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

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


Eligibility Criteria:
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