Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
NCT ID: NCT06602531
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
212 participants
INTERVENTIONAL
2024-12-10
2025-12-05
Brief Summary
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* To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine
* To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition (HAI) and neuraminidase enzyme-linked lectin (ELLA) antibody responses
Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine.
Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo.
They will be asked:
* to complete a daily diary for 7 days after each vaccination, answering questions how they have been feeling on that day.
* to provide blood samples at each visit in the clinic
* to comply with all study visits and procedures (e.g., be available for planned telephone contacts and unscheduled clinic visits, if required)
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Detailed Description
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Study drug (ARCT-2304 or control) will be administered as a 2-dose vaccination series as an intramuscular (IM) injection. The study comprises two parts.
In Part 1, 120 participants (young adults) will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine. Participants will be further randomized to one of the two different vaccination schedules.
In Part 2, 80 participants (older adults) will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine. Participants will be further randomized to one of the two different vaccination schedules.
Investigational Vaccine: ARCT-2304
Control Vaccines: licensed influenza vaccines
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control, Schedule 2, Older Adults
Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine older adult and saline placebo vaccine
Control vaccine older adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Placebo Vaccine
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Low dose of ARCT-2304, Schedule 2, Older Adults
Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Mid dose of ARCT-2304, Schedule 2, Older Adults
Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
High dose of ARCT-2304, Schedule 2, Older Adults
High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Low dose of ARCT-2304, Schedule 1, Young Adults
Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Mid dose of ARCT-2304, Schedule 1, Young Adults
Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
High dose of ARCT-2304, Schedule 1, Young Adults
High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Control, Schedule 1, Young Adults
Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine
Control vaccine younger adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Placebo Vaccine
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Low dose of ARCT-2304, Schedule 1, Older Adults
Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Mid dose of ARCT-2304, Schedule 1, Older Adults
Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
High dose of ARCT-2304, Schedule 1, Older Adults
High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Control, Schedule 1, Older Adults
Older Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 1 Investigational Vaccine: Comparator vaccine older adult and saline
Control vaccine older adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Placebo Vaccine
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Low dose of ARCT-2304, Schedule 2, Young Adults
Low dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Mid dose of ARCT-2304, Schedule 2, Young Adults
Mid dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
High dose of ARCT-2304, Schedule 2, Young Adults
High dose of ARCT-2304 administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: ARCT-2304
ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Control, Schedule 2, Young Adults
Young Adults Control Vaccine (dose 1) and placebo (dose 2) administered through intramuscular injection in the deltoid muscle.
Interventions: 2-dose regimen, schedule 2 Investigational Vaccine: Comparator vaccine younger adult and saline placebo vaccine
Control vaccine younger adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Placebo Vaccine
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Interventions
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ARCT-2304
Each participant will receive 2-dose regimen intramuscular (IM) dose into the deltoid muscle.
Control vaccine younger adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Control vaccine older adults
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Placebo Vaccine
Each participant will receive one intramuscular (IM) dose into the deltoid muscle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy participants or participants with pre-existing stable medical conditions.
* Individuals of childbearing potential must be willing to adhere to contraceptive requirements.
Exclusion Criteria
* Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenza vaccine, or excipients.
* Individuals with a history of myocarditis, pericarditis, myopericarditis, or cardiomyopathy.
* Individuals who received any influenza vaccine within 3 months prior to first vaccine administration or plan to receive an influenza vaccine during the study period.
* Individuals who have received mRNA vaccination within 60 days before the first vaccine administration.
* Individuals who have received or plan to receive an A/H5N1 influenza vaccine and/or individuals who had substantial exposure to or direct contact with poultry, wild birds, live cattle, or raw milk.
18 Years
80 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Arcturus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Program Director
Role: STUDY_DIRECTOR
Arcturus Therapeutics
Locations
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Velocity Clinical Research
La Mesa, California, United States
Velocity Clinical Research
San Bernardino, California, United States
Tekton Research
Longmont, Colorado, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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ARCT-2304-01
Identifier Type: -
Identifier Source: org_study_id
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