The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite (FIAVS)

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00677209
First received: May 12, 2008
Last updated: December 28, 2010
Last verified: May 2008

May 12, 2008
December 28, 2010
July 2006
August 2008   (final data collection date for primary outcome measure)
  • Patients' clinical parameters and behaviour, laboratory values [ Time Frame: jul 2006 - august 2008 ] [ Designated as safety issue: Yes ]
  • laboratory testing reflecting function of bone marrow, liver, kidney [ Time Frame: jul 2006- august 2008 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00677209 on ClinicalTrials.gov Archive Site
Lung function,exhalative NO [ Time Frame: jul 2006 - oct 2007 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite
Frankfurt Investigator-initiated Autovaccine-study

House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".

see above

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergens, House Dust Mites
Biological: Injection of autovaccine (Autovaccine Symbiopharm)
increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
Other Name: Autovaccine Symbiopharm
Active Comparator: A
house dust mite allergics will undergo autovaccine immunization
Intervention: Biological: Injection of autovaccine (Autovaccine Symbiopharm)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
December 2010
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • informed consent
  • age 18-35 years
  • known allergy on house-dust mite
  • GINA 0-1

Exclusion Criteria:

  • anamnestic incompatibility to parts of autovaccine
  • asthma > GINA I°
  • chronic disease conditions or infections
  • pregnancy
  • inhalative or systemic steroid use
  • any immunosuppressive therapy
  • intake of any other probiotic medication (e.g. E.coli nissle 1917)
  • participation in any other study at the same time
  • substance abuse
  • Incapability of understanding the study's purpose and performance
  • smoker
Both
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00677209
AVH-2004/1, Eudra-CT Nr. 2005-005534-12
Yes
Prof Stefan Zielen, Childrens Hospital Goethe University
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of pulmonology
Johann Wolfgang Goethe University Hospitals
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP