safety, tolerability, and immunogenicity of val-506440 in healthy adult subjects

Conditions: Influenza

Summary: 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

Keywords: val-506440 h10n8 antigen mrna influenza vaccine