2. Can I be involved in the Vaccine trial? And when is the Vaccine likely to be available?

April 3, 2014 0

GMP manufacture of the first component of the vaccine has been successfully completed by the Jenner Institute, Oxford, with over 300 vials of vaccine produced. GMP manufacture of the second component of the Vaccine is ongoing. Phase I trials in healthy human volunteers are expected to begin in Dec 2016. These will be followed by a Phase II trial, anticipated to begin in the third quarter of 2017. The Phase II trial will be a single-centre trial based at St. Thomas’s Hospital, London, UK in 20 adults with Crohn’s Disease and will last 1 year. The estimated timeline of the Vaccine manufacture and trials is shown in the Gantt Chart below. The patients recruited to this trial will need to meet strict entry criteria; there are stringent regulations which we have to obey and the trial will be governed by the close scrutiny of the regulators. Regrettably we cannot invite people to take part in the trial at this time. However, the results of the trial will be analysed in real time as it proceeds. As soon as there is evidence of safety and efficacy, we can apply for use of the vaccine on compassionate grounds; this will enable people who wish to have the vaccine but are unable to be part of the trial to access it on a named-patient basis outside of the trial. Indeed, under the newly proposed ‘Early Access to Medicines’ scheme in the UK, severely ill patients who have failed existing treatments may be granted access to new medicines that are proven to be safe, even before efficacy has been fully established. This means that the earliest the vaccine could be made available to patients on a named-patient basis would be late 2017. In addition, following the demonstration of safety and efficacy, it is anticipated that the Vaccine technology would be licenced to a pharmaceutical company to make it available to all who need it through health services worldwide -as part of this, larger Phase 3 trials inviting wider participation would be expected. The manufacture and trial of the Vaccine is being funded through investment in the company HAV Vaccines Ltd (HVL) -completion of the trial according to this timescale is dependent on HVL to secure the remainder of the funding required.