Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

NCT ID: NCT04176133

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2022-03-30

Brief 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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Entolimod 1 mcg

Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)

Group Type: EXPERIMENTAL

Entolimod

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.

Influenza vaccine

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Entolimod 3 mcg

Subjects will receive entolimod as a single dose administered intramuscularly (3mcg)

Group Type: EXPERIMENTAL

Entolimod

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.

Influenza vaccine

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Entolimod 10 mcg

Subjects will receive entolimod as a single dose administered intramuscularly (10mcg)

Group Type: EXPERIMENTAL

Entolimod

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.

Influenza vaccine

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Influenza vaccine

Intervention Type: DRUG

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Interventions

Entolimod

Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Influenza vaccine

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Intervention Type: DRUG

Other Intervention Names

CBLB502; Fluzone

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genome Protection, Inc.

INDUSTRY

Sponsor Role: collaborator

Robert J. Pignolo

OTHER

Sponsor Role: lead

Responsible Party

Robert J. Pignolo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Pignolo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-004847

Identifier Type: -

Identifier Source: org_study_id