Status:
ACTIVE_NOT_RECRUITING
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
Lead Sponsor:
Arcturus Therapeutics, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Influenza, Human
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives...
Detailed Description
Phase 1, first-in-human, randomized, controlled, observer blind, dose level and schedule-finding study, to evaluate the safety, reactogenicity, and immunogenicity of a self-amplifying mRNA pandemic in...
Eligibility Criteria
Inclusion
- Main
- Individuals are male or female adults 18-80 years of age.
- Healthy participants or participants with pre-existing stable medical conditions.
- Individuals of childbearing potential must be willing to adhere to contraceptive requirements.
- Main
Exclusion
- Individuals with acute medical conditions or febrile illness, including body temperature ≥100.4°F (≥38.0°C measured by any method) within 3 days prior to randomization.
- 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.
Key Trial Info
Start Date :
December 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06602531
Start Date
December 10 2024
End Date
December 19 2025
Last Update
October 21 2025
Active Locations (4)
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1
Velocity Clinical Research
La Mesa, California, United States, 91942
2
Velocity Clinical Research
San Bernardino, California, United States, 92408
3
Tekton Research
Longmont, Colorado, United States, 80501
4
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212