Influenza Vaccine Trial 'FLU 003'
VOLUNTEER INFORMATION SHEET
From: Prof. Adrian Hill, Chief Investigator, Flu Vaccine Trials Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital, Headington, Oxford OX3 7LJ
Tel: 01865 857401 (co-ordinator) email: vaccinetrials@well.ox.ac.uk
A phase I study to determine the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 and seasonal influenza vaccine (FLU003)
(OxREC A number_11/SC/0299_)
We would like to invite you to take part in a research study. Before making a decision you need to understand why the research is being done and what it would involve. Please take time to read the following information carefully. Talk to others about the study if you wish. Ask us if there is anything that is not clear or if you would like more information.
If you are interested in taking part in the study and would like more information please fill in the Registration form below and a member of the study team will contact you.
What is the purpose of this study?
The purpose of this study is to test the combination of the current seasonal flu vaccine together with a new vaccine against flu in adults aged over 50.
Existing flu vaccines contain proteins from the flu virus. The vaccination helps protect you from flu by stimulating your immune system to produce antibodies against these proteins. Currently flu vaccines use proteins from the outside of the flu virus. A problem with this approach is the flu virus changes its surface proteins every year meaning a new vaccine has to be made and used every year.
We have been developing a new type of flu vaccine called MVA-NP+M1. MVA stands for Modified Vaccinia virus Ankara. It is a weakened form of the smallpox vaccine (Vaccinia). This virus has been used in a similar way in many other vaccine programmes and has an excellent safety record. NP and M1 are two proteins from flu (nucleoprotein and matrix protein 1). This new vaccine uses the internal proteins of the flu virus instead of the outer proteins. These inner proteins remain virtually unchanged year on year, which means our vaccine won’t have to keep changing.
We have tested this new vaccine in 43 volunteers under the age of 50 and 23 volunteers aged over 50 (i.e 66 volunteers in total). The information from these volunteers has allowed us to choose a dose of the vaccine that balances the side effects with the size of the immune response.
Some of our previous volunteers have received both the normal flu vaccine and our experimental flu vaccine in the same flu season. However we have not given the two vaccines together at the same time before.
In this study the two vaccines will be given with separate injections, one after the other, into the thigh. We are not giving our vaccines into the arm as the muscle will be too small to accommodate two vaccines. We are not allowed to mix the vaccines and give them together with a single injection.
The aim of this study is therefore to try and prove whether the combination of the two vaccines does stimulate a strong immune response or not. We will also look carefully at the safety profile when the two vaccines are given together.
Can I take part?
To take part you need to be aged over 50 and not have any major health problems. You should not be participating in any other research studies at the same time and if you have received any experimental vaccines in the past you will need to discuss this with a member of the research team. Mild health conditions would not automatically exclude you from participating. Pre-menopausal women would need to use contraception, because you must not take part if you are pregnant or wish to become pregnant. If you want to take part you will need to comply with all of the study requirements and be able to attend all of the follow up visits.
Participation is entirely voluntary and you are free to withdraw at any time, for any reason.
