NCT01506375已完成2 期
Safety, Clinical Tolerability and Immunogenicity of gpASIT+TM Administered Subcutaneously to Hay Fever Patients Either Alone or in Presence of DnaK Immunoregulating Adjuvant
BioTech Tools S.A.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety of the treatment
研究概览
简要总结
The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has given written informed consent
- •Age between 18 and 50 years
- •The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- •Male or non-pregnant, non-lactating female
- •Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
- •Allergy diagnosis:
- •A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years
- •A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
- •Specific IgE against grass pollen (IgE > 0.7 kU/l) [using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)]
- •Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011)
排除标准
- •Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
- •Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
- •A history of hypersensitivity to the excipients of investigational products
- •Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
- •Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
- •Subjects with a VC < 80% and a FEV1 < 70% of predicted value at the screening visit
- •Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period
- •Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
- •Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent...)
- •Subjects with a history of renal disease or chronic hepatic disease
- •Subject with malignant disease, autoimmune disease
- •Any chronic disease, which may impair the subject's ability to participate in the trial
- •Subjects requiring beta-blockers medication
- •Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
- •Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial (screening visit)
- •Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial (screening visit)
- •Subject with febrile illness (> 37.5°C, oral)
- •A known positive serology for HIV-1/2, HBV or HCV
- •Subjects that are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
- •Receipt of blood or a blood derivative in the past 6 months preceding trial entry
- •Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
- •Any condition which could be incompatible with protocol understanding and compliance
- •Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
- •Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
- •Subjects without means of contacting the Investigator rapidly in case of emergency, or not able to be contacted rapidly by the Investigator
结局指标
主要结局
Safety of the treatment
时间窗: up to the end of the grass pollen season
Safety will be evaluated by the following parameters: general physical status, vital signs, haematological parameters, general biochemical parameters, solicited local adverse events, all (serious) adverse events, immunological analysis (total IgG and IgE), inflammatory parameters (CRP) and anti-adjuvant mmunoglobulins.
Clinical tolerability of the treatment
时间窗: Duration of treatment period (4 weeks)
The clinical tolerability will by assessed through the solicited local adverse events, all (serious) adverse events and the investigator and subject opinion.
次要结局
- Impact of gpASIT+TM with or without adjuvant on the immunological status of the subjects.(up to 1 year after the start of treatment)
- Impact of gpASIT+TM with or without adjuvant on the grass pollen allergic symptoms of the subjects.(During the pollen season)
- Long-term follow-up of the patients(1 year after the start of treatment)
研究者
研究点 (2)
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