Placebo-controlled study of oral VX-787 against influenza
Research type
Research Study
Full title
A Phase 2a, Randomized, Double Blind, Placebo Controlled Study to Investigate the Effects of VX-787 Administered to Adult Volunteers Experimentally Inoculated with Live Influenza Virus
IRAS ID
98127
Contact name
Anthony Gilbert
Contact email
Sponsor organisation
Vertex Pharmaceuticals (Europe) Ltd
Eudract number
2011-005929-49
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
A randomised, double-blind, placebo controlled study assessing the effects of the study drug, VX-787, on healthy adult volunteers exposed to Influenza during an 11-12 day quarantine period.
Volunteers will be screened to identify approximately 140 volunteers who will be dosed with flu virus strain, influenza A/Wisconsin/76/2005 (H3N2), and monitored by medical staff during the quarantine phase of the study.
If volunteers have not undergone antibody blood testing at Retroscreen within approximately 5 months prior to study virus exposure, they will be tested for the presence of antibodies to the Influenza virus. Volunteers who have low levels of antibodies to Influenza will attend a study specific screening visit.
On day -2, volunteers will attend the quarantine unit. Volunteers will be tested for the presence of different viruses; volunteers confirmed as being positive will be excluded from the study. Volunteers will be excluded if they have a fever or 'cold or flu-like' symptoms between arrival at the quarantine unit and the day of study virus administration. The study physician will provide a referral for medical care if necessary. Eligible volunteers will be randomised to receive study drug (VX-787) or placebo. This will occur 3 days after entering the quarantine unit on study day 1.
Volunteers will receive the study virus 2 days after entering the quarantine unit on study day 0. They will remain in quarantine unit for another 8 days (or 9 days or longer if required by the study physician). It is rare for a volunteer to stay longer than this.
Following discharge from the quarantine, volunteers will attend a follow up visit, approximately 28 days after exposure to the study flu virus. Further follow up visits will be scheduled if necessary by the study physician.
REC name
London - City & East Research Ethics Committee
REC reference
12/LO/0102
Date of REC Opinion
7 Mar 2012
REC opinion
Favourable Opinion