Phase II HRV16 study examining PrEP-001 in asthmatics
Research type
Research Study
Full title
A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged with Human Rhinovirus (HRV-16 [hVIVO])
IRAS ID
188271
Contact name
Cyrus Ghobadi
Contact email
Sponsor organisation
hVIVO Services Limited
Eudract number
2015-004042-26
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a Phase 2 study, to examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatics who have been infected with the Human Rhinovirus (HRV16) after receiving two doses of the study drug/placebo.
The study consists of 3 parts: Screening, Quarantine Phase and Follow Up.
Screening will take place up to 90 days before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.The Quarantine (Challenge) Phase is where volunteers who fulfil eligibility criteria will be admitted to the purpose built quarantine facility in London to be given the study drug or placebo and challenged with the virus.
A total of 40 eligible volunteers will be invited to test and record their Peak Expiratory Flow (PEF), medications and any adverse events in diary cards from Day -14 to Day -5. They will then attend Quarantine on Day -4/-3, receive the study drug/placebo intra nasally on Day -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study drug/placebo will be 1:1.
Volunteers will remain in the quarantine unit for 8 days after inoculation but should medical monitoring warrant an additional night or longer then they may be asked to stay longer.PEF self-testing will continue from Day 9 to Day 28. Volunteers will return to the unit for two follow up visits; Day 20 (±3 days) and Day 28 (±5 days) during which each volunteer will be seen and assessed by a study physician for well-being, on-going symptoms and adverse events.
The total duration of the clinical phase of the study, from the start of volunteer screening to the last subject’s last scheduled visit (LSLV) is expected to be approximately 12 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0358
Date of REC Opinion
17 Nov 2015
REC opinion
Further Information Favourable Opinion