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

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ARCT-165

ARCT-154

ARCT-021

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2 Vaccine, Coronavirus Virus Diseases, RNA COVID-19, COVID-19 Vaccine Arcturus, Self Amplifying RNA Vaccine, Variants of Concern

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals who:

Are able to provide consent
Agree to comply with all study visits and procedures
Are willing and able to adhere to study restrictions
Are sexually active and willing to adhere to contraceptive requirements
Are male, female, or transgender ≥21 to ≤80 years of age
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:

For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)
For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment
Are planning to receive other COVID-19 vaccines during the study period
Recently received other vaccines
Have a fever or are feeling sick close to the time of the first study vaccination
Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection
Are pregnant or breastfeeding
Have had a severe reaction to previous vaccines
Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study
Have some respiratory diseases
Have some significant heart diseases
Have some neurological conditions
Have sickle cell disease or some other blood disorders
Have had a major surgery within the past 6 months
Have a history of chronic liver disease
Have a history of autoimmune disease or immunodeficiency
Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs.
Have received blood products
Have a positive test for hepatitis B or C or human immunodeficiency virus
Have uncontrolled hypertension
Have had cancer except for cancers that were treated and that have low risk of returning
Are obese
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

Sites / Locations

Arcturus Investigational Site 202Recruiting
Arcturus Investigational Site 201Recruiting
Arcturus Investigational Site 101Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Study Group 1, Adult Participants Not Previously Vaccinated randomized to receive ARCT-165

Study Group 2, Adult Participants Not Previously Vaccinated randomized to receive ARCT-154

Study Group 3, Adult Participants Not Previously Vaccinated to receive ARCT-021

Study Group 4, Adult Participants Previously Vaccinated randomized to receive ARCT-165

Study Group 5, Adult Participants Previously Vaccinated randomized to receive ARCT-154

Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-021

Arm Description

Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

Participants will receive one dose of ARCT-165 on Day 1

Participants will receive one dose of ARCT-154 on Day 1

Participants will receive one dose of ARCT-021 on Day 1

Outcomes

Primary Outcome Measures

Percentage of participants reporting solicited local or systemic adverse events

Solicited adverse events reported daily in a diary that reflect generalized symptoms or findings at the injection site following each vaccination

Percentage of participants reporting unsolicited adverse events

Spontaneously reported adverse events

Percentage of participants reporting medically attended adverse events

Medically attended adverse event is an AE that leads to an unscheduled visit with a health care provider

Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal

Unsolicited adverse events that meet stopping rules

Percentage of participants reporting serious adverse events

Unsolicited adverse events that meet the definition of serious

SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

Neutralizing antibody response

Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs

Neutralizing antibody response

Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

Neutralizing antibody response

GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154)

Neutralizing antibody response

SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs

Binding antibody response

Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs

Binding antibody response

Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels

Binding antibody response

Secondary Outcome Measures

Full Information

NCT ID

NCT05037097

First Posted

August 30, 2021

Last Updated

November 10, 2021

Sponsor

Arcturus Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05037097

Brief Title

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

Official Title

A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 30, 2021 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arcturus Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

The study will initially enroll approximately 72 adult participants into 2 cohorts and may expand enrollment up to 144 participants if additional cohorts are added. The first cohort (Cohort A) will include a total of 36 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

SARS-CoV-2 Vaccine, Coronavirus Virus Diseases, RNA COVID-19, COVID-19 Vaccine Arcturus, Self Amplifying RNA Vaccine, Variants of Concern

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

The study will evaluate 3 investigational vaccines in parallel.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Observer Blind

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Group 1, Adult Participants Not Previously Vaccinated randomized to receive ARCT-165

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29

Arm Title

Study Group 2, Adult Participants Not Previously Vaccinated randomized to receive ARCT-154

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29

Arm Title

Study Group 3, Adult Participants Not Previously Vaccinated to receive ARCT-021

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29

Arm Title

Study Group 4, Adult Participants Previously Vaccinated randomized to receive ARCT-165

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-165 on Day 1

Arm Title

Study Group 5, Adult Participants Previously Vaccinated randomized to receive ARCT-154

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-154 on Day 1

Arm Title

Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-021

Arm Type

Experimental

Arm Description

Participants will receive one dose of ARCT-021 on Day 1

Intervention Type

Biological

Intervention Name(s)

ARCT-165

Intervention Description

Dose 3

Intervention Type

Biological

Intervention Name(s)

ARCT-154

Intervention Description

Dose 2

Intervention Type

Biological

Intervention Name(s)

ARCT-021

Intervention Description

Dose 1

Primary Outcome Measure Information:

Title

Percentage of participants reporting solicited local or systemic adverse events

Description

Solicited adverse events reported daily in a diary that reflect generalized symptoms or findings at the injection site following each vaccination

Time Frame

For 7 days following each study vaccination

Title

Percentage of participants reporting unsolicited adverse events

Description

Spontaneously reported adverse events

Time Frame

For 28 days following each study vaccination

Title

Percentage of participants reporting medically attended adverse events

Description

Medically attended adverse event is an AE that leads to an unscheduled visit with a health care provider

Time Frame