Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
Condition: Healthy
MeSH terms: Influenza, Human
Intervention: Entolimod; Placebo; Influenza vaccine
Intervention description: Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.; Intramuscular (IM) single dose administration, no active ingredient. A matching placebo is provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.; Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccination; Geriatric; Immunology; Influenza

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) < 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.