The impact of helminths on the response to immunization and on the incidence of infection and disease in childhood in Uganda: design of a randomized, double-blind, placebo-controlled, factorial trial of deworming interventions delivered in pregnancy and early childhood [ISRCTN32849447]
The impact of helminths on the response to immunization and on the incidence of infection and disease in childhood in Uganda: design of a randomized, double-blind, placebo-controlled, factorial trial of deworming interventions delivered in pregnancy and early childhood [ISRCTN32849447]
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DOI：
10.1177/1740774506075248
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发表时间：
2007-01-01
期刊：
影响因子：
2.7
通讯作者：
Whitworth, James A. G.
中科院分区：
文献类型：
--
作者：
Elliott, Alison M.;Kizza, Moses;Whitworth, James A. G.
背景 蠕虫对免疫反应具有深远的影响，使寄生虫能够长期生存，而对宿主的损害最小。其中一些效应会“溢出”，改变对非蠕虫抗原或过敏原的反应。有人认为，这可能会导致免疫和感染反应受损，同时有助于对抗过敏和自身免疫性疾病中的炎症反应。这些影响可能在子宫内通过暴露于母体蠕虫感染或通过在以后的生活中直接暴露而产生。目的确定妊娠期和幼儿中的蠕虫及其治疗对儿童期免疫和疾病结果的影响。方法该试验对两个人（一名孕妇和她的孩子）进行了两次三项随机、双盲、安慰剂对照干预措施。孕妇随机接受阿苯达唑或安慰剂和吡喹酮或安慰剂。在 15 个月大时，他们的孩子被随机分配服用三个月的阿苯达唑或安慰剂，并持续到 5 岁。建议将这一系列干预措施指定为 2 X 2(X2) 析因设计。儿童接受卡介苗免疫，以预防脊髓灰质炎、白喉、破伤风、百日咳、嗜血杆菌、乙型肝炎和麻疹。主要免疫学结果是在一岁、三岁和五岁时全血细胞因子测定和抗体测定中对卡介苗抗原和破伤风类毒素的反应。主要疾病结果是疟疾、肺炎、腹泻、结核病、麻疹、艾滋病毒垂直传播和特应性疾病发作的发病率，通过门诊就诊和每月两次家访进行测量。还评估了对贫血、生长和智力发育的影响。 结论 这项试验采用了新颖的设计，包括对孕妇及其后代的相关干预措施，是第一个检查蠕虫及其在妊娠和幼儿时期的治疗对免疫、传染病和过敏性疾病结果的影响的试验。研究结果将增进对蠕虫感染的有害和有益影响的了解，并为政策提供信息。
Background Helminths have profound effects on the immune response, allowing long-term survival of parasites with minimal damage to the host. Some of these effects "spill-over", altering responses to non-helminth antigens or allergens. It is suggested that this may lead to impaired responses to immunizations and infections, while conferring benefits against inflammatory responses in allergic and autoimmune disease. These effects might develop in utero, through exposure to maternal helminth infections, or through direct exposure in later life.Purpose To determine the effects of helminths and their treatment in pregnancy and in young children on immunological and disease outcomes in childhood.Methods The trial has three randomized, double-blind, placebo-controlled interventions at two times, in two people: a pregnant woman and her child. Pregnant women are randomized to albendazole or placebo and praziquantel or placebo. At age 15 months their children are randomized to three-monthly albendazole or placebo, to continue to age five years. The proposed designation for this sequence of interventions is a 2 X 2(X2) factorial design.Children are immunized with BCG and against polio, Diphtheria, tetanus, Pertussis, Haemophilus, hepatitis B and measles. Primary immunological outcomes are responses to BCG antigens and tetanus toxoid in whole blood cytokine assays and antibody assays at one, three and five years of age. Primary disease outcomes are incidence of malaria, pneumonia, diarrhoea, tuberculosis, measles, vertical HIV transmission, and atopic disease episodes, measured at clinic visits and twice-monthly home visits. Effects on anaemia, growth and intellectual development are also assessed.Conclusion This trial, with a novel design comprising related interventions in pregnant women and their offspring, is the first to examine effects of helminths and their treatment in pregnancy and early childhood on immunological, infectious disease and allergic disease outcomes. The results will enhance understanding of both detrimental and beneficial effects of helminth infection and inform policy.