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A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines 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: NCT05037097
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

Study Description
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Brief Summary:
This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Corona Virus Infection Biological: ARCT-165 Biological: ARCT-154 Biological: ARCT-021 Phase 1 Phase 2

Detailed Description:

The study will initially enroll approximately 72 adult participants into 2 cohorts and may expand enrollment up to 144 participants if additional cohorts are added.

The first cohort (Cohort A) will include a total of 36 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days.

The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses.

Additional cohorts may increase the age range of participants up to 80 years of age.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will evaluate 3 investigational vaccines in parallel.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer Blind
Primary Purpose: Treatment
Official Title: A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group 1, Adult Participants Not Previously Vaccinated randomized to receive ARCT-165
Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29
 Biological: ARCT-165
Dose 3
Experimental: Study Group 2, Adult Participants Not Previously Vaccinated randomized to receive ARCT-154
Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29
 Biological: ARCT-154
Dose 2
Experimental: Study Group 3, Adult Participants Not Previously Vaccinated to receive ARCT-021
Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29
 Biological: ARCT-021
Dose 1
Experimental: Study Group 4, Adult Participants Previously Vaccinated randomized to receive ARCT-165
Participants will receive one dose of ARCT-165 on Day 1
 Biological: ARCT-165
Dose 3
Experimental: Study Group 5, Adult Participants Previously Vaccinated randomized to receive ARCT-154
Participants will receive one dose of ARCT-154 on Day 1
 Biological: ARCT-154
Dose 2
Experimental: Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-021
Participants will receive one dose of ARCT-021 on Day 1
 Biological: ARCT-021
Dose 1


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants reporting solicited local or systemic adverse events [ Time Frame: For 7 days following each study vaccination ]
    Solicited adverse events reported daily in a diary that reflect generalized symptoms or findings at the injection site following each vaccination

  2. Percentage of participants reporting unsolicited adverse events [ Time Frame: For 28 days following each study vaccination ]
    Spontaneously reported adverse events

  3. Percentage of participants reporting medically attended adverse events [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Medically attended adverse event is an AE that leads to an unscheduled visit with a health care provider

  4. Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Unsolicited adverse events that meet stopping rules

  5. Percentage of participants reporting serious adverse events [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Unsolicited adverse events that meet the definition of serious

  6. SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Neutralizing antibody response

  7. Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Neutralizing antibody response

  8. Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Neutralizing antibody response

  9. GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154) [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Neutralizing antibody response

  10. SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Binding antibody response

  11. Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Binding antibody response

  12. Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels [ Time Frame: Through Final Visit (365 days after last study vaccine dose) ]
    Binding antibody response


Eligibility Criteria
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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:

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, female, or transgender ≥21 to ≤80 years of age
  6. For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5 months or longer prior to study enrollment

Exclusion Criteria:

Individuals who:

  1. For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)
  2. For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment
  3. Are planning to receive other COVID-19 vaccines during the study period
  4. Recently received other vaccines
  5. Have a fever or are feeling sick close to the time of the first study vaccination
  6. Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection
  7. Are pregnant or breastfeeding
  8. Have had a severe reaction to previous vaccines
  9. Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study
  10. Have some respiratory diseases
  11. Have some significant heart diseases
  12. Have some neurological conditions
  13. Have sickle cell disease or some other blood disorders
  14. Have had a major surgery within the past 6 months
  15. Have a history of chronic liver disease
  16. Have a history of autoimmune disease or immunodeficiency
  17. Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs.
  18. Have received blood products
  19. Have a positive test for hepatitis B or C or human immunodeficiency virus
  20. Have uncontrolled hypertension
  21. Have had cancer except for cancers that were treated and that have low risk of returning
  22. Are obese
  23. Are Investigator site staff members, employees of Arcturus or the contract research organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals
Contacts and Locations
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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): NCT05037097


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

Locations
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United States, Kansas
Arcturus Investigational Site 202 Recruiting
Wichita, Kansas, United States, 67207
Contact    316-689-6635      
United States, Missouri
Arcturus Investigational Site 201 Recruiting
Kansas City, Missouri, United States, 64114
Contact    816-943-0770      
Singapore
Arcturus Investigational Site 101 Recruiting
Singapore, Singapore, 169608
Contact    +65 6323 7532      
Sponsors and Collaborators
Arcturus Therapeutics, Inc.
More Information
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Responsible Party: Arcturus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05037097    
Other Study ID Numbers: ARCT-165-01
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 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
Variants of Concern
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
 Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases