Characterise a New Preparation of RSV Challenge 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
250187
Contact name
Mariya Kalinova
Contact email
Sponsor organisation
hVIVO Services Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
In this study, up to 24 healthy subjects aged between 18 to 55 years of age, will be infected with the new preparation of RSV-A Memphis 37b challenge virus from previous stock. \n\nThe study consists of three parts:\n1) 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.\n\n2) 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.\n\n3) 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. Volunteers whose samples may be suitable for further testing, may be invited to attend an optional second follow-up visit at 6 months (± 2 weeks).
REC name
Wales REC 5
REC reference
18/WA/0244
Date of REC Opinion
23 Jul 2018
REC opinion
Favourable Opinion