Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00554983

Enrollment

255

Registered

2007-11-07

Start date

2007-09-30

Completion date

2012-05-31

Last updated

2013-11-08

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

Conditions

Allergy

Keywords

Recombinant birch pollen allergy, IgE-mediated allergic disease attributed to birch pollen

Brief summary

Efficacy and Safety from a recombinant folding variant of Bet v 1

Interventions

BIOLOGICALrecombinant birch pollen allergen

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

BIOLOGICALplacebo

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Allergic rhinoconjunctivitis attributable to birch pollen * Positive SPT * Positive EAST * Positive specific provocation test

Exclusion criteria

* Serious chronic diseases * Other perennial allergies

Design outcomes

Primary

Measure	Time frame
Symptom-Medication-Score	during pollen season

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026