Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen
详细描述
In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
- •Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT
排除标准
- •received immunotherapy against any allergen within 3 years before the start of the study.
- •symptomatic to perennial allergens or active seasonal allergy during the trial.
- •non controlled asthma (peak flow lower than 30% of predicted value).
- •history of any severe medical condition able to influence the course of the study
- •Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
- •Subjects under immunosuppressive medication.
- •Pregnant or lactating women or women willing or intending to become pregnant during the study.
- •Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study
研究组 & 干预措施
AllerT SC
AllerT subcutaneous injections
干预措施: AllerT SC (Drug)
Placebo SC
placebo subcutaneous injections
干预措施: Placebo SC (Drug)
AllerT ID
AllerT intra-dermal injections
干预措施: AllerT ID (Drug)
Placebo ID
placebo intra-dermal injections
干预措施: Placebo ID (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 84 days
collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)
次要结局
- change from baseline in blood levels of specific IgG4 and IgE(after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months)
- change from baseline in nasal provocation tests(84 days)