You are invited to take part in a study to investigate a new vaccine for Shigella. The study is being run by the Oxford Vaccine Group which is part of the University of Oxford.
If you are 18 to 55 years old and in good health, then you may be eligible to take part. We will provide reimbursement up to a maximum of £530 for your time, inconvenience and travel. The total study participation time is 6 months from the vaccination.
Background
Shigella is a group of bacteria which are well known to cause food poisoning throughout the world. In certain circumstances they can cause severe bloody diarrhoea (dysentery), known as shigellosis, and less often Shigella can spread beyond the gut leading to blood poisoning, and in some cases sepsis and death. This is of particular concern in individuals with a weaker immune system. Shigella bacteria are transmitted through contaminated food or water supplies or from person to person through direct contact via unclean hands or surfaces. Shigella bacteria cause around 200,000 deaths per year, with 60,000 of these in children under 5 years old and are a particular problem in southern Africa and Asia.
Study Goals
In this study we are investigating a new vaccine against Shigella called the Shigella4V vaccine. The vaccine has previously been used in a study in adults and children in Kenya, and a very similar vaccine (called Flexyn2a) has also be studied in clinical trials in adults and children. The vaccine does not contain live bacteria and will not infect you with the illness.
We are aiming to confirm the safety and investigate the development of immunity following vaccination.
Study Details
If eligible and if you do decide to take part, you will be enrolled into 1 of 2 groups to receive 1 vaccination of either a half dose or a full dose of the Shigella4V vaccine. After receiving the vaccine, you would be required to complete an electronic diary for the next seven days. You would also be required to provide blood samples before the vaccination and at three subsequent follow-up visits.
The Oxford Vaccine Group, University of Oxford, is based at the Churchill Hospital, where all study visits/appointments will take place.
If you would like to find out more, please read the Participant Information Sheet PIS
In addition, if you would like any further information regarding the study please contact us on:
Email: info@ovg.ox.ac.uk Tel: 01865 611400
If you are interested in joining the study please visit Online questionnaire where you can access the online screening questions and register your interest.