Status:
COMPLETED
Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may ...
Detailed Description
Study Design: This was a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF099-00-VP in two regimens. The hypotheses were that the ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy adults between the ages of 18-70 years inclusive
- Based on history and examination, in good general health and without history of any of the conditions listed in the exclusion criteria
- Received at least one licensed influenza vaccine from 2014 to the present
- Able and willing to complete the informed consent process
- If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and through an influenza season
- If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after enrollment and through an influenza season
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
- 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) less than or equal to 40 within the 28 days before enrollment
- Laboratory Criteria within 28 days before enrollment
- White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
- Total lymphocyte count greater than or equal to 800 cells/mm\^3
- Platelets = 125,000 - 500,000/mm3
- Hemoglobin within institutional normal range
- Serum iron either within institutional normal range or accompanied by the site PI or designee approval
- Serum ferritin within institutional normal range or accompanied by the site PI or designee approval
- Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN
- Alkaline phosphatase (ALP) \<1.1 x institutional ULN
- Total bilirubin within institutional normal range
- Serum creatinine less than or equal to 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
- Agreed to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study
- EXCLUSION CRITERIA:
- 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 planned to receive investigational products while on the study
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
- Current anti-TB (tuberculosis) prophylaxis or therapy
- Previous investigational H1 influenza vaccine
- Previous investigational ferritin-based vaccine
- Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment
- Participant has a history of any of the following clinically significant conditions:
- Serious reactions to vaccines that preclude receipt of 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 (baseline systolic \> 140 mmHg or diastolic \> 90 mmHg)
- 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-Barré 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 :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03814720
Start Date
April 1 2019
End Date
April 6 2021
Last Update
April 29 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892