Trials Today

Condition

• Healthy

Eligibility

Eligible Ages

Over 65 Years

Eligible Genders

All

Accepts Healthy Volunteers

Yes

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.