Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
Healthy
About this trial
This is an interventional prevention trial for Healthy focused on measuring Vaccination, Geriatric, Immunology, Influenza
Eligibility Criteria
Inclusion:
- Men and women of age 65 years and older at the time of enrollment
- Eligible to receive Fluzone High-Dose
- Female subjects must be past menopause and not pregnant
- No history of anaphylactic reaction to gelatin, neomycin, or other vaccine component
- Must not have had the flu vaccine within the past 90 days
- Medically stable with no exacerbations or changes in medication regimen for chronic diseases in the past 3 months and no hospitalizations in the past 6 months
- Must be able to read/write English in order to provide informed consent and comply with study procedures
- Expected to be available for the duration of the study
Exclusion:
- Receipt of any other vaccines within the past 30 days prior to enrollment
- Acute illness within the last 7 days
- History of hypersensitivity to the flu vaccine or its components (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).
- History of Guillain Barré syndrome (GBS)
- History of bleeding disorders
- Medical contraindication to treatment with vaccine as indicated by a history of autoimmune disease, immune deficiency, or hypersensitivity to other vaccines.
- Unstable major cardiovascular, renal, endocrine, immunological or hepatic disorder
- Systolic blood pressure (SBP) < 110 mmHg or orthostatic hypotension [>20 mmHg fall in SBP or >10 mmHg fall in diastolic blood pressure (DBP) with standing] at the time of screening.
- Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) (within 14 days prior to entolimod administration). Note: Subjects with localized fungal infections of skin or nails are eligible.
- Clinical signs of febrile illness (temperature >99.5oF)
- Baseline vital signs with ≥Grade 2 abnormalities
Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism, venous thromboembolism) within 6 months prior to study drug administration; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
o Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation, 2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, or Grade ≥2 bradycardia (within 14 days prior to entolimod administration).
Inadequate hepatic function (within 14 days prior to entolimod administration):
- Serum alanine aminotransferase (ALT) ≥3 × upper limit of normal (ULN) (Grade ≥1).
- Serum aspartate aminotransferase (AST) ≥3 × ULN (Grade ≥1)
- Serum alkaline phosphatase (ALP) ≥5 × ULN (Grade ≥2)
- Serum bilirubin ≥1.5 × ULN (Grade ≥1)
Positive antiviral serology:
- Positive hepatitis C virus (HCV) antibody or positive HCV ribonucleic acid (RNA) by quantitative PCR.
- Positive hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing.
- Positive human immunodeficiency virus (HIV) antibody.
- Use of medication that might interact with the flu vaccine including (but not limited to) specifically: aminopyrine, phenytoin sodium, theophylline, and warfarin sodium.
- Any ongoing treatment with immunosuppressive or immune-stimulant therapy
- Ongoing use of systemic corticosteroids.
- Blood or blood products given within the three months prior to vaccination and two months after vaccination
- Current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months]
- Receipt of another investigational pharmaceutical product within 60 days of treatment
- Diagnosis of Parkinson's Disease, previous stroke, or significant cognitive impairment (defined as MMSE <20)
- Other concerns that in the opinion of the PI would preclude a subject from participating in study procedures or from completing the study.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Entolimod 1 mcg
Entolimod 3 mcg
Entolimod 10 mcg
Placebo
Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)
Subjects will receive entolimod as a single dose administered intramuscularly (3mcg)
Subjects will receive entolimod as a single dose administered intramuscularly (10mcg)
Subjects will receive a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.