Simon Jakub K, Pasetti Marcela F, Viret Jean-François, Mischler Robert, Muñoz Alma, Lagos Rosanna, Levine Myron M, Campbell James D
Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Hum Vaccin. 2007 Mar-Apr;3(2):54-8. doi: 10.4161/hv.3.2.3877. Epub 2007 Mar 10.
Despite the availability of a safe and effective vaccine for over four decades, measles remains one of the most common infectious disease killers of children in the world. Mucosal administration of currently licensed measles vaccine has been proposed to address issues of needle safety and improve vaccine uptake.
Healthy adult volunteers were randomized to receive live-attenuated monovalent measles virus vaccine (Moraten Berna) via the standard subcutaneous (SQ) or the experimental intranasal (IN) route in a randomized, double-masked fashion. Safety, reactogenicity, immunogenicity, and shedding were assessed.
Safety, reactogenicity, and viral shedding were not significantly different in the two study groups. Immunogenicity was markedly lower in the group of volunteers that received vaccine via the IN route. Plaque reduction neutralization (PRN) geometric mean titers (GMT) were 125 (95% confidence interval [CI] 68-228) milli International Units per milliliter (mIU/mL) on day 28 in recipients of IN vaccine versus 645 (95% CI 468-889) mIU/mL in recipients of vaccine SQ; p< 0.001 by Mann-Whitney Rank Sum. 50% of measles non-immune individuals mounted titers above the protective threshold of PRN 200 mIU/mL after IN administration versus 100% of volunteers who received the vaccine SQ.
Intranasal administration of live-attenuated measles vaccine was safe and well tolerated, but failed to mount significant immune responses when compared to subcutaneous administration. It is possible that higher doses or smaller particle size are necessary for successful intranasal measles vaccination and boosting.
尽管四十多年来一直有安全有效的麻疹疫苗，但麻疹仍是全球儿童最常见的传染病杀手之一。有人提议通过黏膜途径接种目前已获许可的麻疹疫苗，以解决针头安全问题并提高疫苗接种率。
健康成年志愿者被随机分组，以随机、双盲方式通过标准皮下注射（SQ）或实验性鼻内注射（IN）途径接种减毒活单价麻疹病毒疫苗（莫拉坦·伯纳）。评估安全性、反应原性、免疫原性和病毒排出情况。
两个研究组的安全性、反应原性和病毒排出情况无显著差异。通过鼻内途径接种疫苗的志愿者组免疫原性明显较低。接种鼻内疫苗的受试者在第28天时，蚀斑减少中和（PRN）几何平均滴度（GMT）为每毫升125（95%置信区间[CI]68 - 228）毫国际单位（mIU/mL），而接种皮下疫苗的受试者为645（95%CI 468 - 889）mIU/mL；经曼-惠特尼秩和检验，p < 0.001。接种鼻内疫苗后，50%的麻疹非免疫个体产生的滴度高于PRN 200 mIU/mL的保护阈值，而接种皮下疫苗的志愿者这一比例为100%。
鼻内接种减毒活麻疹疫苗安全且耐受性良好，但与皮下接种相比，未能引发显著的免疫反应。对于成功进行鼻内麻疹疫苗接种和加强免疫，可能需要更高剂量或更小的颗粒大小。
