冈比亚的麻疹和红疹疫苗微针贴片:一个1/2阶段,双盲,双模拟,随机,主动控制,年龄降低试验
Ikechukwu Adigweme1, Mohammed Yisa1, Michael Ooko1
1Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.
Lancet (London, England)
|May 2, 2024
概括
微针贴片 (MNPs) 提供了一种有前途的新方法来接种麻疹和红疹疫苗 (MRV). 这项试验发现MRV-MNP在儿童中是安全和免疫的,支持其进一步发展.
科学领域:
- 疫苗学和免疫学
- 儿童传染病
- 微针技术
背景情况:
- 微针贴片 (MNP) 是提高低收入和中等收入国家的免疫水平的优先创新.
- 麻疹和风疹疫苗 (MRV) 对儿童健康至关重要,但传统的疫苗接种方式面临挑战.
- 这项研究提供了儿童通过MNP输送的MRV耐受性,安全性和免疫性的初步数据.
研究的目的:
- 在不同儿童年龄组评估新型麻疹和红疹疫苗微针贴片 (MRV-MNP) 的安全性和耐受性.
- 通过测量对麻疹和红疹的抗体反应来评估MRV-MNP的免疫性.
- 将MRV-MNP的安全性和免疫性与标准的皮下注射MRV进行比较.
主要方法:
- 在冈比亚进行了单中心,1/2期,双盲,随机,主控试验.
- 参与者 (婴儿,幼儿,成年人) 接受了MRV- MNP与安慰剂注射或安慰剂- MNP与MRV皮下注射 (MRV- SC).
- 通过180天的不良事件来评估安全性;免疫性通过基线,第42天和第180天的血清抗体水平来测量.
主要成果:
- 在接种疫苗后的头14天内,在任何年龄组中都没有发现安全问题.
- 在婴儿中,MRV-MNP显示出高血清转化率:麻疹的93%和红疹的100%,与MRV-SC相比.
- 应用部位的轻微局部反应和皮肤变色是最常见的事件;没有报告严重的不良事件.
结论:
- 麻疹和红疹疫苗微针贴片 (MRV-MNP) 是安全的,在婴儿和幼儿中耐受良好.
- 在婴儿中,MRV-MNP引发了强大的免疫反应,支持其作为替代疫苗输送方法的潜力.
- 这些发现支持全球免疫计划的MRV-MNP的加速开发和潜在实施.
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