Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects

NCT04480957 | Completed Phase 1

• 1 other identifier: ARCT-021-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Incidence, severity and dose-relationship of AEs

  Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose

  56 days

Secondary Outcomes (3)

• Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody

  Up to 56 days

• Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels

  Up to 56 days

• Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels

  Up to 56 days

Other Outcomes (5)

• Increase in SARS-CoV-2--spike protein-specific binding antibody levels

  Up to 56 days

• Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre

  Up to 56 days

• Mean SARS-CoV-2--spike protein-specific binding antibody titre

  Up to 56 days

Study Arms (8)

Escalation Cohort dose 1 of ARCT-021, 21 - 55 years

EXPERIMENTAL

Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose 1; Other: Placebo

Escalation Cohort dose 2 of ARCT-021, 21 -55 years

EXPERIMENTAL

Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose 2; Other: Placebo

Escalation Cohort dose 3 of ARCT-021, 21 - 55 years

EXPERIMENTAL

Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose 3; Other: Placebo

Escalation Cohort dose 4 of ARCT-021, 21 - 55 years

EXPERIMENTAL

Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose 4; Other: Placebo

Expansion cohort dose regimen 1, 21 - 55 years.

EXPERIMENTAL

Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose Regimen 1; Other: Placebo

Expansion cohort dose regimen 2, 21 - 55 years.

EXPERIMENTAL

Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose Regimen 2; Other: Placebo

Expansion cohort dose regimen 1, 56 - 80 years

EXPERIMENTAL

Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose Regimen 1; Other: Placebo

Expansion cohort dose regimen 2, 56 - 80 years

EXPERIMENTAL

Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.

Biological: ARCT-021 Dose Regimen 2; Other: Placebo

Interventions

ARCT-021 Dose 1 BIOLOGICAL

ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)

Escalation Cohort dose 1 of ARCT-021, 21 - 55 years

ARCT-021 Dose 2 BIOLOGICAL

ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Escalation Cohort dose 2 of ARCT-021, 21 -55 years

ARCT-021 Dose 3 BIOLOGICAL

ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Escalation Cohort dose 3 of ARCT-021, 21 - 55 years

ARCT-021 Dose 4 BIOLOGICAL

ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Escalation Cohort dose 4 of ARCT-021, 21 - 55 years

ARCT-021 Dose Regimen 1 BIOLOGICAL

ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Expansion cohort dose regimen 1, 21 - 55 years.; Expansion cohort dose regimen 1, 56 - 80 years

ARCT-021 Dose Regimen 2 BIOLOGICAL

ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Expansion cohort dose regimen 2, 21 - 55 years.; Expansion cohort dose regimen 2, 56 - 80 years

Placebo OTHER

Sterile 0.9% saline

Escalation Cohort dose 1 of ARCT-021, 21 - 55 years; Escalation Cohort dose 2 of ARCT-021, 21 -55 years; Escalation Cohort dose 3 of ARCT-021, 21 - 55 years; Escalation Cohort dose 4 of ARCT-021, 21 - 55 years; Expansion cohort dose regimen 1, 21 - 55 years.; Expansion cohort dose regimen 1, 56 - 80 years; Expansion cohort dose regimen 2, 21 - 55 years.; Expansion cohort dose regimen 2, 56 - 80 years

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females aged 21 to 80 at the time of informed consent.
• Body Mass Index 18-35 kg/m2, inclusive, at screening
• Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits
• Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1
• Willing and able to comply with protocol-defined procedures and complete all study visits
• Males must be surgically sterile or willing to use adequate contraception; females must be post-menopausal, surgically sterile or willing to use adequate contraception

You may not qualify if:

• Pregnant or breast feeding
• Clinically significant abnormalities in medical history
• Out of range screening laboratory results
• Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
• Uncontrolled hypertension (BP \> 160/100 mm Hg)
• Uncontrolled diabetes
• Any history of autoimmune disease
• Immunodeficiency of any cause
• History of Chronic liver disease
• Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
• Recent (within 1 year) history of, or current drug or alcohol abuse
• Has any blood dyscrasias or significant disorder of coagulation
• Has an acute illness, as determined by the investigator, with or without fever \[temperature \>38.0 degrees Celsius (100.4 degrees Fahrenheit)\] within 72 hours prior to each vaccination
• Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
• Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.

Sponsors & Collaborators

• Arcturus Therapeutics, Inc.: lead

Study Sites (1)

SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital

Singapore, 169608, Singapore

Location

Study Officials

• Jenny Low Guek Hong, MD

  SingHealth Investigational Medicine Unit (IMU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: August 4, 2020
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

SG (1)