SARS-CoV-2
Conditions
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.
Interventions
BIOLOGICALARCT-021 Dose 1
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)
BIOLOGICALARCT-021 Dose 2
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
BIOLOGICALARCT-021 Dose 3
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
BIOLOGICALARCT-021 Dose 4
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
BIOLOGICALARCT-021 Dose Regimen 1
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
BIOLOGICALARCT-021 Dose Regimen 2
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
OTHERPlacebo
Sterile 0.9% saline
Sponsors
Arcturus Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity and dose-relationship of AEs | 56 days | Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody | Up to 56 days | SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT |
| Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels | Up to 56 days | SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer |
| Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels | Up to 56 days | GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point |
Other
| Measure | Time frame | Description |
|---|---|---|
| Increase in SARS-CoV-2--spike protein-specific binding antibody levels | Up to 56 days | GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point |
| SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline) | 56 days | Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels |
| Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre | Up to 56 days | GMT for SARS-CoV-2--spike protein-specific binding antibody levels |
| Mean SARS-CoV-2--spike protein-specific binding antibody titre | Up to 56 days | Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels |
| SARS-CoV-2-specific serum neutralizing antibody seroconversion rate | 56 days | Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies |
Countries
Singapore
Outcome results
None listed