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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
61
Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
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.
Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: 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.
Time frame: 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..
Time frame: 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
Time frame: 1 year
Time of Onset for Upper-respiratory Infections
Subject self-reporting of the number of days to develop an upper-respiratory infection
Time frame: 1 year
Upper Respiratory Infections
The total number of subjects to self-report an upper-respiratory infection
Time frame: 1 year
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)
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Time frame: baseline, 2 months
Change in 6-minute Walk Test
Distance a subject is able to walk over 6 minutes over a hard flat surface
Time frame: baseline, 2 months
Change in Grip Strength
Measured by a grip dynamometer as reported in units of pounds.
Time frame: baseline, 2 months
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)
Time frame: baseline, 2 months