safety, tolerability, and immunogenicity of val-339851 in healthy adult subjects

Conditions: Influenza

Summary: this clinical study will assess the safety, tolerability and immunogenicity of val-339851 in healthy subjects.


Eligibility criteria:
inclusion criteria: * agrees to comply with the study procedures and provides written informed consent * 18 to 49 years of age * body mass index between 18 and 35 kg/m2 * negative urine pregnancy test at the screening visit and the day of each vaccination for females of childbearing potential. * female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 3 weeks prior to enrollment and through the end of study visit * in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination * has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study exclusion criteria: * any ongoing, symptomatic acute or chronic illness requiring medical or surgical care * administration of another investigational product within 60 days, or 5 half-lives, whichever is longer * participation in an investigational study involving lipid nanoparticles * a history of hypersensitivity or serious reactions to previous influenza vaccinations * history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine * history of narcolepsy * administration of any licensed (inactivated or live) vaccines within 4 weeks before enrollment or plans to receive any vaccine within 12 weeks of the last study drug administration; receipt of any other avian h7n9 influenza vaccine at any time prior to or during the study is exclusionary * 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 significant disorder of coagulation requiring ongoing or intermittent treatment * active neoplastic disease or a history of any hematologic malignancy * history of alcohol abuse or drug addiction within 1 year before the planned day of dose administration * a positive test result for drugs of abuse or alcohol at screening or before the first dose administration * persons employed in a capacity that involves handling poultry or wild birds. * the subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site * 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 * a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening * donation of blood or blood products \> 450 ml within 30 days of dosing

Keywords: val-339851 h7n9 antigen mrna influenza vaccine moderna