NCT01445002已完成2 期
Safety and Dose Finding Study Based on the Effects of Three Subcutaneous Injections of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, on Responses to Allergen Challenge by Skin Testing and in the Vienna Challenge Chamber (VCC) as Well as Immunological Response in Subjects Know to Suffer From Grass-pollen Induced Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biomay AG
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen
研究概览
简要总结
The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:
- skin prick testing
- grass pollen inhalation challenge
- antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.
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
- •History of seasonal allergic rhinitis from grass pollen
- •Normal electrocardiogram
- •Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
- •Positive skin prick test for grass pollen at or within 12 months preceding screening visit
- •Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit
排除标准
- •Pregnant or lactating females
- •Females with childbearing potential not using medically acceptable birth control
- •Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
- •Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
- •Current or recent participation in another clinical trial
- •SIT for grass pollen allergy in the last two years prior to study
- •Past or present disease, which may affect outcome of the trial, judged by investigator
- •Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
- •Suspected hypersensitivity to any ingredients of study medication
- •Use of prohibited medication prior to screening and throughout study
- •depot corticosteroids (12 weeks)
- •oral corticosteroids (8 weeks)
- •inhaled corticosteroids (4 weeks)
- •Allergic symptoms at the time of screening
研究组 & 干预措施
Placebo
Placebo Comparator
3 subcutaneous injections over a time span of 8 weeks
干预措施: Placebo (Biological)
BM32 high dose
Experimental
3 subcutaneous injections of BM32 over a time span of 8 weeks
干预措施: BM32 (Biological)
BM32 medium dose
Experimental
3 subcutaneous injections of 20 micrograms in a time span of 8 weeks
干预措施: BM32 (Biological)
BM32 low dose
Experimental
3 subcutaneous injections of 10 micrograms in a time span of 8 weeks
干预措施: BM32 (Biological)
结局指标
主要结局
Minimum effective dose for reduction of total nasal symptom score (TNSS) after inhalation challenge with grass pollen
时间窗: Baseline and 14 weeks
Difference in the total Nasal Symptom Score (TNSS) between spending 6 hrs in the Vienna Challenge Chamber (VCC) at screening and spending 6 hrs in the VCC four weeks after the last subcutaneous injection of BM32.
次要结局
- Minimum Effective dose for reduction of Total Non-Nasal Symptom Score (TNNSS) following inhalation challenge with grass pollen(Baseline and 14 weeks)
- Minimum effective dose for reduction of Global symptom Score upon inhalation challenge with grass pollen(Baseline and 4 weeks after final s.c. injection)
- Minimum effective dose for reduction of nasal airflow resistance after inhalation challenge with grass pollen(Baseline and 14 weeks)
- Minimum effective dose to reduce skin reaction to grass pollen allergen upon skin prick testing(Baseline and 14 weeks)
- Difference in FEV1 and FEV/FVC between screening and completion of vaccination(Baseline and 14 weeks)
- Frequency of local reactions to treatment(average of 8 weeks from 1st to last injection)
- Change in allergy specific total IgG(Baseline and average of 12 weeks after randomization)
- Change in allergy specific IgE(Baseline and average of 12 weeks after randomization)
- Frequency of systemic reactions to treatment(average of 8 weeks from 1st to last injection)
- Severity of local reactions to treatment(Average of 8 weeks from 1st to last injection)
- Severity of systemic reactions to treatment(Average of 8 weeks from 1st to last injection)
- Frequency of adverse events(average of 14 weeks from 1st injection)
研究者
研究点 (1)
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