Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.
Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.
复制标题
DOI：
10.1016/j.vaccine.2015.11.056
复制
发表时间：
2016-01-12
期刊：
影响因子：
5.5
通讯作者：
Bellamy AR
中科院分区：
文献类型：
--
作者：
Bernstein DI;Munoz FM;Callahan ST;Rupp R;Wootton SH;Edwards KM;Turley CB;Stanberry LR;Patel SM;Mcneal MM;Pichon S;Amegashie C;Bellamy AR
巨细胞病毒（CMV）是先天性感染的主要原因，也是疫苗开发的重要靶点。12 - 17岁的CMV血清阴性女孩在0、1和6个月时接受CMV糖蛋白B（gB）疫苗与MF 59或生理盐水安慰剂。在整个研究期间采集血液和尿液，以根据PCR和/或血清转化为非疫苗CMV抗原获得CMV感染的证据。402例CMV血清阴性受试者接种疫苗（195例疫苗，207例安慰剂）。疫苗总体耐受性良好，但局部和全身不良事件在疫苗组中明显更常见。疫苗在所有疫苗接种者中诱导gB抗体，3次接种后gB几何平均滴度为13，400 EU; 95%CI 11，436，15，700。总体而言，检测到48例CMV感染（21例疫苗，27例安慰剂）。在符合方案人群（124例疫苗，125例安慰剂）中，疫苗有效性为43%; 95%CI：-36; 76，P = 0.20。最显著的差异发生在按照方案接种2剂后;疫苗有效性为45%，95%CI：-9; 72，P = 0.08。该疫苗是安全和免疫原性。尽管疗效未达到常规显著性水平，但结果与先前使用相同制剂在成年女性中进行的研究（Pass et al NEJM 360：1191，2009）一致。
Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development. CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens. 402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95% CI: −36; 76, P=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95% CI: −9; 72, P=0.08. The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al NEJM 360:1191, 2009) using the same formulation.