Purpose of this research study
The investigational medication being tested in this study is GrassMATAMPL in the form of subcutaneous injections (needle injections given just under the skin), which has been developed by the study sponsor. The course of 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. There is increasing evidence that the effectiveness of allergy immunotherapies is correlated to the cumulative dose (total combined dose of treatments) of allergen administered. Higher cumulative doses of allergen increase the efficacy of the product.
This study utilizes Inflamax Research's mobile Environmental Exposure Chamber, referred to as mEECTM, to bring on allergy symptoms in a controlled manner. You are required to attend two, four day sessions, at either the Cincinnati, Ohio, or Neptune, New Jersey EEC. At the EEC you will answer questions about your allergy symptoms inside the EEC. Each EEC session will last for 3 hours, and the total time at the site will be approximately 4.5hrs per day.
If you are deemed eligible to continue in the study after the first 4 EEC visits, you will return to your local study clinic for 6 study treatment visits approximately one week apart. After the study treatment visits you will return to the same EEC location for the second set of EEC sessions; 4 days, approximately 4.5hrs per day. Finally, you will return to your local study clinic for one follow-up visit. After this follow-up visit, 3 scheduled telephone interviews will be conducted at 3,6, and 12 months after your last study treatment day.
Allergic subjects sit in an environment room and are exposed to a controlled level of airborne allergen. Volunteers exposed to allergen in this environment develop allergic symptoms in a known, predictable manner. The volunteers are asked to record instantaneous symptoms on a diary card. The resulting data are superior compared to traditional methods of evaluating anti-allergic therapies in development.
The investigational medication being tested in this study is GrassMATAMPL in the form of subcutaneous injections (needle injections given just under the skin), which has been developed by the study sponsor, Allergy Therapeutics (UK)Ltd. The course of 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 substance injected consists of grass pollen extracts, which has been modified by a chemical called glutaraldehyde to reduce its allergic potential which can cause local and whole body reactions. These extracts are adsorbed onto substance called tyrosine which is a natural component of the body but when given with the pollen extract helps to release it slowly from the injection site. This is the basis of the name, Modified Allergen Tyrosine Adsorbate shortened to MATA. In addition a substance called Monophosphoryl lipid A (MPL®) has been added to enhance the protective immunostimulating properties of the product. Both tyrosine adsorption and the addition of MPL® is expected to produce greater efficacy while at the same time reducing incidence and the severity of the side effects seen in the older unmodified products. GrassMATAMPL products have been available to patients in some European countries since 1999.
Please ask yourself the following questions to determine if you may be eligible to come for a screening visit. Please note, the following questions are not meant to be an extensive list of study criteria, only an indication of if you may be a suitable candidate for this study. A full telephone pre-screening can be done if you call us at the number at the top of the page.
Total value for participation $6100
If you answered YES to the above questions, you should call us at 973-912-9817, or register online using the form below. One of our volunteer recruitment staff will contact you and provide more details, and perform a thorough pre-screening questionnaire to determine your eligibility.