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

Sponsor
Arcturus Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04668339
Collaborator
(none)
581
15
8
13.7
38.7
2.8

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
581 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
sequential assignmentsequential 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 :
Jan 7, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Percentages of participants reporting solicited local adverse events [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 [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 [28 days following each dose administration]

    spontaneously reported adverse events

  4. Percentages of participants reporting serious adverse events [Day 0 to Day 388]

    unsolicited adverse events that meet the definition of serious

  5. Percentages of participants reporting medically attended adverse events [Day 0 to Day 388]

    unsolicited adverse events that lead to healthcare provider visit

  6. Percentages of participants reporting new onset of chronic disease [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 [Day 0 to Day 215]

    chemistry and hematology

  8. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [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 [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 [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 [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 [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 [Through Day 388]

    SARS-CoV-2 anti S1, RBD, N binding antibody responses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arcturus Investigational Site 103 Chandler Arizona United States 85224
2 Arcturus Investigational Site 107 Tucson Arizona United States 85741
3 Arcturus Investigational Site 112 San Diego California United States 92108
4 Arcturus Investigational Site 104 Melbourne Florida United States 32934
5 Arcturus Investigational Site 105 Orlando Florida United States 32806
6 Arcturus Investigational Site 106 Pinellas Park Florida United States 33781
7 Arcturus Investigational Site 109 The Villages Florida United States 32162
8 Arcturus Investigational Site 101 Peoria Illinois United States 61614
9 Arcturus Investigational Site 110 Rockville Maryland United States 20850
10 Arcturus Investigational Site 102 Anderson South Carolina United States 29621
11 Arcturus Investigational Site 111 Austin Texas United States 78705
12 Arcturus Investigational Site 108 Dallas Texas United States 75234
13 Arcturus Investigational Site 204 Singapore Singapore 117599
14 Arcturus Investigational Site 201 Singapore Singapore 169608
15 Arcturus Investigational Site 203 Singapore Singapore 308433

Sponsors and Collaborators

  • Arcturus Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arcturus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04668339
Other Study ID Numbers:
  • ARCT-021-04
First Posted:
Dec 16, 2020
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arcturus Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022