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HealthyPhase 2NCT04176133

Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

A Phase 2 study testing Entolimod and Influenza vaccine in people with Healthy, run by Robert J. Pignolo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Entolimod and Influenza vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteUnited States
Study dates
30 Oct 2019to 30 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Administration, Dose-Escalation Study of Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

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
Being tested
Entolimod, Placebo, Influenza vaccine
Keywords
Vaccination, Geriatric, Immunology, Influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntolimodDrug

    Also called CBLB502

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

  • PlaceboDrug

    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 vaccineDrug

    Also called Fluzone

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

Study groups in NCT04176133
Study groupRoleWhat they receive
Entolimod 1 mcgExperimentalSubjects will receive entolimod as a single dose administered intramuscularly (1mcg)
Receives: Drug: Entolimod; Drug: Influenza vaccine
Entolimod 3 mcgExperimentalSubjects will receive entolimod as a single dose administered intramuscularly (3mcg)
Receives: Drug: Entolimod; Drug: Influenza vaccine
Entolimod 10 mcgExperimentalSubjects will receive entolimod as a single dose administered intramuscularly (10mcg)
Receives: Drug: Entolimod; Drug: Influenza vaccine
PlaceboPlacebo comparatorSubjects 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.
Receives: Drug: Placebo; Drug: Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1 month

  2. 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.

    Measured: Baseline, 1 month

  3. 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..

    Measured: Baseline, 1 month

  4. 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

    Measured: 1 year

Secondary outcomes (6)

  1. Time of Onset for Upper-respiratory Infections

    Subject self-reporting of the number of days to develop an upper-respiratory infection

    Measured: 1 year

  2. Upper Respiratory Infections

    The total number of subjects to self-report an upper-respiratory infection

    Measured: 1 year

  3. Change in Frailty

    Change in self-reported 5 items frail scale. Frail scale scores range from 0-5, 1 point for each component, 0 = best 5 = worst (robust=0 points; pre-frail=0-1 points; frail 3-5 points)

    Measured: baseline, 2 months

  4. Change in 6-minute Walk Test

    Distance a subject is able to walk over 6 minutes over a hard flat surface

    Measured: baseline, 2 months

  5. Change in Grip Strength

    Measured by a grip dynamometer as reported in units of pounds.

    Measured: baseline, 2 months

  6. Change in Body Mass Index (BMI)

    Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)

    Measured: baseline, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start30 Oct 2019
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176133
Sponsor's protocol ID
19-004847
Status last verified
May 2023
First submitted
30 Oct 2019
Last updated
22 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Entolimod and Influenza vaccine in people with Healthy, run by Robert J. Pignolo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anti- A/H1N1 Antibody Titer (time frame: Baseline, 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04176133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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