Characterise a new preparation of Respiratory Syncytial Virus stock
Research type
Research Study
Full title
An Exploratory, Open-label Study to Characterise a New Preparation of Respiratory Syncytial Virus (RSV) Challenge Virus Stock
IRAS ID
263896
Contact name
Gini Brickwell
Contact email
Sponsor organisation
hVIVO Services Limited
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
In this study, up to 24 subjects will be inoculated for each preparation of challenge virus, with a total study sample size of up to 72 subjects
The study consists of three parts:
1) Screening: Volunteers with low resistance (serosuitability) to the RSV challenge virus will be invited to attend a screening visit within 90 days prior to entry to quarantine. Assessments previously conducted under hVIVO’s generic screening process may be used for this study to determine eligibility. In this case, participants will not be required to attend a study specific screening visit and their eligibility will be assessed using results from previous screening assessments. Study-specific consent may occur on the day of quarantine admission.2) Quarantine phase: Two or one day prior to the day of inoculation with RSV challenge virus, volunteers will be admitted to quarantine where their eligibility will be reassessed. If volunteers remain eligible they will receive the challenge virus on Day 0. Volunteers will be discharged from the quarantine unit on Day 12, or later, based on their clinical condition and the Principal Investigators assessment. Volunteers will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine.
3) Follow-up: Volunteers will attend a follow-up visit, 28 (±3) after the day they receive the virus. Their symptoms will be reassessed and a complete safety examination performed.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0655
Date of REC Opinion
31 May 2019
REC opinion
Further Information Favourable Opinion