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| |  Experimental Vaccine Builds Up Immune Response to Ragweed Allergies: Presented at ACAAI By Carole Bullock DALLAS, TX -- November 14, 2007 -- A new vaccine against ragweed pollen raised immune responses in a dose-dependent fashion, researchers reported here at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI). The vaccine was safe, tolerable, and increased ragweed-specific immunoglobulin G (IgG), reported William Howland, MD, Allergist, Austin, Texas, United States in a presentation on November 12. The multicentre, double-blind, dose-dependent, phase 2b study enrolled 68 subjects (n = 20 in each active group, n = 8 in the placebo group), who received 3 doses of Pollinex Quattro Ragweed (PQR), a new vaccine comprised of tyrosine-adsorbed ragweed pollen allergoids with the immunologic adjuvant monophosphoryl lipid. Three doses: low (300/300/300/300 standardized units [SU]), intermediate (300/700/700/2,000 SU), or therapeutic (300/700/2,000/6,000 SU) were delivered in 4 0.5 mL subcutaneous injections every 7 days. The placebo group followed the same protocol. Blood samples for immunologic testing were taken at screening (baseline), prior to each study drug administration and post treatment (14 days after the last injection). Serum concentrations of ragweed-specific IgG, IgG1, IgG4, and IgE were determined and safety was assessed as a secondary objective. The vaccine effectively increased ragweed-specific IgG, IgG1, and IgG4 levels in a dose-dependent manner. Small non-dose-dependent increases in IgE levels for all doses were observed compared with placebo. PQR was well tolerated. Most adverse events were mild or moderate in intensity with the most common report being of injection-site reactions. Two subjects withdrew because of an AE: one in each of the therapeutic-and intermediate-dose groups. "The study was designed to look at immunological parameters, so we can't make conclusions about the clinical effects. However, the improvement in the IgE indicated that this may be tied to improved symptoms," said Dr. Howland. Allergy Therapeutics funded the study.
[Presentation title: Immunologic Effect and Safety of Ultra-Short Course Subcutaneous Immunotherapy (MUscit) With Pollinex Quattro Ragweed. Abstract 40]
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