Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Consistency of High Threshold Reactivity
研究概览
简要总结
This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.
详细描述
The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).
Clinical Objective:
To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-
- •Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
- •Willingness to sign consent (or for parent/guardian to sign consent).
- •Willingness to sign the assent form, if consent provided by parent/guardian.
排除标准
- •History of severe anaphylaxis
- •Severe or Moderate asthma
- •Poorly controlled asthma
- •Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
- •Inability to cooperate with and/or perform oral food challenge procedures
- •Primary Immune Deficiency
- •Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
- •Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
- •Use within the past 6 months of other systemic immunomodulatory treatments
- •Clinical signs or symptoms of anemia
- •Hematocrit <0.36 for adult females or <0.38 for adult males
- •Hematocrit <0.34 for children 7-18 years of age
- •Weight <23 kg
研究组 & 干预措施
Low dose challenge passed
Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial
干预措施: Peanut flour (Drug)
Low dose challenge passed
Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial
干预措施: Toasted oat flour (Other)
结局指标
主要结局
Consistency of High Threshold Reactivity
时间窗: 4 weeks
The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted \>443 cumulative total dose on repeat challenge
次要结局
未报告次要终点
研究者
Wayne G. Shreffler, MD, PhD
Director, Food Allergy Center
Massachusetts General Hospital