Phase II, Influenza A, study examining PrEP-001 in healthy subjects
Research type
Research Study
Full title
A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged with Influenza A/Perth/16/2009(H3N2) Virus.
IRAS ID
185944
Contact name
Samuel Israel
Contact email
Sponsor organisation
hVIVO Services Limited
Eudract number
2015-002895-26
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a Phase 2 study, to look at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
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.
There will be 2 study groups:
Cohort A: (Sentinel): to determine the Challenge Virus infection rate after inoculation with 100 µL Influenza Virus on Day 0. There will be 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.
Cohort B: to examine the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). 44 subjects (possible increase to 58, if deemed necessary) will attend on Day -4/-3, dosed with PrEP-001 or Placebo on Day -2 AND Day-1and then challenged with virus (volume confirmed from Cohort A) on Day 0.Up to 14 subjects will be kept as reserve subjects.
Volunteers will remain in the quarantine unit for 8 days after inoculation but should medical monitoring warrant an additional night or 2 stay then they may be asked to stay longer.
During the day 28 (+/- 5) end of study visit, 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 - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0275
Date of REC Opinion
27 Aug 2015
REC opinion
Favourable Opinion