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Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176133
Recruitment Status : Completed
First Posted : November 25, 2019
Last Update Posted : May 3, 2022
Sponsor:
Collaborator:
Genome Protection, Inc
Information provided by (Responsible Party):
Robert J. Pignolo, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: Entolimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Administration, Dose-Escalation Study of Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
Actual Study Start Date : October 30, 2019
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Dose Level 1
Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)
Drug: Entolimod
Single dose administration of Entolimod
Other Name: CBLB502

Experimental: Dose Level 2
Subjects will receive entolimod as a single dose administered intramuscularly (3mcg)
Drug: Entolimod
Single dose administration of Entolimod
Other Name: CBLB502

Experimental: Dose Level 3
Subjects will receive entolimod as a single dose administered intramuscularly (10mcg)
Drug: Entolimod
Single dose administration of Entolimod
Other Name: CBLB502

Placebo Comparator: 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.
Drug: Placebo
Single dose administration, no active ingredient




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: Baseline, day 1, day 7, 1 month, 2 months, 6 months, 12 months ]
    Changes of the anti- A/H1N1, anti-A/H3N2, and anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: All onsite and phone assessments throughout the study duration, an average of 1 year ]
    All adverse events (AEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176133


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Genome Protection, Inc
Investigators
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Principal Investigator: Robert Pignolo, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: Robert J. Pignolo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04176133    
Other Study ID Numbers: 19-004847
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert J. Pignolo, Mayo Clinic:
Vaccination
Geriatric
Immunology
Influenza
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases