Exploratory RSV Pilot Study in Adults 60 to 75 Years of Age
Research type
Research Study
Full 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.
IRAS ID
257523
Contact name
Mariya Kalinova
Contact email
Sponsor organisation
hVIVO Services Limited (hVIVO)
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 8 months, 14 days
Research summary
In this study, up to 50 subjects aged 60 to 75 years old will be inoculated with the Respiratory Syncytial Virus (RSV) in a controlled quarantine environment.
The study will consist of:
1) Screening: Subjects will attend a screening visit between Day -56 to Day -3 prior to inoculation. Assessments previously conducted under hVIVO’s generic screening process may be used for this study to determine eligibility.
2) Quarantine: Eligible subjects will be invited to quarantine on Day -2 or -1 and if they remain eligible they will be inoculated on Day 0. Subjects will be discharged on Day12, or later, based on their clinical condition. Subjects will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine.
3)Follow-up: Subjects receive Follow up phone calls starting from day 15 and occurring every 3 days (± 1 day) up to and including day 27. Subjects will attend a follow-up visit on Day 28 (±3) after the day they receive the virus.
Each volunteer will be in the study for approximately 3 months from screening to their last scheduled clinic visit.
The enrolment of the subjects will be staggered in small quarantine groups starting with a group of up to 4 subjects aged 60-69 years old. Following a first review of the safety data, additional subjects in this age group will take part until 12 have completed the quarantine phase. Once 12 subjects have taken part, a second safety review will be performed before another 12 subjects between the ages of 60 and 75 years can take part. After 24 subjects have completed the study, an interim analysis will be performed and a decision will then be made as to whether to close the study or continue recruiting up to 50 subjects.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0398
Date of REC Opinion
31 Jan 2019
REC opinion
Further Information Favourable Opinion