ACELLULAR PERTUSSIS COMBINED WITH DIPHTHERIA AND TETANUS VACCINES

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目的：确定在既往有广泛肿胀反应(ESR)史的儿童中，两种授权疫苗在儿童出现5厘米肿胀或整个上肢肿胀的比例上是否存在差异。比较白喉毒素、破伤风毒素和常见百日咳抗原(百日咳毒素、百日咳毒素和丝状血凝素)的血清反应率和免疫球蛋白(GMC)与5剂后无肿胀反应或轻度(2厘米)肿胀反应的儿童之间的血清反应率和GMC。红斑(任何，轻度，中度，重度)：疼痛(任何，轻度，中度，重度)；肿胀(任何，轻度，中度，重度)；硬结(存在，不存在)。探讨血沉发生率与体重指数(BMI)的关系。志愿者：300名儿童(斯坦福大学的50名)在蹒跚学步的孩子服用DTAP后出现严重的局部反应，他们将在7个临床免疫安全评估(CISA)中心之一参加这项研究。他们将被同样随机地接种两种许可的DTAP疫苗(Infanrix或DAPTACEL)中的一种，并在接种后跟踪4天，以了解局部和全身反应的发生和分级。在接种前和接种后1个月采静脉血检测白喉毒素、破伤风毒素和常见百日咳抗原(百日咳毒素、百日咳毒素和丝状血凝素)的免疫球蛋白。志愿者参与：志愿者将使用一根23英寸的针在左侧三角区接种两种DTAP疫苗中的一种。家长们将获得一个数字温度计，并教他们如何使用它。他们还将配备专门的尺子装置来测量肢体周长。在接种疫苗后的4天内，家长将被要求在日记卡上记录晚上的口腔温度和评分一般活动。家长将连续14天每天晚上检查实验疫苗的注射部位，并记录每个注射部位以下局部反应的严重程度：疼痛、手臂功能评估、红肿、局部肿胀、瘙痒、发热、硬结和四肢周长。研究护士将在接种疫苗后第2天、第5天和第15天打电话给家人收集安全数据。志愿者将在接种疫苗四到六周后返回诊所进行抽血，以比较免疫球蛋白血清反应。要调查的变量：1)确定有广泛局部反应病史的儿童服用5DTaP后肿胀反应的发生率和严重程度。2)确定在第4次接种后出现广泛肿胀反应的儿童，在第5次接种不同许可的DTAP疫苗后，肿胀反应的发生率和严重程度是否有显著差异。3)比较接种后有和无广泛肿胀反应的儿童对疫苗成分的免疫球蛋白血清反应5.风险/益处：参与这项研究的风险是那些已知存在的接种DTAP的风险和那些抽血的风险。志愿者的好处是对白喉、破伤风和百日咳有潜在的保护作用。对社会的好处是确定一种疫苗产生的广泛肿胀反应是否比另一种少。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: To determine among children with a prior history of extensive swelling reactions (ESR) whether there is a difference between licensed vaccines in the proportion children experiencing > 5 cm of swelling or entire upper limb swelling. To compare seroresponse rates and GMC of IgG to diphtheria toxin, tetanus toxin, and common pertussis antigens (pertussis toxin, pertactin and filamentous hemagglutinin) between children who experience post-dose 5 ESR and children with no, or mild (<2 cm) swelling reaction post-dose 5. To determine the rate of and severity of ESR post-dose 5 DTaP in children who have a history of extensive local reaction post-dose 4. To compare between vaccines rates of other reactions (Fever: T>38C, T>39C, T>40C; erythema (any, mild, moderate, severe): pain (any, mild, moderate, severe); swelling (any, mild, moderate, severe); induration (present, absent). To explore the association of rate of ESR with body mass index (BMI). Volunteers: Three hundred children (50 at Stanford) who have experienced a severe local reaction after their toddler dose of DTaP will be enrolled into the study at one of the 7 Clinical Immunization Safety Assessment (CISA) Centers. They will be equally randomized to receive one of two licensed DTaP vaccines (Infanrix or DAPTACEL) and followed for 4 days after vaccination for the occurrence and grading of local and systemic reactions. Venous blood will be drawn immediately before and one month after vaccination for measurement of IgG to diphtheria toxin, tetanus toxin, and common pertussis antigens (pertussis toxin, pertactin, and filamentous hemagglutinin). Volunteer Participation: Volunteers will be receive one of two vaccines of DTaP in the left deltoid using a 23 gauge 1 inch needle. Parents will be given a digital thermometer and tuaght how to use it. They will also be provided with a special ruler device for measuring limb circumference. For 4 days following vaccination, parents will be asked to record on a diary card an evening oral temperature and grade general activity. Each evening, for 14 days, the parent will examine the site of injection of the experimental vaccine and record the presence of severity of the following local reactions for each injection site: pain, functional assessment of the arm, redness, local swelling, pruritis, warmth, induration, and limb circumference. The study nurse will phone the family on days 2, 5, and 15 post-vaccination to collect the safety data. Volunteers will return to clinic four to six weeks after vaccination for a blood draw that will compare IgG seroresponses. Variables to be Investigated: 1) To determine rates and severity of swelling reactions post-dose 5 DTaP in children who have a prior history of extensive local reaction. 2) To determine if there are significant differences in rates and severity of swelling reactions following the 5th dose of different licensed DTaP vaccines in children who experienced an extensive swelling reaction after the 4th toddler dose. 3) To compare IgG seroresponses to vaccine components in children who do and do not have extensive swelling reactions post-dose 5. Risks/Benefits: The risk of participating in this study are those known to exist for vaccination with DTaP and those of blood draw. The benefit to the volunteer is potential protection against diphtheria, tetanus, and pertussis. The benefit to society is to determine if one vaccine produces fewer extensive swelling reactions than the other.