Safety, tolerability, and impact on allergic inflammation of autologous <it>E.coli </it>autovaccine in the treatment of house dust mite asthma - a prospective open clinical trial

• Main Authors: Schulze Johannes, Schubert Ralf, Weigand Bianca, Rose Markus A, Zielen Stefan
• Format: Article
• Language: English
• Published: BMC 2011-06-01
• Series: BMC Complementary and Alternative Medicine
• Subjects: autovaccine; safety; tolerability; house dust mite allergy; asthma
• Online Access: http://www.biomedcentral.com/1472-6882/11/45

<p>Abstract</p> <p>Background</p> <p>Asthma is increasing worldwide and results from a complex immunological interaction between genetic susceptibility and environmental factors. Autovaccination with <it>E. coli </it>induces a strong TH-1 immune response, thus offering an option for the treatment of allergic diseases.</p> <p>Methods</p> <p>Prospective open trial on safety, tolerability, and impact on allergic inflammation of an autologous <it>E.coli </it>autovaccine in intermittent or mild persistent house dust mite asthma. Determination of exhaled nitric monoxide (eNO) before and after bronchial mite challenge initially and after nine months of autovaccination.</p> <p>Results</p> <p>In nine subjects and a total of 306 injections, we observed 101 episodes of local erythema (33.3%; median of maximal diameter 2.5 cm), 95 episodes of local swelling (31.1%; median of maximal diameter 3 cm), and 27 episodes of local pain (8.8%). Four subjects reported itching at the injection site with a total of 30 episodes (9.8%). Median eNO increase after autovaccination was significantly smaller (from 27.3 to 33.8 ppb; p = 0.334) compared to initial values (from 32.6 to 42.2 ppb; p = 0.046) (p = 0.034). We observed no serious adverse events. All organ functions (inclusive electrocardiogramm) and laboratory testing of the blood (clinical chemistry, hematology) and the urine (screening test, Β-microglobuline) were within normal limits. Vital signs undulated within the physiological variability.</p> <p>Conclusion</p> <p>The administration of autologous autovacine for the treatment of house dust mite asthma resulted in a reduction of the eNO increase upon bronchial mite challenge. In nine subjects and 306 injections, only a few mild local reactions and no systemic severe adverse events were observed.</p> <p>Trial registration</p> <p><b>EudraCT Nr</b>. 2005-005534-12</p> <p><b>ClinicalTrials.gov ID </b><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=677209">NCT00677209</a></p>