Phase IIb Study on the Safety and Efficacy of BM32, a Recombinant Hypoallergenic Vaccine for Immunotherapy of Grass Pollen Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biomay AG
- 入组人数
- 181
- 试验地点
- 21
- 主要终点
- Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
研究概览
简要总结
The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.
详细描述
The present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. After patient assessment during a screening season, patients will be randomized to one of two doses of BM32 or placebo. Patients will receive three injections of BM32 pre-season and one post-season boost injection to maintain optimal allergen specific IgG responses. Outcome will be measured after both seasons individually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of grass pollen allergy
- •Positive skin prick test reaction to grass pollen extract
- •Grass pollen specific IgE and rPhl p 1/rPhl p 5 specific IgE (>3 kUA/L)
- •Moderate to severe symptoms of grass pollen allergy during pollen peak
排除标准
- •Symptomatic perennial allergies
- •Atopic dermatitis
- •Pregnancy or breast feeding
- •Women with childbearing potential not using medically accepted birth control
- •Autoimmune diseases, immune defects, immune suppression
- •Immune complex induced immunopathies
- •Contra indications for adrenaline
- •Severe general maladies, malignancies
- •Patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs
- •Contra indication for skin prick testing
- •Bronchial asthma not controlled by low dose inhaled corticosteroids
- •Chronic use of beta blockers
- •Participation in another clinical trial within one month prior to study
- •Participation in SIT trial in 2 years prio to study
- •Patients who had a previous grass pollen SIT
- •Risk of non-compliance with study procedures
- •Use of prohibited medications
- •Depot corticosteroids - 12 weeks prior to enrolment
- •Oral corticosteroids - 8 weeks prior to enrolment
- •High dose inhaled corticosteroids - 4 weeks prior to enrolment
- •Use of H1 antihistamines 3 days prior to enrolment
研究组 & 干预措施
Placebo
7 subcutaneous injections over a time span of two pollen seasons
干预措施: Placebo (Biological)
结局指标
主要结局
Mean daily combined symptom medication score (SMS)during the peak of the pollen season.
时间窗: Up to 3 months
The score will be recorded daily for the 30-45 days with the highest pollen count in each center
次要结局
- Mean daily symptom score (SS) and medication score (MS) during the peak pollen season and the whole pollen season(Up to 8 months)
- Safety Laboratory: Blood biochemistry(Up to 22 months)
- Number of symptom-free days during the peak pollen season and the whole pollen season(Up to 8 months)
- Rhinoconjunctivitis quality of life evaluation by RQLQ questionnaire during pollen season(Approx. 22 months)
- Results of physical examination(up to 22 months)
- Vital functions(Up to 22 months)
- Mean daily symptom and medication score during the whole pollen season(Up to 8 months)
- Safety laboratory hematology(up to 22 months)
- Meal level of "well-being" measured by a visual analog scale (VAS) during grass pollen season(Up to 8 months)
- Mean allergy specific IgG and IgE antibodies before and after vaccination(Up to 16 months)
- Number of "bad days" during the peak pollen season and the whole pollen season(Up to 8 months)
- Mean asthma score during pollen season(Up to 8 months)
- Skin reactivity to grass pollen extract by titrated skin prick testing(Up to 15 months)
- Safety laboratory: Urine analysis(up to 22 months)