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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06279871




Registration number
NCT06279871
Ethics application status
Date submitted
23/02/2024
Date registered
28/02/2024
Date last updated
5/06/2024

Titles & IDs
Public title
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults
Scientific title
A Phase 3, Multicenter, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of a Self-Amplifying RNA COVID-19 Vaccine (ARCT-2303), Administered Concomitantly With Quadrivalent Influenza Vaccines, in Adults
Secondary ID [1] 0 0
ARCT-2303-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ARCT-2303
Other interventions - Influenza vaccine
Other interventions - Influenza vaccine, adjuvanted
Other interventions - Placebo

Experimental: Group 1a (ARCT-2303/Influenza vaccine) - Participants will receive one 0.5-mL IM (intramuscular) dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29.

Experimental: Group 2a (ARCT-2303) - Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29.

Active Comparator: Group 3a (Influenza vaccine) - Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29.

Experimental: Group 1b (ARCT-2303/ Influenza vaccine) - Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of influenza vaccine on Day 1 followed by a 0.5-mL IM dose of placebo on Day 29.

Experimental: Group 2b (ARCT-2303) - Participants will receive one 0.5-mL IM dose of ARCT-2303 and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of influenza vaccine on Day 29.

Active Comparator: Group 3b (Influenza vaccine) - Participants will receive one 0.5-mL IM dose of influenza vaccine and one 0.5-mL IM dose of placebo on Day 1 followed by a 0.5-mL IM dose of ARCT-2303 on Day 29.


Other interventions: ARCT-2303
Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5)

Other interventions: Influenza vaccine
Licensed cell-based influenza vaccine

Other interventions: Influenza vaccine, adjuvanted
Licensed influenza vaccine, adjuvanted

Other interventions: Placebo
0.9% saline
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SARS-CoV-2 neutralizing antibody titers
Timepoint [1] 0 0
Day 29
Primary outcome [2] 0 0
SARS-CoV-2 neutralizing antibody seroconversion rates
Timepoint [2] 0 0
Day 29
Primary outcome [3] 0 0
Hemagglutination Inhibition (HI) titers
Timepoint [3] 0 0
Day 1, Day 29
Primary outcome [4] 0 0
SARS-CoV-2 neutralizing antibody titers
Timepoint [4] 0 0
Day 29
Secondary outcome [1] 0 0
SARS-CoV-2 neutralizing antibody titers
Timepoint [1] 0 0
Day 29
Secondary outcome [2] 0 0
SARS-CoV-2 neutralizing antibody seroconversion rates
Timepoint [2] 0 0
Day 29
Secondary outcome [3] 0 0
SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a)
Timepoint [3] 0 0
Days 1, 29 and 181
Secondary outcome [4] 0 0
Hemagglutination Inhibition (HI) titers
Timepoint [4] 0 0
Day 1, Day 29
Secondary outcome [5] 0 0
SARS-CoV-2 neutralizing antibody responses
Timepoint [5] 0 0
Day 181
Secondary outcome [6] 0 0
Hemagglutination Inhibition (HI) assay titers
Timepoint [6] 0 0
Day 29
Secondary outcome [7] 0 0
Local and systemic adverse events (AEs)
Timepoint [7] 0 0
Day 1 to Day 8 after each vaccination
Secondary outcome [8] 0 0
Unsolicited AEs
Timepoint [8] 0 0
Day 1 to Day 29 after each vaccination
Secondary outcome [9] 0 0
SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination
Timepoint [9] 0 0
Day 1 to Day 181

Eligibility
Key inclusion criteria
1, Individuals are male, female, or transgender adults =18 years of age.

2. Healthy participants or participants with pre-existing stable medical conditions.

3. Participant or legally authorized representatives must freely provide documented
informed consent prior to study procedures being performed.

4. Individuals must have been previously vaccinated with COVID-19 vaccines.

5. Individuals of childbearing potential must be willing to adhere to contraceptive
requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals with acute medical illness or febrile illness.

2. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening.

3. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection
within the past 5 months or history of COVID-19 with ongoing sequelae.

4. Individuals with a known history of severe hypersensitivity reactions, including
anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine,
or influenza vaccine, including egg protein.

