entolimod on immunosenescence in healthy geriatric subjects receiving influenza vaccination

Conditions: Healthy

Summary: researchers are evaluating the safety and effectiveness of a single administration of entolimod when administered at the same time as the influenza vaccine (flu vaccine).


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) \ 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.

Keywords: vaccination geriatric immunology influenza