Researchers are developing a new vaccine for hayfever which could be more effective, less invasive for patients and less expensive than vaccines already available to patients within the NHS.
Scientists at Imperial College London and King's College London have carried out a study which showed a significant reduction in skin sensitivity to grass pollen that was associated with an increase in 'blocking antibodies' in the bloodstream. The results are so encouraging that King's has today launched a clinical trial in collaboration with Guy's Hospital, working together as part of King's Health Partners. The trial is funded by the Medical Research Council and National Institute for Health Research via the Efficacy and Mechanism Evaluation programme, and will further investigate the vaccine as a potential new hayfever treatment.
The researchers say the approach defines a completely new concept in treating allergies and in the future could have an impact on treating other conditions such as asthma and food allergies.
Hayfever affects one in four people in the UK. An allergic reaction to grass pollen triggers a blocked or runny nose, sneezing, itchy eyes and in some cases asthma symptoms. For many individuals this can interfere with work or school performance, sleep and social activities. Tablets and sprays may temporarily relieve symptoms, but for severe cases one option is a vaccine to 'switch off' the allergy, called immunotherapy.
The vaccines currently used involve high doses of allergen given by injection underneath the skin (subcutaneously) or sometimes as a daily tablet or drops under the tongue. In most cases this involves large numbers of injections in an NHS allergy clinic or daily tablets/drops taken continuously, which can be inconvenient for patients and expensive for the NHS.
Published today in the Journal of Allergy and Clinical Immunology, this new study shows that a series of low dose allergen injections (less than a 1000th of the usual dose) into a higher layer of the skin (intradermally), rather than subcutaneously, led to a 90 per cent reduction in skin reactivity to grass pollen.
Researchers administered the vaccine intradermally to volunteer hayfever sufferers from Royal Brompton and Harefield NHS Foundation Trust. One group of subjects received six injections of grass pollen extract at two-week intervals over 10 weeks. The participants' allergic responses in the skin were then measured. The initial injection provoked an allergic reaction on the arm visible as a lump around 10 cm in diameter lasting 1-2 days. Over time a dramatic 90 per cent reduction was seen in the size of the lump suggesting that the allergic reaction was gradually being switched off with each injection. The size of the lump did not decrease in another group of subjects who received only two injections separated by 10 weeks.
During the study none of the participants reported unwanted side-effects and the injections did not trigger hayfever symptoms.
The researchers believe that the method of injecting the vaccine intradermally is a major factor in its success, as the skin is a highly active immunological area – more so than underneath the skin where allergy vaccines are traditionally administered.
Dr Stephen Till, Senior Lecturer at King's College London, said: 'The results of our study are hugely exciting. We now want to find out if this process can also switch off grass allergy in the nose and improve hayfever symptoms, so we are today launching the PollenLITE clinical trial to further test our new approach.'
Professor Stephen Durham, Head of Allergy and Clinical Immunology at Imperial College London, said: 'There is great interest in giving immunotherapy by novel alternative routes to improve uptake by the immune system. The results of this study provide an excellent foundation for going on to test the intradermal vaccine route in clinical trials.'
King's College London and Guy's and St Thomas' NHS Foundation Trust, as part of King's Health Partners Academic Health Sciences Centre, are today launching the PollenLITE trial to test this new vaccine. The trial is a collaboration with Imperial College London, which together with King's College London forms the basis of the MRC and Asthma UK Centre in Allergic Mechanisms of Asthma.
The PollenLITE team is looking for 90 hayfever sufferers to take part. Volunteers will receive either seven injections of small quantities of grass pollen into the dermis, or a placebo (dummy) injection in early 2013. In the summer of 2013 study participants will record their symptoms daily and scores will later be compared in the two groups. Small samples of skin and blood at the beginning and end of the study will be taken for experiments into how this new treatment works.
Dr Till at King's concluded: 'Hayfever is one of the most common diseases in the UK and can have a serious impact on people's everyday lives. PollenLITE is a major trial that has the potential to identify a new treatment that is more effective, convenient and cheaper for the NHS than the current alternative.
'Crucially, if this approach proves to be effective it would define a new scientific and clinical principle that could also be applied to other allergic diseases such as asthma and food allergies. This could be a pivotal study in immunological research.'
King's is now recruiting to the trial and people who experience summer hayfever (during the months of May, June and July), are welcome to apply.
Notes to editors:
For further information or a copy of the JACI paper please contact Emma Reynolds, PR Manager (Health) at King's College London, on 0207 848 4334 or email emma.reynolds@kcl.ac.uk
The trial is supported by the Clinical Trials Unit at King's College London and will take place at the Clinical Research Facility at Guy's Hospital. The facility is funded through the NIHR Biomedical Research Centre at King's and Guy's and St Thomas'.
The NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London focuses on 'translational research' across seven research themes and a number of cross-cutting disciplines, it aims to take advances in basic medical research out of the laboratory and into the clinical setting to benefit patients at the earliest opportunity. Access to the uniquely diverse patient population of London and the south east enables it to drive forward research into a wide range of diseases and medical conditions. www.guysandstthomasbrc.nihr.ac.uk
The study, published in JACI was carried out by researchers at the MRC and Asthma UK Centre for Asthma and Allergy at Imperial College London and King's College London.
PollenLITE = Pollen Low dose intradermal Therapy Evaluation
King's College London
King's College London is one of the top 30 universities in the world (2011/12 QS World University Rankings), and the fourth oldest in England. A research-led university based in the heart of London, King's has nearly 23,500 students (of whom more than 9,000 are graduate students) from nearly 140 countries, and some 6,000 employees. King's is in the second phase of a £1 billion redevelopment programme which is transforming its estate.
King's has an outstanding reputation for providing world-class teaching and cutting-edge research. In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in the top quartile of British universities; over half of our academic staff work in departments that are in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College is in the top seven UK universities for research earnings and has an overall annual income of nearly £450 million.
King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar. It is the largest centre for the education of healthcare professionals in Europe; no university has more Medical Research Council Centres.
King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.
NIHR EME
1. The Efficacy and Mechanism Evaluation programme supports later-phase "science-driven" clinical trials and evaluative studies, which seek to determine whether a health intervention (e.g. a drug, diagnostic technique or device) works and in some cases how or why it works.
2. The Efficacy and Mechanism Evaluation Programme (www.eme.ac.uk ) is funded by the MRC and NIHR, with contributions from the CSO in Scotland, NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. It is managed by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton.
3. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).
4. The Medical Research Council is dedicated to improving human health through excellent science. It invests on behalf of the UK taxpayer. Its work ranges from molecular level science to public health research, carried out in universities, hospitals and a network of its own units and institutes. The MRC liaises with the Health Departments, the National Health Service and industry to take account of the public's needs. The results have led to some of the most significant discoveries in medical science and benefited the health and wealth of millions of people in the UK and around the world. www.mrc.ac.uk
Journal
Journal of Allergy and Clinical Immunology