Ocena dawki, bezpieczeństwa, tolerancji i immunogenności mozaiki sześciowartościowej szczepionki przeciw grypie VRCFLUMOS0116-00-VP (Flumos-V2) z i bez uzupełniającego ALFQ u zdrowych dorosłych dorosłych

• INCLUSION CRITERIA:

• A participant must meet all of the following criteria:

  • Healthy adults between the ages of 18-50 years, inclusive
  • Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the exclusion criteria
  • Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season
  • Able and willing to complete the informed consent process
  • Available for clinic visits for 68 weeks after enrollment, including through the 2025-2026 influenza season
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  • Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) <= 35 within the 56 days before enrollment
  • Agrees to not receive the 2025-2026 licensed influenza vaccination during study participation due to potential confounding of study results
  • Willing to have blood and mucosal samples collected, stored indefinitely, and used for research purposes

• Laboratory Criteria within 56 days before enrollment

  • White blood cells (WBC) and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee
  • Total lymphocyte count >= 800 cells/microL
  • Platelets = 125,000 - 400,000 cells/microL
  • Hemoglobin within institutional normal range or accompanied by approval of the PI or designee
  • Alanine aminotransferase (ALT) <= 1.25 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) <= 1.25 x institutional ULN
  • Alkaline phosphatase (ALP) < 1.1 x institutional ULN
  • Total bilirubin within institutional normal range or accompanied by approval of the PI or designee
  • Serum creatinine <= 1.1 x institutional ULN
  • Negative for HIV infection by an FDA-approved method of detection

• Criteria applicable to women of childbearing potential:

  • Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment
  • Agrees to use an effective method of birth control from at least 21 days prior to enrollment through the end of the study.

EXCLUSION CRITERIA:

• A participant will be excluded if one or more of the following conditions apply:

  -- Women who are breast-feeding or planning to become pregnant during the study

• A Participant has received any of the following substances:

  • Receipt of any licensed influenza vaccine within 6 months prior to enrollment.
  • Plan to or are required to receive the 2025-2026 licensed influenza vaccine
  • Live attenuated vaccines within 4 weeks prior to enrollment
  • Inactivated vaccines within 2 weeks prior to enrollment
  • mRNA vaccines within 4 weeks prior to enrollment
  • Receipt of 20 mcg of the influenza vaccine VRC-FLUNPF081-00-VP (HA-F A/Sing, VRC 316, Group 1)
  • Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)
  • Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)
  • More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
  • Blood products within 16 weeks prior to enrollment
  • Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  • Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
  • Current anti-TB prophylaxis or therapy

• Participant has a history of any of the following clinically significant conditions:

  • Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee
  • Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  • Asthma that is not well controlled
  • Diabetes mellitus (type I or II), except for gestational diabetes
  • Thyroid disease that is not well controlled
  • Idiopathic urticaria within the past year
  • Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies
  • Hypertension that is not well controlled
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  • Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  • Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  • Guillain-Barre Syndrome
  • Any medical, social condition, occupational reason, or other reason that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs a participant s ability to give informed consent, including but not limited to clinically significant forms of infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.