Status:
COMPLETED
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no sin...
Detailed Description
Design: This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2)...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A subject must meet all of the following criteria:
- Healthy adults between the ages of 18-50 years, inclusive
- Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria
- For Part A: Received at least one licensed influenza vaccine from 2018 through the 2022-2023 influenza season
- Able and willing to complete the informed consent process
- For Part A: Available for clinic visits for 40 weeks after enrollment, including through the 2023-2024 influenza season
- For Part B: Available for clinic visits for 40 weeks after enrollment, including through the 2024-2025 influenza season
- For Part B: Agrees to undergo four lymph node FNAs.
- 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
- For both Parts A and B: Agrees to not receive any licensed influenza vaccine during study participation due to potential confounding of study results
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
- For Part B: Willing to have lymph node 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 the site Principal Investigator (PI) or designee approval
- Total lymphocyte count \>= 800 cells/microliter
- Platelets = 125,000 - 500,000 cells/microliter
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- 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 the PI or designee approval
- 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 means of birth control from at least 21 days prior to enrollment through the end of the study for sample collection.
- EXCLUSION CRITERIA:
- A participant will be excluded if one or more of the following conditions apply:
- Women breast-feeding or planning to become pregnant during the study
- Participant has received any of the following substances:
- 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
- Live attenuated vaccines within 4 weeks prior to enrollment
- Inactivated vaccines within 2 weeks prior to enrollment
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study (Note: SARS-CoV-2 vaccines licensed and/or approved by emergency use authorization are not exclusionary, but are subject to the criteria for timing of inactivated vaccines or mRNA vaccines)
- mRNA vaccines within 4 weeks prior to enrollment
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- Receipt of investigational ferritin-based nanoparticle influenza vaccines, with the exception of participants previously enrolled in the VRC 316 study as follows: Group 2 (HA-F A/Sing prime, HA-F A/Sing boost), 3A (DNA A/Sing prime, HA-F A/Sing boost) or 4A (HA-F A/Sing prime, HA-F A/Sing boost).
- Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1)
- Receipt of any licensed influenza vaccine within 6 months prior to enrollment.
- For Part A: Receipt of the 2023-2024 licensed influenza vaccine
- For Part B: Plan to or are required to receive the 2024-2025 licensed influenza vaccine
- For Part B: Receipt of any licensed seasonal influenza vaccine since the 2022-2023 influenza season; including the 2023-2024 influenza season through the 2024-2025 influenza season.
- Subject 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 investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Autoimmune disease or immunodeficiency
- 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, psychiatric, or social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject 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.
Exclusion
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05968989
Start Date
August 9 2023
End Date
November 1 2025
Last Update
January 6 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892