5. Individuals who have a positive pregnancy test at the Screening visit or who intend to
become pregnant or breastfeed during the study.

6. Individuals with a history of myocarditis, pericarditis, myopericarditis or
cardiomyopathy.

7. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or
transverse myelitis.

8. Individuals with a history of congenital or acquired immunodeficiency.

9. Individuals who have received immunomodulatory, immunostimulatory, or
immunosuppressant drugs within 3 months of Screening; or individuals requiring
systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for =10 days
within 30 days of Screening.

10. Individuals who have received immunoglobulins and/or any blood or blood products
within the 3 months before the first vaccine administration or plan to receive such
products at any time during the study.

11. Individuals with a documented history of HIV infection, or who are currently known to
have active tuberculosis.

12. Individuals receiving treatment with another investigational drug, biological agent,
or device.

13. Individuals who have received any investigational COVID-19 vaccines.

14. Individuals who received any influenza vaccine within 6 months prior to enrollment or
plan to receive an influenza vaccine during the study period.

15. Individuals who have received any other licensed vaccines within 14 days prior to
enrollment in this study or who are planning to receive any vaccine up to 14 days
after the study vaccination.

16. Individuals who are investigator site staff members, employees of the Sponsor or the
Clinical Research Organization 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
1680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Canberra - Canberra
Recruitment hospital [2] 0 0
Paratus Clinical Central Coast - Central Coast
Recruitment hospital [3] 0 0
Sutherland Shire Clinical Research - Walski - Miranda
Recruitment hospital [4] 0 0
Australian Clinical Research Network (ACRN) - Sydney
Recruitment hospital [5] 0 0
Austrials - St. Leonards - Sydney
Recruitment hospital [6] 0 0
Emeritus Research Sydney - Sydney
Recruitment hospital [7] 0 0
Griffith University Clinical Trials Unit - Sydney
Recruitment hospital [8] 0 0
Northern Beaches Clinical Research - Walski - Sydney
Recruitment hospital [9] 0 0
Paratus Clinical Blacktown - Sydney
Recruitment hospital [10] 0 0
Wollongong Clinical Research - Wollongong
Recruitment hospital [11] 0 0
Nucleus Network Brisbane (Q-Pharm) - Brisbane
Recruitment hospital [12] 0 0
Paratus Clinical Brisbane - Brisbane
Recruitment hospital [13] 0 0
USC Southbank - Brisbane
Recruitment hospital [14] 0 0
USC Morayfield - Morayfield
Recruitment hospital [15] 0 0
USC Sippy Down - Sunshine Coast
Recruitment hospital [16] 0 0
CMAX - Adelaide
Recruitment hospital [17] 0 0
Austrials -Sunshine - Melbourne
Recruitment hospital [18] 0 0
Emeritus Research Melbourne - Melbourne
Recruitment hospital [19] 0 0
Nucleus Network - Melbourne
Recruitment hospital [20] 0 0
The Peter Doherty Institute for Infection and Immunity - Melbourne
Recruitment hospital [21] 0 0
Veritus Research - Melbourne
Recruitment hospital [22] 0 0
Clinitrials - Mount Site - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Central Coast
Recruitment postcode(s) [3] 0 0
- Miranda
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Morayfield
Recruitment postcode(s) [8] 0 0
- Sunshine Coast
Recruitment postcode(s) [9] 0 0
- Adelaide
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Costa Rica
State/province [1] 0 0
San Jose
Country [2] 0 0
Costa Rica
State/province [2] 0 0
San José
Country [3] 0 0
Honduras
State/province [3] 0 0
Comayagua
Country [4] 0 0
Honduras
State/province [4] 0 0
San Pedro Sula
Country [5] 0 0
Honduras
State/province [5] 0 0
Tegucigalpa
Country [6] 0 0
Philippines
State/province [6] 0 0
Muntinlupa City
Country [7] 0 0
Philippines
State/province [7] 0 0
Quezon City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arcturus Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Seqirus
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Novotech (Australia) Pty Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the
immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19
vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or
standalone in adults who previously received authorized COVID-19 vaccine.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06279871
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Program Director
Address 0 0
Arcturus Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Disclosure Manager
Address 0 0
Country 0 0
Phone 0 0
(858) 900-2660
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06279871