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Title: Four-Injection Vaccine May Provide Ragweed Allergy Symptom Relief: Presented at ACAAI

"Four-Injection Vaccine May Provide Ragweed Allergy Symptom Relief: Presented at ACAAI"

By Corinna S. Bowser, MD PHILADELPHIA, PA -- November 16, 2006 -- A vaccine approach to treating symptoms of ragweed allergy appears to be safe and effective, according to data presented here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). The short-course allergy vaccine under investigation (Pollinex Quattro) incorporates monophosphoryl lipid A (MPL) TLR4 agonist adjuvant. Results of a study presented here on November 13[^th show that treatment with this vaccine relieved symptoms and increased specific immunoglobulin (Ig) G with no important safety issues noted over the course of the study.

According to researcher Piyush Patel, MD, allergist in private practice, Mississauga, Ontario, Canada, the efficacy results appear to translate into improvements in quality of life for patients with ragweed allergy.

"There is also a large postmarketing study, from its use in Europe, that shows it is very well tolerated, with a low incidence of local and systemic reactions," Dr. Patel said in an oral abstract presentation.

The double-blind, placebo-controlled study included 177 ragweed-sensitive patients who underwent serial evaluations in an environmental exposure chamber that subjected them to controlled amounts of ragweed allergen.

To establish baseline symptom scores, patients underwent 3-hour ragweed exposures on 4 consecutive days. Vaccine was given in 4 weekly injections at doses ranging from 300-6000 SU in 87 patients, while 90 patients received placebo injections. Exposure chamber assessments were repeated 3 weeks after the last injection for 3 hours on 4 consecutive days.

Post-treatment reduction in total symptom score was -6.61 for treated patients and -4.47 for placebo (P = .007). In addition, increases in ragweed specific IgG level were significantly greater with the vaccine compared with placebo (3247.2 vs 36.6 ng/mL; P < .001).

Levels of IgE were not significantly different between the treatment and placebo groups.

Patient responses to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) specific to the environmental exposure chamber used in the study showed that the vaccine group had greater improvement in both global assessments and practical problems, Dr. Patel said.

Adverse events, which were mainly mild or moderate and related to injection site reactions, occurred in 153 patients. There were no severe adverse events.

Phase 2 studies of this vaccine have been completed, and it is expected that phase 3 studies in ragweed and grass allergy will begin shortly. Allergy Therapeutics, the company developing the vaccine and sponsored the study, has said it expects to launch the allergy vaccine in the United States in 2009.

[Presentation title: The Safety and Clinical Efficacy of Pollinex Quattro Ragweed Assessed in an Environmental Exposure Chamber. Abstract 22]

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