Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04668339
Recruitment Status : Active, not recruiting
First Posted : December 16, 2020
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 25, 2020
First Posted Date  ICMJE December 16, 2020
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE January 7, 2021
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • 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
  • 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
  • Percentages of participants reporting adverse events [ Time Frame: 28 days following each dose administration ]
    spontaneously reported adverse events
  • Percentages of participants reporting serious adverse events [ Time Frame: Day 0 to Day 388 ]
    unsolicited adverse events that meet the definition of serious
  • Percentages of participants reporting medically attended adverse events [ Time Frame: Day 0 to Day 388 ]
    unsolicited adverse events that lead to healthcare provider visit
  • 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
  • Percentages of participants with abnormal chemistry and hematology values [ Time Frame: Day 0 to Day 215 ]
    chemistry and hematology
  • SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Day 0 to Day 388 ]
    neutralizing antibody response
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
Official Title  ICMJE 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
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
  • Corona Virus Infection
Intervention  ICMJE
  • Biological: ARCT-021 single dose priming
    ARCT-021 higher dose (one dose) + placebo (one dose)
  • Biological: ARCT-021 two lower dose priming
    ARCT-021 lower dose (two doses, Day 0 and Day 28)
  • Biological: ARCT-021 two higher dose priming
    ARCT-021 higher dose (two doses, Day 0 and Day 28)
  • Biological: Placebo (two doses), priming
    Placebo (two doses, Day 0 and Day 28)
  • Biological: Randomized booster
    ARCT-021 (single dose) OR placebo, booster
  • Biological: Placebo booster
    Placebo (single dose)
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: ARCT-021 single dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: ARCT-021 two lower dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: ARCT-021 two higher dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: Placebo (two doses), priming
    • Biological: Placebo booster
  • 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
    Interventions:
    • Biological: ARCT-021 single dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: ARCT-021 two lower dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: ARCT-021 two higher dose priming
    • Biological: Randomized 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
    Interventions:
    • Biological: Placebo (two doses), priming
    • Biological: Placebo booster
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2020)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04668339
Other Study ID Numbers  ICMJE ARCT-021-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will only be made available to study investigators at this time.
Responsible Party Arcturus Therapeutics, Inc.
Study Sponsor  ICMJE Arcturus Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arcturus Therapeutics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP