Effect of intensive treatment for schistosomiasis on immune responses to vaccines among rural Ugandan island adolescents: randomised controlled trial protocol A for the 'POPulation differences in VACcine responses' (POPVAC) programme.
Effect of intensive treatment for schistosomiasis on immune responses to vaccines among rural Ugandan island adolescents: randomised controlled trial protocol A for the 'POPulation differences in VACcine responses' (POPVAC) programme.
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血吸虫病强化治疗对乌干达农村青少年疫苗免疫应答的影响：“疫苗应答的人群差异”（POPVAC）计划的随机对照试验方案A。
DOI：
10.1136/bmjopen-2020-040426
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发表时间：
2021-02-16
期刊：
影响因子：
2.9
通讯作者：
POPVAC trial team principal investigator
中科院分区：
文献类型：
--
作者：
Nkurunungi G;Zirimenya L;Nassuuna J;Natukunda A;Kabuubi PN;Niwagaba E;Oduru G;Kabami G;Amongin R;Mutebe A;Namutebi M;Zziwa C;Amongi S;Ninsiima C;Onen C;Akello F;Sewankambo M;Kiwanuka S;Kizindo R;Kaweesa J;Cose S;Webb E;Elliott AM;POPVAC trial team;POPVAC trial team principal investigator
在低收入国家和高收入国家，以及在农村和城市环境中，几种已获许可的疫苗和研究中的疫苗的效力较低，并诱导免疫应答受损。了解这些人群差异对于优化疫苗在热带地区的有效性至关重要。我们认为，反复暴露于慢性蠕虫感染和免疫调节部分解释了疫苗反应的人群差异。我们设计了一项单独随机、平行组试验，对比吡喹酮（PZQ）强化与标准干预对血吸虫病的影响，以确定对乌干达曼氏血吸虫病流行的农村岛屿学龄青少年（9-17岁）疫苗应答结果的影响。待研究的疫苗包括在“零”天接种卡介苗;在第4周接种黄热病、口服伤寒和人乳头瘤病毒（HPV）疫苗;在第28周接种HPV和破伤风/白喉加强疫苗。强化组将在BCG免疫接种前接受三次PZQ剂量，每隔2周，然后在第8周和此后每季度接受一次剂量。标准组将在第8周和第52周接受PZQ。我们预计将招募480名参与者，其中80%感染了S。曼森一开始主要结果是BCG免疫后8周的BCG特异性干扰素-γ ELISpot应答，以及对于其他疫苗，免疫后4周对关键疫苗抗原的抗体应答。二次分析将确定强化驱虫治疗对保护性免疫相关性、疫苗应答减弱、初免与加强免疫以及S。曼森感染状况和强度。使用存档样本的探索性免疫学测定将能够评估蠕虫和疫苗应答之间的机制联系。已获得乌干达和英国相关伦理委员会的伦理批准。研究结果将与乌干达卫生部、相关区议会、社区领袖和研究参与者分享。将通过会议记录和出版物进一步传播。ISRCTN60517191。
Several licensed and investigational vaccines have lower efficacy, and induce impaired immune responses, in low-income versus high-income countries and in rural, versus urban, settings. Understanding these population differences is essential to optimising vaccine effectiveness in the tropics. We suggest that repeated exposure to and immunomodulation by chronic helminth infections partly explains population differences in vaccine response. We have designed an individually randomised, parallel group trial of intensive versus standard praziquantel (PZQ) intervention against schistosomiasis, to determine effects on vaccine response outcomes among school-going adolescents (9–17 years) from rural Schistosoma mansoni-endemic Ugandan islands. Vaccines to be studied comprise BCG on day ‘zero’; yellow fever, oral typhoid and human papilloma virus (HPV) vaccines at week 4; and HPV and tetanus/diphtheria booster vaccine at week 28. The intensive arm will receive PZQ doses three times, each 2 weeks apart, before BCG immunisation, followed by a dose at week 8 and quarterly thereafter. The standard arm will receive PZQ at week 8 and 52. We expect to enrol 480 participants, with 80% infected with S. mansoni at the outset. Primary outcomes are BCG-specific interferon-γ ELISpot responses 8 weeks after BCG immunisation and for other vaccines, antibody responses to key vaccine antigens at 4 weeks after immunisation. Secondary analyses will determine the effects of intensive anthelminthic treatment on correlates of protective immunity, on waning of vaccine response, on priming versus boosting immunisations and on S. mansoni infection status and intensity. Exploratory immunology assays using archived samples will enable assessment of mechanistic links between helminths and vaccine responses. Ethics approval has been obtained from relevant ethics committes of Uganda and UK. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications. ISRCTN60517191.
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影响因子：
3.2
作者：
Corstjens PL;Nyakundi RK;de Dood CJ;Kariuki TM;Ochola EA;Karanja DM;Mwinzi PN;van Dam GJ
通讯作者：
van Dam GJ
DOI：
10.1126/science.aad5872
发表时间：
2016-01-15
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Pfeiffer JK;Virgin HW
通讯作者：
Virgin HW
影响因子：
168.9
作者：
Black, GF;Weir, RE;Dockrell, HM
通讯作者：
Dockrell, HM
影响因子：
3.1
作者：
Brandt, L;Cunha, JF;Andersen, P
通讯作者：
Andersen, P
影响因子：
5.5
作者：
Elias, Daniel;Britton, Sven;Akuffo, Hannah
通讯作者：
Akuffo, Hannah