Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
- Registration Number
- NCT04176133
- Lead Sponsor
- Robert J. Pignolo
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entolimod 3 mcg Influenza vaccine Subjects will receive entolimod as a single dose administered intramuscularly (3mcg) Entolimod 1 mcg Influenza vaccine Subjects will receive entolimod as a single dose administered intramuscularly (1mcg) Placebo 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. Placebo Influenza vaccine 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. Entolimod 10 mcg Influenza vaccine Subjects will receive entolimod as a single dose administered intramuscularly (10mcg) Entolimod 10 mcg Entolimod Subjects will receive entolimod as a single dose administered intramuscularly (10mcg) Entolimod 3 mcg Entolimod Subjects will receive entolimod as a single dose administered intramuscularly (3mcg) Entolimod 1 mcg Entolimod Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)
- Primary Outcome Measures
Name Time Method Adverse Events 1 year 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
Change in Anti- A/H1N1 Antibody Titer Baseline, 1 month 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.
Change in Anti-B Antibody Titer Baseline, 1 month Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month..
Change in Anti-A/H3N2 Antibody Titer Baseline, 1 month 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.
- Secondary Outcome Measures
Name Time Method Time of Onset for Upper-respiratory Infections 1 year Subject self-reporting of the number of days to develop an upper-respiratory infection
Change in Grip Strength baseline, 2 months Measured by a grip dynamometer as reported in units of pounds.
Change in Body Mass Index (BMI) baseline, 2 months 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)
Upper Respiratory Infections 1 year The total number of subjects to self-report an upper-respiratory infection
Change in Frailty baseline, 2 months 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)
Change in 6-minute Walk Test baseline, 2 months Distance a subject is able to walk over 6 minutes over a hard flat surface
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States