Clinical trial NCT04480957: Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
Official title: A Phase 1/2 Randomised, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Immunogenicity of ARCT-021 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2
Lead sponsor: Arcturus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled, adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult subjects. 0.9% sterile saline will serve as a placebo control. Study drug (ARCT-021 or control) will be administered as an intramuscular (IM) injection. The study comprises two parts. In the Phase 1 part escalating dose levels given as a single injection to younger adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to 55 years) and in two elderly subject (56 to 80 years) cohorts.

Eligibility criteria: Inclusion Criteria:

1. Healthy males or females aged 21 to 80 at the time of informed consent.
2. Body Mass Index 18-35 kg/m2, inclusive, at screening
3. 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
4. Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1
5. Willing and able to comply with protocol-defined procedures and complete all study visits
6. Males must be surgically sterile or willing to use adequate contraception; females must be post-menopausal, surgically sterile or willing to use adequate contraception

Exclusion Criteria:

1. Pregnant or breast feeding
2. Clinically significant abnormalities in medical history
3. Out of range screening laboratory results
4. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
5. Uncontrolled hypertension (BP \> 160/100 mm Hg)
6. Uncontrolled diabetes
7. Any history of autoimmune disease
8. Immunodeficiency of any cause
9. History of Chronic liver disease
10. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
11. Recent (within 1 year) history of, or current drug or alcohol abuse
12. Has any blood dyscrasias or significant disorder of coagulation
13. 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
14. 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.
15. Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.
16. Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study
17. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study

Primary outcomes:
measure: Incidence, severity and dose-relationship of AEs
timeFrame: 56 days
Secondary outcomes:
measure: Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody
timeFrame: Up to 56 days
measure: Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels
timeFrame: Up to 56 days
measure: Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels
timeFrame: Up to 56 days
Other outcomes:
measure: Increase in SARS-CoV-2--spike protein-specific binding antibody levels
timeFrame: Up to 56 days
measure: Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre
timeFrame: Up to 56 days
measure: Mean SARS-CoV-2--spike protein-specific binding antibody titre
timeFrame: Up to 56 days
measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate
timeFrame: 56 days
measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline)
timeFrame: 56 days
Locations:
city: Singapore
country: Singapore
facility: SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
Study officials:
affiliation: SingHealth Investigational Medicine Unit (IMU)
name: Jenny Low Guek Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: