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

SARS-CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480957
• Other study ID #: ARCT-021-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 4, 2020
• Est. completion date: January 29, 2021

Study information

• Verified date: August 2021
• Source: Arcturus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• ARCT-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)
• ARCT-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
• ARCT-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
• ARCT-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
• ARCT-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
• ARCT-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

Other:
• Placebo
Sterile 0.9% saline

Locations

Country	Name	City	State
Singapore	SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Arcturus Therapeutics, Inc.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Increase in SARS-CoV-2--spike protein-specific binding antibody levels	GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point	Up to 56 days
Other	Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre	GMT for SARS-CoV-2--spike protein-specific binding antibody levels	Up to 56 days
Other	Mean SARS-CoV-2--spike protein-specific binding antibody titre	Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels	Up to 56 days
Other	SARS-CoV-2-specific serum neutralizing antibody seroconversion rate	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	56 days
Other	SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline)	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	56 days
Primary	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	Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody	SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT	Up to 56 days
Secondary	Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels	SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer	Up to 56 days
Secondary	Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels	GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point	Up to 56 days