randomized double blind placebo controlled study on the efficacy of autologous autovaccine in house dust mite allergy - FIAVS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005534-12-DE

Enrollment

Registered

2005-11-23

Start date

2006-04-18

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic diseases such as rhinoconjunctivitis or bronchial asthma are a major public health burden. The huge associated costs demand an evidence based therapeutic aproach. The only available causative therapy is the specific immuno-therapy (SIT). Auto-vaccine is another biogen substance, which derives from human-GI-tract bacteria. Its subcutaneous administration results in a Th-1 driven shift towards immunotolerance.

Interventions

Trade Name: Autovaccine Product Name: Autovaccine Product Code: none Pharmaceutical Form: Injection* Other descriptive name: autovaccine symbiovaccin Concentration unit: IU/ml international unit(s)/mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: otherwise healthy adults with house dust mite allergy prooven by positive prick test and bronchial provocation (FEV1 decrease > 20%). Episodic bronchial asthma (GINA 0-I°). Informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: allergies towards ingredients of the autovaccine. Bronchial asthma > GINA I°, other chronic diseases. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Proove of concept for the efficacy of autologous autovaccine in the therapy of house dust mite allergy in adults. Determination of exhalative NO (eNO) as a marker of bronchial inflammation. Under the influence of the verum, we expect versus placebo a significant blockade of the synthesis of eNO.;Secondary Objective: Bronchial hyperresponsiveness will be determined by metacholin testing, a routine procedure in clinical praxis. Autovaccine-reated subjects are expected to show a reduced bronchial response towards inhalationof house dust mite-solution. Other markers to assess bronchial inflammation will be sputum eosinophilia, and for systemic inflammation and allergic sensitization the determination of CD63, lipoprotein binding protein, and IgE;Primary end point(s): a significant reduction of eNO in the autovaccine treated group.	—

Measure

Time frame

Main Objective: Proove of concept for the efficacy of autologous autovaccine in the therapy of house dust mite allergy in adults. Determination of exhalative NO (eNO) as a marker of bronchial inflammation. Under the influence of the verum, we expect versus placebo a significant blockade of the synthesis of eNO.;Secondary Objective: Bronchial hyperresponsiveness will be determined by metacholin testing, a routine procedure in clinical praxis. Autovaccine-reated subjects are expected to show a reduced bronchial response towards inhalationof house dust mite-solution. Other markers to assess bronchial inflammation will be sputum eosinophilia, and for systemic inflammation and allergic sensitization the determination of CD63, lipoprotein binding protein, and IgE;Primary end point(s): a significant reduction of eNO in the autovaccine treated group.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026