RSV Study in Adults 60 to 75 Years of Age
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|ClinicalTrials.gov Identifier: NCT03919591|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|RSV Infection||Other: Challenge virus RSV-A Memphis 37b||Not Applicable|
RSV is a common virus that affects all human age groups. Typical RSV illness is identified by symptoms such as runny nose, stuffy nose, sneezing, sore throat, earache, malaise or tiredness, cough, shortness of breath, headache, muscle ache, joint ache or stiffness, chilliness and feverishness. RSV spreads easily from person to person through the eyes, nose or mouth when droplets containing the virus, such as those from coughing or sneezing, are inhaled or passed to others. Adults with risk factors, like another illness or disease, may experience an RSV illness that is more severe or lasts longer. RSV may also start a worsening of health in frail adults, people with weak immune systems, and those with chronic cardio-pulmonary disease.
No treatment or vaccine to treat or prevent RSV disease is available in the UK. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults as well as other high-risk adult and paediatric populations. The use of RSV human viral challenge model provides an important tool to evaluate the effectiveness of new RSV vaccines. Specifically, a RSV human viral challenge in 60 to 75-year-old individuals would enable measuring the effectiveness of RSV vaccines in a population that is thought to be less responsive to vaccines than the 18-45-year-old population.
The purpose of this study is to infect up to 50 healthy subjects aged 60 to 75 years old with RSV in a controlled quarantine environment to confirm how safe and well tolerated the use of an experimental RSV virus infection is in a population that has not previously received the virus. Additionally, the investigators will also look at various components of the subjects' 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.
The study will consist of 3 phases: 1) Screening, 2) Quarantine and 3) Follow-up.
The enrolment of the subjects will be staggered with safety data reviews performed between groups. Each volunteer will be in the study for approximately 3 months from screening to their last scheduled clinic visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Each subject will receive one titre of the Challenge Virus intranasally.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Actual Study Start Date :||March 12, 2019|
|Estimated Primary Completion Date :||June 21, 2019|
|Estimated Study Completion Date :||June 21, 2019|
Open Label Pilot
Open Label Pilot Study. All subjects will receive the viral challenge inoculum.
Other: Challenge virus RSV-A Memphis 37b
Each subject will receive one titre of virus, which will be up to approximately 4 log10 PFU.
- Number of routine clinical assessment abnormalities reported as adverse events. [ Time Frame: Safety data collected throughout the study (estimated 4 month). ]
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).
- Number of safety laboratory assessment abnormalities reported as adverse events. [ Time Frame: Safety data collected throughout the study (estimated 4 month). ]
- 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.
- Number of subjects with study related Adverse Events (AEs) [ Time Frame: Safety data collected throughout the study (estimated 4 month). ]
- use of concomitant medications
- frequency and severity of AEs.
- Viral loads/shedding measurement following inoculation with RSV [ Time Frame: Virology and clinical data collected throughout the study (estimated 4 month). ]The AUC of RSV-A Memphis 37b viral load measured in nasopharyngeal swabs by qPCR (log10 copies/mL units) and by cell base infectivity assay (log10 copies/mL units).
- Duration of viral shedding. [ Time Frame: Virology and clinical data collected throughout the study (estimated 4 month) ]The time (in hours) from first detectable viral shedding to first undetectable viral shedding.
- Measurement of the total mucus weight produced. [ Time Frame: Virology and clinical data collected throughout the study (estimated 4 month). ]Total weight of nasal discharge (grams).
- Measurement of symptoms severity by self reported symptoms diary cards. [ Time Frame: Symptom Diary Cards data is collected throughout the quarantine period (estimated 15 days) ]Symptoms are recorded on a grading scale of 0 to 3.
- Measurement of the peak tympanic temperature. [ Time Frame: Temperature data is collected from day 0 to day 12. ]Time of the highest recorded tympanic temperature.
- Number and percentage of subjects with confirmed RSV infection. [ Time Frame: Virology data collected throughout the study (estimated 4 month) ]Confirmed infection is measured by the presence of viral shedding in nasopharyngeal swabs.
- Number and percentage of subjects with Upper and Lower Respiratory Tract Infection (URTI and LRTI) [ Time Frame: Clinical data collected throughout the study (estimated 4 month) ]URTI and LRTI are evaluated from Symptom Diary Cards and Physical Examination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919591
|Contact: Andrew Catchpole, PhDemail@example.com|
|Contact: Kingsley Ezefirstname.lastname@example.org|
|hVIVO Services Limited||Recruiting|
|London, United Kingdom, E1 2AX|
|Contact: Mariya Kalinova, MD, MBBS +442077561300 email@example.com|