Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults
Influenza Infection
About this trial
This is an interventional prevention trial for Influenza Infection focused on measuring Flu, Seasonal Allergy, Respiratory Illness, Flu Virus, Viral Infection
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1: H1ssF_3928 (20 mcg), ages 18-40 years
Group 2A: H1ssF_3928 (60 mcg), ages 18-40 years
Group 2B: H1ssF_3928 (60 mcg), ages 41-49 years
Group 2C: H1ssF_3928 (60 mcg), ages 50-59 years
Group 2D: H1ssF_3928 (60 mcg), ages 60-70 years
H1ssF_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)
H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
H1ssF_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)