[COMMUNICATED*] This is a randomized, double-blinded, placebo controlled study investigating a form of subcutaneous injections (needle injections given just under the skin), which has been developed by the study sponsor, Allergy Therapeutics (UK) Ltd., for the treatment of grass pollen allergy.  The product has been available in Europe for the past 15 years and the present studies are being done under the FDA to obtain permission for their use in the US.

The course of treatment injections is designed to provide specific immunity to (protection against) grass pollen allergy for the long term relief of symptoms like runny, stuffy nose, sneezing, and itchy, watery eyes when exposed to grass pollens.  The  participation in this clinical study is entirely voluntary. One can only take part in this study after you have given your written consent.

Volunteers will be compensated up to $6,100 for completing the study in its entirety.  In total there are 16 clinic visits + 4 telephone calls. Involves a skin test to prove that the patient has grass pollen allergy and if that is positive then a blood test to reaffirm the skin test. If the blood test is positive then the patient is exposed to pollen in a chamber to measure their clinical severity. If positive, then they are randomized to either placebo or a treatment regimen that includes 6 allergy injections over 8 weeks.  6-8 weeks later they are exposed to pollen again to see the effect of the treatment.

The study is looking for males and females ages 18-50 who have had troublesome, to very troublesome, allergy symptoms despite the use of anti-allergy medications for the past 2 years or longer. 

TOTAL $6100 for 16 visits. Transportation is also reimbursed. 

The study sites include Wall Township – call office (732) 449-0914 (intersection of Routes 35 and 195) @ 20 minutes from Lakewood and in Springfield, New Jersey (Call 973-912-9817).

For more detailed information about the study check www.NJpollen.com

About Seasonal Allergic Rhino-conjunctivitis

Seasonal allergic rhino-conjunctivitis is commonly referred to as hay fever when it is caused by pollen. It is a widespread disease that usually occurs during the pollen season. It is characterized by sneezing, rhinorrhea, nasal congestion and pruritus of the nose, eyes or throat. It is a type I hypersensitivity response in which the allergen binds to immunoglobulin E on the surface of mast cells. This response leads to the release of histamine, prostaglandins and leukotrienes, which cause the common hay fever symptoms of inflammation, itching and redness.

About Allergen Specific Immunotherapy

Allergy immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It is essentially a reinforcement of the body’s own defence mechanisms and is similar to preventative vaccination against infectious disease; an area of medicine that has reached spectacular success. In allergy vaccination, the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response. Allergy vaccination attacks the underlying cause of the problem and usually provides a patient with long lasting benefit. The World Health Organization recognizes allergy vaccination as the only treatment to target the immunological cause of allergy with the ability to modify disease progression, decreasing symptoms in the short term and offering long term anti-inflammatory benefits which prevent the development of persistent disease. Allergy vaccination, therefore, has the potential of offering patients a cure for their disease.

About the Grass Pollen “Allergy Shot”

The investigational product is designed for use in the USA based upon the Pollinex Quattro product distributed in the EU. It offers short-course therapy (4-6 injections) providing same-season relief in as little as three to five weeks after treatment. As it is currently available in Europe, the evidence of the safety and efficacy of the grass pollen vaccine has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data with more than 4 million doses.

Natural allergens are chemically modified to remove allergenicity (allergoids) that improves safety and allows for delivery of higher doses. Allergoids are combined with the depot adjuvant technology to provide prolonged desensitization and further improved tolerability. Finally, the immune response is specifically enhanced with an agent that has been extensively tested in Pollinex Quattro and other late stage and USA registered vaccines including GlaxoSmithKline’s Fendrix® and Cervarix®.

Leonard Bielory, M.D., one of New Jersey and New York’s  “Top Physicians” for the past 25 years and is Professor of Medicine, board certified specialist in allergy and immunology who is associated with the Rutgers University Environmental and Occupational Health Institute and the School of Environmental and Biological Sciences and on faculty at the Robert Wood Johnson University Hospital in New Brunswick, New Jersey.

Dr. Bielory is principal investigator on a long-term U.S. Environmental Protection Agency grant to study the potential impact of such changes on human population and what to expect over the course of the next 50 years. Preliminary reports, suggest that allergies will likely become an increasing problem that “ will not only affect our children, but our grandchildren” — for the next two to three generations.

In addition, Dr. Bielory has been leading multiple clinical studies on asthma, ocular allergy, nasal and sinus allergic disorders and is the oldest pollen counting station in New Jersey. (http://www.njpollen.com/)

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