Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects

This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

Inclusion

• Agrees to comply with the study procedures and provides written informed consent
• 18 to 64 years of age
• Body mass index between 18 and 30 kg/m2
• Negative urine pregnancy test at the Screening visit and the day of each vaccination.
• Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination
• In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination

Exclusion

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
• Administration of an investigational product within 45 days
• Women who are pregnant or breastfeeding, or plan to become pregnant during the study
• Prior administration of investigational agent using formulations similar to VAL-506440
• History of a serious reaction to prior influenza vaccinations
• History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
• Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period
• Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination
• Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
• Any acute disease at the time of enrollment
• Any bleeding risk or thromboembolic event or any related medical history
• Regular alcohol consumption > 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening
• Persons employed in a capacity that involves handling poultry or wild birds
• Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study
• Had major surgery or donation of blood or blood products within 4 weeks of dosing
• Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening
• Subject is an employee of the Sponsor or CRO involved in the study.
• Vulnerable subjects (e.g., a subject kept in detention).
• Any condition, that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of the study results
• History of autoimmune disease
• Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin > 1.5xULN
• Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine