Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

NCT04176133 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-004847
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Vaccination; Geriatric; Immunology; Influenza

Outcome Measures

Primary Outcomes (4)

• Change in Anti- A/H1N1 Antibody Titer

  Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.

  Baseline, 1 month

• Change in Anti-A/H3N2 Antibody Titer

  Change of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.

  Baseline, 1 month

• Change in Anti-B Antibody Titer

  Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month..

  Baseline, 1 month

• Adverse Events

  The number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year

  1 year

Secondary Outcomes (6)

• Time of Onset for Upper-respiratory Infections

  1 year

• Upper Respiratory Infections

  1 year

• Change in Frailty

  baseline, 2 months

• Change in 6-minute Walk Test

  baseline, 2 months

• Change in Grip Strength

  baseline, 2 months

Study Arms (4)

Entolimod 1 mcg

EXPERIMENTAL

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

Drug: Entolimod; Drug: Influenza vaccine

Entolimod 3 mcg

EXPERIMENTAL

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

Drug: Entolimod; Drug: Influenza vaccine

Entolimod 10 mcg

EXPERIMENTAL

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

Drug: Entolimod; Drug: Influenza vaccine

Placebo

PLACEBO COMPARATOR

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; Drug: Influenza vaccine

Interventions

Entolimod DRUG

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

Also known as: CBLB502

Entolimod 1 mcg; Entolimod 10 mcg; Entolimod 3 mcg

Placebo 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.

Placebo

Influenza vaccine DRUG

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

Also known as: Fluzone

Entolimod 1 mcg; Entolimod 10 mcg; Entolimod 3 mcg; Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Robert J. Pignolo: lead
• Genome Protection, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Influenza, Human

Interventions

CBLB502; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Robert J. Pignolo, MD, PhD
• Organization: Mayo Clinic

Pignolo.Robert@mayo.edu

507-255-8716

Study Officials

• Robert Pignolo, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 25, 2019
• Study Start: October 30, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)