A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
NCT ID: NCT04668339
Last Updated: 2025-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
581 participants
INTERVENTIONAL
2021-01-07
2022-03-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
ARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
ARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
ARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
Placebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)
Placebo booster
Placebo (single dose)
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
ARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
ARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
ARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
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
Placebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)
Placebo booster
Placebo (single dose)
Interventions
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ARCT-021 single dose priming
ARCT-021 higher dose (one dose) + placebo (one dose)
ARCT-021 two lower dose priming
ARCT-021 lower dose (two doses, Day 0 and Day 28)
ARCT-021 two higher dose priming
ARCT-021 higher dose (two doses, Day 0 and Day 28)
Placebo (two doses), priming
Placebo (two doses, Day 0 and Day 28)
Randomized booster
ARCT-021 (single dose) OR placebo, booster
Placebo booster
Placebo (single dose)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Arcturus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Arcturus Investigational Site 103
Chandler, Arizona, United States
Arcturus Investigational Site 107
Tucson, Arizona, United States
Arcturus Investigational Site 112
San Diego, California, United States
Arcturus Investigational Site 104
Melbourne, Florida, United States
Arcturus Investigational Site 105
Orlando, Florida, United States
Arcturus Investigational Site 106
Pinellas Park, Florida, United States
Arcturus Investigational Site 109
The Villages, Florida, United States
Arcturus Investigational Site 101
Peoria, Illinois, United States
Arcturus Investigational Site 110
Rockville, Maryland, United States
Arcturus Investigational Site 102
Anderson, South Carolina, United States
Arcturus Investigational Site 111
Austin, Texas, United States
Arcturus Investigational Site 108
Dallas, Texas, United States
Arcturus Investigational Site 204
Singapore, , Singapore
Arcturus Investigational Site 201
Singapore, , Singapore
Arcturus Investigational Site 203
Singapore, , Singapore
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARCT-021-04
Identifier Type: -
Identifier Source: org_study_id
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