blind fashion. Participants will be followed for safety and immunogenicity through 180 days after booster vaccination (Day 388). At a subset of clinical sites, all enrolled participants will also undergo blood sampling for evaluation of CMI responses.

Vaccine doses will be assigned as follows:

Younger Age Cohort:

Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose)

Booster Vaccine:

Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo

Older Age Cohort:

Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose)

Booster Vaccine:

Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo

A DSMB will be in place to independently review the safety data of participants. Pausing Rules are also utilized in this study to reduce risk to study participants.

The expected duration of participation for an individual participant is approximately 14 months, inclusive of the Screening period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: sequential assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants
Actual Study Start Date : January 7, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group 1, Younger Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, one dose of Placebo (saline) on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Experimental: Study Group 2, Younger Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Experimental: Study Group 3, Younger Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Placebo Comparator: Study Group 4, Younger Adult Participants
Participants will receive one of Placebo (Saline) on Day 0, one dose of Placebo on Day 28, and one dose of Placebo on Day 208
Biological: Placebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)

Biological: Placebo booster
Placebo (single dose)

Experimental: Study Group 1, Older Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, one dose of Placebo (saline) on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Experimental: Study Group 2, Older Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Experimental: Study Group 3, Older Adult Participants
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)

Biological: Randomized booster
ARCT-021 (single dose) OR placebo, booster

Placebo Comparator: Study Group 4, Older Adult Participants
Participants will receive one dose of Placebo (saline) on Day 0, a second dose of Placebo on Day 28 and a third dose of Placebo on Day 208
Biological: Placebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)

Biological: Placebo booster
Placebo (single dose)




Primary Outcome Measures :
  1. Percentages of participants reporting solicited local adverse events [ Time Frame: for 7 days following each dose administration ]
    Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination

  2. Percentages of participants reporting solicited systemic adverse events [ Time Frame: for 7 days following each dose administration ]
    Adverse events reported daily in a diary that reflect generalized symptoms following vaccination

  3. Percentages of participants reporting adverse events [ Time Frame: 28 days following each dose administration ]
    spontaneously reported adverse events

  4. Percentages of participants reporting serious adverse events [ Time Frame: Day 0 to Day 388 ]
    unsolicited adverse events that meet the definition of serious

  5. Percentages of participants reporting medically attended adverse events [ Time Frame: Day 0 to Day 388 ]
    unsolicited adverse events that lead to healthcare provider visit

  6. Percentages of participants reporting new onset of chronic disease [ Time Frame: Day 0 to Day 388 ]
    unsolicited adverse events associated with new diagnosis of chronic disease

  7. Percentages of participants with abnormal chemistry and hematology values [ Time Frame: Day 0 to Day 215 ]
    chemistry and hematology

  8. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Day 0 to Day 388 ]
    neutralizing antibody response

  9. Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs [ Time Frame: Through Day 388 ]
    neutralizing antibody response

  10. Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through Day 388 ]
    neutralizing antibody response


Secondary Outcome Measures :
  1. SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs [ Time Frame: Day 0 to Day 388 ]
    SARS-CoV-2 anti S1, RBD, N binding antibody responses

  2. Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs [ Time Frame: Through Day 388 ]
    SARS-CoV-2 anti S1, RBD, N binding antibody responses

  3. Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels [ Time Frame: Through Day 388 ]
    SARS-CoV-2 anti S1, RBD, N binding antibody responses



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals who:

  1. are able to provide consent
  2. agree to comply with all study visits and procedures
  3. are willing and able to adhere to study restrictions
  4. are sexually active and willing to adhere to contraceptive requirements
  5. are male or female ≥18 or (in Singapore) ≥21 years of age
  6. are medically stable

Exclusion Criteria:

Individuals who:

  1. have had SARS-CoV-2 infection or COVID-19 disease.
  2. have had cancer except for cancers that were treated and that have low risk of returning
  3. have chronic kidney disease
  4. have some chronic lung diseases
  5. have some heart conditions
  6. have compromised immune systems
  7. are obese
  8. have sickle cell disease or some other blood disorders
  9. are current smokers and/or use illegal drugs
  10. have Type 2 diabetics
  11. are immunocompromised, immunodeficient or have had a transplant
  12. have autoimmune disease
  13. have other severe or uncontrolled diseases or disease that may interfere with the interpretation of the study
  14. have a positive test for hepatitis B or C or human immunodeficiency virus
  15. have had a severe reaction to previous investigational vaccines
  16. have a fever or are feeling sick close to the time of the first vaccination of the study
  17. have positive drug test at screening
  18. are pregnant
  19. are breastfeeding
  20. have a bleeding disorder
  21. have previously received an investigational coronavirus vaccine (SARS-CoV(1) or MERS) or who plan to be in other COVID-19 studies
  22. have recently been vaccinated with other vaccines
  23. have recently received blood products
  24. who work at one of the clinic sites participating in this study, work at Arcturus, who work at other companies that monitor the study or close family members to the sites, Arcturus, or partners involved in study monitoring
  25. other restrictions may apply

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): NCT04668339


Contacts
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Contact: Arcturus Therapeutics (858) 900-2660 clinicaltrials@arcturusrx.com

Locations
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United States, Arizona
Arcturus Investigational Site 103 Not yet recruiting
Chandler, Arizona, United States, 85224
Contact    480-782-5552      
Arcturus Investigational Site 107 Not yet recruiting
Tucson, Arizona, United States, 85741
Contact    520-333-4515      
United States, California
Arcturus Investigational Site 112 Recruiting
San Diego, California, United States, 92108
Contact    619-291-2845      
United States, Florida
Arcturus Investigational Site 104 Recruiting
Melbourne, Florida, United States, 32934
Contact    321-259-3880      
Arcturus Investigational Site 105 Recruiting
Orlando, Florida, United States, 32806
Contact    407-426-9299      
Arcturus Investigational Site 106 Recruiting
Pinellas Park, Florida, United States, 33781
Contact    727-544-6367      
Arcturus Investigational Site 109 Recruiting
The Villages, Florida, United States, 32162
Contact    352-261-0901      
United States, Illinois
Arcturus Investigational Site 101 Recruiting
Peoria, Illinois, United States, 61614
Contact    309-672-1910      
United States, Maryland
Arcturus Investigational Site 110 Recruiting
Rockville, Maryland, United States, 20850
Contact    301-309-8610      
United States, South Carolina
Arcturus Investigational Site 102 Recruiting
Anderson, South Carolina, United States, 29621
Contact    864-305-1411      
United States, Texas
Arcturus Investigational Site 111 Recruiting
Austin, Texas, United States, 78705
Contact    512-201-8032      
Arcturus Investigational Site 108 Recruiting
Dallas, Texas, United States, 75234
Contact    972-241-1222      
Singapore
Arcturus Investigational Site 201 Recruiting
Singapore, Singapore, 169608
Contact    +65 6323 7532      
Sponsors and Collaborators
Arcturus Therapeutics, Inc.
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Responsible Party: Arcturus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04668339    
Other Study ID Numbers: ARCT-021-04
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will only be made available to study investigators at this time.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcturus Therapeutics, Inc.:
SARS-CoV-2 Vaccine
Coronavirus Virus Diseases
RNA COVID 19
COVID 19 Vaccine Arcturus
self amplifying RNA vaccine
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases