A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

Arcturus Therapeutics, Inc.72 enrolled

Overview

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.

The study will initially enroll approximately 72 adult participants into 2 cohorts (A and B). Cohort A is further sub-divided into two sub-cohorts which include 12 participants who are seronegative, not previously vaccinated at screening (Sub-cohort A1) and 24 participants who are seropositive, not previously vaccinated at screening (Sub-cohort A2). Within the first cohort (Cohort A), Sub-cohort A1 will include a total of 12 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Sub-cohort A2 will include a total of 24 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COVID-19 SARS-CoV-2 Infection Corona Virus Infection

Interventions

ARCT-165BIOLOGICAL

Dose 3

ARCT-154BIOLOGICAL

Dose 2

ARCT-021BIOLOGICAL

Dose 1

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Arcturus Investigational Site 202

Wichita, Kansas, United States

Arcturus Investigational Site 201

Kansas City, Missouri, United States

Arcturus Investigational Site 101

Singapore, Singapore

Arcturus Investigational Site 301

Diepkloof, Soweto, South Africa

Outcomes

Primary Outcomes

Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)

Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Time frame: Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)

Number of Participants Reporting Unsolicited AEs

Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Time frame: Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)

Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs)

An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Data from ClinicalTrials.gov

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