Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic
      Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and
      also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a
      vaccine that works by exposing your immune system to something that resembles birch. This
      vaccine may help to lessen your allergy symptoms during the natural birch season.
    

Detailed description: 
      Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against
      proteins and glycoproteins from plants, insects, animals and fungi, most of which are
      normally considered harmless. The cross-linking of specific IgE antibodies on effector cells
      by allergens activates an immunological cascade leading to the symptoms of Type I allergy
      including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the
      most common chronic atopic disease and is associated with considerable cost and co-morbidity.
      Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is
      characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery,
      red eyes.

      Recombinant preparations offer various advantages over those based on natural allergen
      extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical
      quality; proteins are molecularly defined thus ensuring product consistency and minimising
      problems related to allergen extract standardisation; preparations only include those
      proteins that are considered relevant for specific immunotherapy; the risk of contamination
      with other allergenic material is excluded; the whole production process can be designed to
      exclude any risk factors for the introduction of infectious agents; the relative dosages of
      individual components of a final preparation can be optimised to favour better clinical
      efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by
      altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and
      decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance
      beneficial immune responses. The investigational product has demonstrated efficacy and good
      tolerability in one previous pivotal Phase III and two previous Phase II studies.
    

Intervention name(s): Placebo; rBet v1-FV; rBet v1-FV; rBet v1-FV; rBet v1-FV
Intervention type(s): Drug; Biological; Biological; Biological; Biological
Intervention description(s): The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.; The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.; The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.; The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.; The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
Other intervention name(s): Comparator; Specific Immunotherapy; Spicific Immunotherapy; Specific Immunotherapy; Spicific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Specific immunotherapy; SIT; SCIT; recombinant