A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II STUDY TO ASSESS THE

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 巨细胞病毒（CMV）是先天性感染的婴儿和免疫功能低下的儿童和成人，特别是人类免疫缺陷病毒（HIV）感染的个体和移植受者的发病率和偶尔死亡率的重要原因。 新生儿也是一个特别高风险的群体。 在青少年人群中接种CMV疫苗最终可以改善妊娠结局，即使它本身不能预防感染。 主要目的是评估注射3剂CMV gB/MF 59疫苗是否会减少健康CMV血清阴性青少年女性发生全身性CMV感染。第一部分将入组约2400例年龄为12 - 17岁（初始入组时）的健康女性，以获得350例CMV血清阴性受试者用于疫苗试验。 受试者将按照0、1和6个月的时间表，通过三角肌IM注射接受3剂疫苗或生理盐水安慰剂。开发CMV疫苗的最重要原因是预防先天性CMV疾病。预防先天性巨细胞病毒的一种策略是在性活动开始之前对青春期女孩或男孩和女孩进行免疫接种，因为性活动显然是婴儿期和幼儿期后的一种重要传播方式。 该试验旨在检查CMV疫苗可能的目标人群中的疫苗。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Cytomegalovirus (CMV) is an important cause of morbidity and occasional mortality in congenitally infected infants and immunocompromised children and adults, especially human immunodeficiency virus (HIV)-infected individuals and transplant recipients. Newborn infants represent a particularly high-risk group as well. CMV vaccine in an adolescent population could ultimately improve pregnancy outcomes, even if it does not prevent infection per se. The main objective is to assess whether injection with 3 doses of the CMV gB/MF59 vaccine will reduce the acquisition of a systemic CMV infection in healthy CMV-seronegative adolescent females. Approximately 2400 healthy females age 12 to 17 years (at time of initial enrollment) will be enrolled into the first part in order to obtain 350 CMV-seronegative subjects for the vaccine trial. Subjects will receive 3 doses of vaccine or saline placebo administered by IM injection in the deltoid muscle on a 0-, 1-, and 6-month schedule. The most important reason for developing a CMV vaccine is to prevent congenital CMV disease. One strategy for the prevention of congenital CMV would be to immunize adolescent girls, or perhaps both boys and girls, before the onset of sexual activity as sexually activity is clearly an important mode of transmission after infancy and the toddler years. The trial is designed to examine the vaccine in a likely target population for a CMV vaccine.