title: Safety, tolerability, and impact on allergic inflammation of autologous E.coli autovaccine in the treatment of house dust mite asthma--a prospective open clinical trial.
abstract: BACKGROUND
  Asthma is increasing worldwide and results from a complex immunological interaction between genetic susceptibility and environmental factors. Autovaccination with E. coli induces a strong TH-1 immune response, thus offering an option for the treatment of allergic diseases.
  
  
  METHODS
  Prospective open trial on safety, tolerability, and impact on allergic inflammation of an autologous E.coli 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EudraCT Nr. 2005-005534-12ClinicalTrials.gov ID NCT00677209.
authors.affiliation: Dpt of Allergy, Pulmonology, and Cystic Fibrosis, Children's and Adolescents' Hospital, Goethe University, Theodor Stern Kai 7, 60590 Frankfurt, Germany. Markus.Rose@kgu.de
authors.forename: Markus A
authors.initials: MA
authors.lastname: Rose
authors.forename: Bianca
authors.initials: B
authors.lastname: Weigand
authors.forename: Ralf
authors.initials: R
authors.lastname: Schubert
authors.forename: Johannes
authors.initials: J
authors.lastname: Schulze
authors.forename: Stefan
authors.initials: S
authors.lastname: Zielen
mesh_terms: D000328:Adult; D000818:Animals; D001249:Asthma / Q000150:complications / Q000276:immunology*; D054991:Autovaccines; D004487:Edema / Q000209:etiology; D004890:Erythema / Q000209:etiology; D004926:Escherichia coli / Q000276:immunology*; D005260:Female; D006801:Humans; D007249:Inflammation / Q000209:etiology / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000037:antagonists & inhibitors*; D010146:Pain / Q000209:etiology; D011446:Prospective Studies; D011537:Pruritus / Q000209:etiology; D039981:Pyroglyphidae / Q000276:immunology*; D012867:Skin / Q000276:immunology; D012882:Skin Tests; D018417:Th1 Cells; D014611:Vaccination / Q000009:adverse effects; D055986:Vital Signs / Q000276:immunology; D055815:Young Adult
chemical_list: D054991:Autovaccines; D009569:Nitric Oxide