Thysen Sanne M, Jensen Aksel Karl Georg, Rodrigues Amabelia, Borges Igualdino da Silva, Aaby Peter, Benn Christine, Fisker Ane
OPEN, University of Southern Denmark, Odense, Denmark
Research Center of Vitamins and Vaccines, Statens Serum Institut, Copenhagen S, Denmark.
BMJ Open. 2019 Sep 24;9(9):e025724. doi: 10.1136/bmjopen-2018-025724.
The BCG vaccine is designed to protect against tuberculosis, but the vaccine may have broader effects. In 2014, the Strategic Advisory Group of Experts on Immunization reviewed the literature on non-specific effects of BCG, and concluded that the evidence was consistent with beneficial non-specific effects and requested further randomised trials.
Within the Bandim Health Project's urban and rural health and demographic surveillance systems, we will conduct a cluster-randomised trial in six suburban districts and 55 rural villages. Infants are enrolled at a home visit before 72 hours of life. In intervention clusters, children are vaccinated with BCG and oral polio vaccine (OPV). In control clusters, the caregivers are informed about vaccination opportunities. Using Cox-proportional hazards models, we will test whether BCG and OPV provided at a single home visit can reduce early infant mortality up to 60 days.The trial was initiated with a pilot study in Biombo region in June 2015. The trial was scaled up to full study including Oio and Cacheu regions in July 2016. The trial was expanded to include the urban study area in July 2017.
BCG vaccination is delayed in many low-income settings. WHO-recommended home visits are resource demanding and vaccines are not part of the recommendation. Utilising the home visits to provide BCG and OPV may provide countries with a further incentive to introduce a single home visit. In countries, where home visits are already in place, vaccines can easily be added to reduce early infant mortality. The trial is approved by the Guinean Ethical Committee (Reference number: 0016/CNES/INASA/2015) and the Danish Ethics Committee has given its consultative approval. The results of the trial will be published in international peer-reviewed journals.
NCT02504203; Pre-results.
卡介苗旨在预防结核病，但该疫苗可能具有更广泛的作用。2014年，免疫战略咨询专家组审查了卡介苗非特异性作用的文献，并得出结论认为，证据表明存在有益的非特异性作用，并要求进行进一步的随机试验。
在班迪姆健康项目的城乡卫生和人口监测系统中，我们将在6个郊区和55个乡村进行一项整群随机试验。婴儿在出生72小时内的家访时登记入组。在干预组中，儿童接种卡介苗和口服脊髓灰质炎疫苗（OPV）。在对照组中，照顾者被告知接种机会。我们将使用Cox比例风险模型，测试在单次家访时接种卡介苗和OPV是否能将60天内的早期婴儿死亡率降低。该试验于2015年6月在比翁博地区进行了试点研究。2016年7月，该试验扩大到全面研究，包括奥约和卡谢乌地区。2017年7月，该试验扩展到包括城市研究区域。
在许多低收入环境中，卡介苗接种被推迟。世界卫生组织推荐的家访需要资源，且疫苗并非推荐内容的一部分。利用家访提供卡介苗和OPV可能会促使各国更有动力开展单次家访。在已经开展家访的国家，可以轻松添加疫苗以降低早期婴儿死亡率。该试验已获得几内亚伦理委员会批准（参考编号：0016/CNES/INASA/2015），丹麦伦理委员会已给予咨询批准。试验结果将发表在国际同行评审期刊上。
NCT02504203；预结果。
