RSV Study in Adults 60 to 75 Years of Age

NCT03919591 | Completed DMC

• 1 other identifier: RVL-OCS-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RSV Infection

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (7)

• 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.

Study Arms (1)

Open Label Pilot

OTHER

Open Label Pilot Study. All subjects will receive the viral challenge inoculum.

Other: Challenge virus RSV-A Memphis 37b

Interventions

Challenge virus RSV-A Memphis 37b OTHER

Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.

Open Label Pilot

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects aged 60 to 75 years
• Able to give informed consent
• A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 33 kg/m2.
• In good health with no history of major medical conditions, or clinically significant test abnormalities that will interfere with subject safety as determined by the Investigator at screening evaluation
• Documented medical history either prior to entering the study and/or following medical history review by the Investigator at screening.
• Serum IgA result within normal range at screening.
• Subjects meeting the contraception criteria of the study.

You may not qualify if:

• Subjects who have smoked ≥ 10 pack years (or 20 cigarettes a day for 10 years). Of those subjects that have smoked less than 10 pack years at any time, a subject will be excluded, if in the last year, he/she has smoked any number of cigarettes in the last month and/or they have used tobacco in any form or other nicotine-containing products in any form.
• Subjects who smoked in the last month prior to the study
• Females who are breastfeeding, have been pregnant within 6 months prior to the study, or have a positive pregnancy test.
• History of clinically significant or major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations.
• A forced expiratory volume in 1 second (FEV1) \< 80% predicted.
• Twelve-lead ECG recording with clinically relevant abnormalities.
• Positive HIV, Hep A, B or C test.
• Confirmed positive test for drugs of abuse.
• Presence of fever prior to the challenge.
• Evidence of vaccinations within the 4 weeks prior to the planned date of enrolment, or intention to receive any vaccination before the last scheduled visit of the study.
• Those employed or immediate relatives of those employed at hVIVO.
• Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to the planned date of enrolment.
• Receipt of systemic glucocorticoids or systemic antiviral drugs within 6 months prior to the planned date of enrolment.
• History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to enrolment.
• Any clinically significant history of large nosebleeds.

Sponsors & Collaborators

• Hvivo: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

hVIVO Services Limited

London, E1 2AX, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will receive one titre of the Challenge Virus intranasally.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 18, 2019
• Study Start: March 12, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)