Study Investigating New mRNA Vaccine Formulations for Bird Flu

About the Study

This Phase 1 clinical study is evaluating investigational mRNA vaccines made with different formulations called lipid nanoparticles (LNPs).

Researchers are testing these new formulations because early studies suggest they may help improve how well future mRNA vaccines work, how stable they are, and how they are tolerated.

The purpose of this study is to:

Assess the safety of different investigational vaccine formulations

Measure immune responses through blood testing

Support development of improved mRNA vaccines for influenza (Bird Flu)

Who is it for?

• You are 18 to 49 years old
• You are generally healthy
• You are not pregnant or breastfeeding
• You are willing to attend all required clinic visits and phone follow-ups
• You are willing to receive an investigational vaccine injection
• You are willing to self-administer a once-weekly injection
• You are using reliable contraception (if applicable)

What to Expect During Study Participation

If you are eligible, you will take part in the study for up to approximately 7 months. This includes screening, vaccination(s), clinic visits, and follow-up phone calls.

Participants will receive an investigational mRNA vaccine by intramuscular injection (given into the muscle of the upper arm). Participants will receive two doses administered 3 weeks apart.

Throughout the study, doctors and nurses will closely monitor your health and wellbeing through regular check-ups, blood tests, and safety assessments. These visits help researchers understand how the different vaccine formulations are tolerated and how the immune system responds over time.

Study procedures may include medical history collection, physical examinations, vital signs monitoring, ECGs (heart monitoring), blood tests to measure immune response, pregnancy testing, and diary reporting of any symptoms following vaccination. Follow-up phone calls will also take place later in the study to check on your health.

Before enrolling, the study doctor and clinical team will explain the study in detail, including potential risks and benefits, what participation involves, and any questions you may have.

Eligible participants will be compensated for study-related time and travel.