Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

FBP00012

This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.

2022-06-09

2024-01-03

2024-01-03

Completed

Early phase I

233

Inclusion Criteria: * Aged 18 years or older on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1. Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR 2. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention. * Informed consent form has been signed and dated. Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration. * Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. * Have any diagnosis, current or past, of autoimmune disease. * Body mass index of 40 kg/m2 or higher. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination. * Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.

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2024-01-31