NCT03919591|CompletedDMC
RSV Study in Adults 60 to 75 Years of Age
An Exploratory Pilot Study to Evaluate the Clinical Safety and Virologic Profile of an Experimental RSV Infection in Adults 60 to 75 Years of Age
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An Exploratory Pilot Study to Evaluate the Clinical Safety and Virologic Profile of an Experimental RSV Infection in Adults 60 to 75 Years of Age
Sponsor study identifier
interventional
24
1 country
1
Study Start
March 12, 2019
Actual (reported)Primary Completion
July 11, 2019
Actual (reported)Study Completion
July 11, 2019
Actual (reported)The purpose of this study is to infect healthy volunteers aged 60-75 years old with Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an experimental RSV virus is in a population that has not previously received the virus. Additionally, this study will also look at various components of the volunteers' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 11, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2019
Actual (reported)April 1, 2019
Actual (reported)April 18, 2019
Actual (reported)July 11, 2019
Actual (reported)July 11, 2019
Actual (reported)Number of routine clinical assessment abnormalities reported as adverse events.
Multiple safety clinical parameters will be used for safety evaluation: * Vital signs parameters (systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (breaths per minute), heart rate (beats per minute) and SpO2 (%) * Tympanic temperature (deg C) * Spirometry parameters (FEV1(absolute), FEV1(% predicted), Forced vital capacity (FVC) (absolute), FVC (% predicted), FEV1/FVC ratio (absolute), FEV1/FVC ratio (% predicted) * ECG parameters (Heart Rate (beats/min), PR interval (msec), QRS duration (msec), QT interval (msec), QTc interval (msec), QTcB interval (msec), QTcF interval (msec) and RR interval (msec)) * Physical examination (complete examination and directed examination assessments).
Safety data collected throughout the study (estimated 4 month).
Number of safety laboratory assessment abnormalities reported as adverse events.
* Haematology: platelet count, WBC count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocyte count, reticulocyte count \[ each reported in 10\^9/L\]; RBC count (10\^12/L), haemoglobin (g/L), haematocrit (%), MCV (fL), MCH (PG), MCHC (g/L), Haemoglobin A1c * Biochemistry: sodium, potassium, glucose, chloride, bicarbonate, calcium, inorganic phosphate, urea, total cholesterol \[each reported in mmol/L\]; uric acid, creatinine, total bilirubin, indirect bilirubin, direct bilirubin \[each reported in umol/L\]; serum albumin (g/L), total protein (g/L), blood urea nitrogen (mg/dL), CRP (mg/L), GGT (IU/L), ALP (IU/L), ALT (IU/L), LDH (IU/L), AST (IU/L), urea (mmol/L), total cholesterol (mmol/L), Estimated Glomerular Filtration Rate. * Coagulation: PT (secs), APTT (secs) * Cardiac Enzymes: creatine kinase (IU/L), troponin T (ng/L) * Urinalysis: colour, specific gravity, appearance, pH, blood, glucose, leukocytes, ketones, nitrite, protein, urobilinogen, bilirubin.
Safety data collected throughout the study (estimated 4 month).
Number of subjects with study related Adverse Events (AEs)
* use of concomitant medications * frequency and severity of AEs.
Safety data collected throughout the study (estimated 4 month).
Viral loads/shedding measurement following inoculation with RSV
Virology and clinical data collected throughout the study (estimated 4 month).
Duration of viral shedding.
Virology and clinical data collected throughout the study (estimated 4 month)
Measurement of the total mucus weight produced.
Virology and clinical data collected throughout the study (estimated 4 month).
Measurement of symptoms severity by self reported symptoms diary cards.
Symptom Diary Cards data is collected throughout the quarantine period (estimated 15 days)
Measurement of the peak tympanic temperature.
Temperature data is collected from day 0 to day 12.
Open Label Pilot Study. All subjects will receive the viral challenge inoculum.
Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
hVIVO Services Limited
London, E1 2AX, United Kingdom
24 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2019
First Posted
April 18, 2019
Study Start
March 12, 2019
Actual (reported)RESCEU: Defining the Burden of RSV Disease
Contact the study team to confirm eligibility.
Primary Completion
July 11, 2019
Actual (reported)Study Completion
July 11, 2019
Actual (reported)Last Updated
October 14, 2019
Record last verified: 2019-10
Anonymised data might be shared with hVIVO's research partners
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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