Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults

Launched by ARCTURUS THERAPEUTICS, INC. · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of influenza vaccine called ARCT-2304, which uses a self-amplifying RNA technology. The main aim is to determine how safe this vaccine is and how well it can trigger an immune response in adults. Participants will receive either two doses of the ARCT-2304 vaccine or one dose of a standard licensed influenza vaccine along with a placebo (a harmless substance). The researchers want to find the best dose that keeps people safe while also building immunity against the flu.

To participate in the study, individuals need to be between 18 and 80 years old and in good health, or have stable medical conditions. Participants must also be willing to follow specific guidelines, like keeping a daily diary about how they feel for a week after each shot and providing blood samples at clinics. It’s important to note that people with certain health issues or recent vaccinations may not be eligible. Overall, this trial is an important step in developing a potentially effective vaccine for preventing flu outbreaks.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 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 Criteria:
• • 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.