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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/NCT06125691




Registration number
NCT06125691
Ethics application status
Date submitted
5/11/2023
Date registered
9/11/2023
Date last updated
16/02/2024

Titles & IDs
Public title
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
Scientific title
A Phase 1, First-in-Human, Randomized, Observer-blind, Controlled, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Self-Amplifying mRNA Seasonal Influenza Vaccine (ARCT-2138), When Administered to Healthy Adults
Secondary ID [1] 0 0
ARCT-2138-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ARCT-2138
Other interventions - Licensed Quadrivalent Vaccine for younger adults
Other interventions - Licensed Quadrivalent Vaccine for older adults

Experimental: Cohort 1 of ARCT-2138, younger adults - Dose Level 1 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: Cohort 2 of ARCT-2138, younger adults - Dose Level 2 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: Cohort 3 of ARCT-2138, younger adults - Dose Level 3 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: Cohort 4 of ARCT-2138, younger adults - Dose Level 4 of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: Low Dose, younger and older adults - Low dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: Medium Dose, younger and older adults - Medium dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Experimental: High Dose, younger and older adults - High dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle.
Interventions:
Investigational Vaccine: ARCT-2138

Active Comparator: Control Dose, younger adults - Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle.
Interventions:
Control Vaccine: Licensed Quadrivalent Vaccine for younger adults

Active Comparator: Control Dose, older adults - Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle.
Interventions:
Control Vaccine: Licensed Quadrivalent Vaccine for older adults


Other interventions: ARCT-2138
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

Other interventions: Licensed Quadrivalent Vaccine for younger adults
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

Other interventions: Licensed Quadrivalent Vaccine for older adults
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants reporting local Adverse Events
Timepoint [1] 0 0
14 Days following study vaccination
Primary outcome [2] 0 0
Percentage of participants reporting systemic Adverse Events
Timepoint [2] 0 0
14 Days following study vaccination
Primary outcome [3] 0 0
Percentage of participants reporting unsolicited Adverse Events
Timepoint [3] 0 0
29 Days following study vaccination
Primary outcome [4] 0 0
Percentage of participants reporting laboratory or vital signs abnormalities
Timepoint [4] 0 0
29 Days following study vaccination
Primary outcome [5] 0 0
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Timepoint [5] 0 0
29 Days following study vaccination
Primary outcome [6] 0 0
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
Timepoint [6] 0 0
29 days following study vaccination
Primary outcome [7] 0 0
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
Timepoint [7] 0 0
29 days following study vaccination
Secondary outcome [1] 0 0
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Timepoint [1] 0 0
181 days following study vaccination
Secondary outcome [2] 0 0
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
Timepoint [2] 0 0
181 days following study vaccination
Secondary outcome [3] 0 0
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
Timepoint [3] 0 0
181 days following study vaccination

Eligibility
Key inclusion criteria
1. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85
years of age.

2. Healthy participants or participants with pre-existing stable medical conditions.
Pre-existing stable medical condition means a subject who: has full capacity of daily
activity and no major medication modification; has not undergone surgical or minimally
invasive intervention or had any hospitalization/emergency room visit for the specific
medical condition within 3 months prior to Day 1.

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

4. Individuals who have not received influenza vaccine within 6 months prior to
enrollment.

5. Individuals must agree to comply with all study visits and procedures (including blood
tests, nasopharyngeal swabs, diary completion, receipt of telephone calls from the
site, willingness to be available for Unscheduled Clinic Visits).

6. Individuals of childbearing potential must be willing to adhere to contraceptive
requirements.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals with acute medical illness or febrile illness, including body temperature
>100.4°F (>38.0°C) within 3 days prior to Randomization. These individuals may be
offered the opportunity to enter the study after fever and illness has stabilized.
Participants with suspected or confirmed influenza should be excluded and referred for
medical care. Rescreening will be permitted for individuals who are presented with
suspected influenza if another diagnosis is confirmed.

2. Individuals with any medical, neurological, or psychiatric condition that, in the
opinion of the investigator, could place the participant at an unacceptable risk of
injury or render the participant unable to comply with all study procedures and
achieve successful completion of the trial.

3. Individuals with a known history of severe hypersensitivity reactions, including
anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza
vaccine, or excipients.

4. Individuals who have a positive pregnancy test at the Screening visit or Day 1 or who
intend to become pregnant or breastfeed during the study.

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

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

7. Individuals with a known bleeding disorder that would, in the opinion of the
investigator, contraindicate intramuscular (I.M.) injection.

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

9. Individuals who have received immunomodulatory, immunostimulatory, or
immunosuppressant drugs including interferon and cytotoxic drugs within 3 months of
Screening/Day 1 or who plan to receive them during the study.

10. Individuals requiring systemic corticosteroids exceeding 10 mg/day of prednisone
equivalent for =10 days within 30 days of Screening. The use of topical, ophthalmic,
inhaled, and intranasal steroid preparations will be permitted.

11. 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.

12. Individuals with an immunosuppressive or immunodeficient state, asplenia, or recurrent
severe infections.

13. Individuals with a documented history of chronic infection including HIV, HBV, HCV, or
who are currently known to have active tuberculosis.

14. Individuals with chronic illness that, in the opinion of the Investigator, are at a
stage where it might interfere with trial participation or interpretation of study
results.

15. Individuals receiving treatment with another investigational drug, biological agent,
or device within 28 days of screening, or 5 half-lives of the investigational drug,
whichever is longer; or are currently enrolled in or plan to participate in another
clinical trial with an investigational agent during the study period.

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

17. 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.

18. 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 1
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
22/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Brisbane Clinic - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

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 safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA
Seasonal Influenza Vaccine (ARCT-2138) in adults.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06125691
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
clinicaltrials@arcturusrx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06125691