Influenza
Conditions
Keywords
VAL-339851, H7N9 antigen mRNA, Influenza vaccine, Moderna
Brief summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
Interventions
BIOLOGICALVAL-339851
Escalating dose levels
OTHERPlacebo
Saline
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of solicited AEs (local and systemic reactogenicity events) | 7 days following each dose administration |
| Frequency of unsolicited adverse events | 21 days following each dose administration |
| Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness | One year after last dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample | One year after last dose administration |
| Seroconversion rates in comparison to baseline samples | One year after last dose administration |
Countries
United States
Outcome results
None listed