Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects

Moderna

Status and phase

Completed

Phase 1

Conditions

Influenza

Treatments

Biological: VAL-339851

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03345043

VAL-339851-P101

Details and patient eligibility

About

This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.

Enrollment

156 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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