Impact of Vaccination on Th2 Immunity in Infancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Allergen-specific IgE
研究概览
简要总结
The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.
详细描述
This is a single-site study of infants who are scheduled to receive their third series (~6 month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk, egg, or peanut. Infants will be assigned to one of two groups depending on the infant's sensitization to milk, egg, and peanut.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from parent/guardian
- •General good health without other known need for blood draws that would conflict with the study volume requirements
- •Aged 5 months - 7 months, any race/ethnicity, any gender
- •Subjects must not have yet received their third DTaP vaccination, which typically is given at 6 months of age. Subjects must have previously received two doses of the DTaP vaccination, at ages 2 months and 4 months
- •Willingness to return for follow-up testing as defined in the protocol and consent if screening tests indicate eligibility
- •Group 1 participants must have all of the following:
- •A negative skin prick test to egg, milk, and peanut
- •A negative IgE to egg, milk, and peanut
- •Group 2 participants must have all of the following:
- •A positive family history of allergic disease
- •Atopic Dermatitis not requiring prescription medication
- •A positive IgE to milk, egg, and/or peanut
- •If Group 1 enrollment is completed first, participants must have all of the following to be enrolled in Group 2:
- •A family history of atopy
- •Atopic dermatitis not requiring prescription medication
- •If Group 2 enrollment is completed first, participants must have all of the following to be enrolled in Group 1:
- •No personal or family history of atopic disease
排除标准
- •History of anemia requiring any treatment
- •Previous allergic reaction to any food, defined as itching, rash, hives, swelling, vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing out immediately after food ingestion.
- •Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)
- •Severe atopic dermatitis (liberally defined as requiring prescription medication)
- •Unable to obtain serum sample for determination of egg, milk and peanut IgE levels
- •Use of short-acting anti-histamines (diphenhydramine, etc.) more than one time within 3 days of skin testing or on the day of skin testing
- •Any history of intravenous or oral steroid medication
- •Known underlying immune defect/deficiency or bleeding disorder
结局指标
主要结局
Allergen-specific IgE
时间窗: baseline and day 28
Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint.
次要结局
未报告次要终点