Status:
COMPLETED
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Seasonal Influenza
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to preve...
Detailed Description
Design: This was a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must have met 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
- Part A: Received at least one licensed influenza vaccine from 2016 through the 2019-2020 influenza season
- Part B: Received at least one licensed influenza vaccine from 2017 through the 2022-2023 influenza season
- Able and willing to complete the informed consent process
- Available for clinic visits for 40 weeks after enrollment and through an 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
- 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
- EXCLUSION CRITERIA:
- Participant was excluded if one or more of the following conditions applied:
- Breast-feeding or planning to become pregnant during the study
- Participant 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
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- Previous investigational H1, H2, or H10 influenza vaccines, including Part A participants
- Part A:
- Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season's licensed influenza vaccine at any time prior to enrollment
- Groups 1B, 2B, and 3B only: Receipt of the 2020-2021 season's licensed influenza vaccine within 4 months prior to enrollment.
- Part B and C:
- Groups 4A and 5A only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment
- Groups 4B and 5B only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine within 4 months prior to enrollment.
- Participant had a history of any of the following clinically significant conditions:
- Serious reactions to vaccines that preclude receipt of the study vaccination 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, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
Exclusion
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04896086
Start Date
May 24 2021
End Date
January 25 2024
Last Update
April 27 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892