Vaccine prevention of maternal cytomegalovirus infection.
Vaccine prevention of maternal cytomegalovirus infection.
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DOI：
10.1056/nejmoa0804749
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发表时间：
2009-03-19
期刊：
影响因子：
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通讯作者：
Cloud G
中科院分区：
文献类型：
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作者：
Pass RF;Zhang C;Evans A;Simpson T;Andrews W;Huang ML;Corey L;Hill J;Davis E;Flanigan C;Cloud G
先天性巨细胞病毒（CMV）感染是新生儿听力、认知和运动障碍的重要原因。在这项2期、安慰剂对照、随机、双盲试验中，我们评价了由重组CMV包膜糖蛋白B和MF 59佐剂组成的疫苗与安慰剂的比较。CMV血清阴性的妇女在分娩后1年内分别在0、1和6个月时接种3剂CMV疫苗或安慰剂。我们在42个月的时间里，每季度检测一次妇女的CMV感染，使用的是针对CMV蛋白而不是糖蛋白B的IgG抗体检测。通过病毒培养或免疫印迹证实感染。主要终点是检测到CMV感染的时间。我们随机分配234名受试者接受CMV疫苗，230名受试者接受安慰剂。由于疫苗有效性，计划的中期分析导致了停止建议。经过至少1年的随访，有49例确诊感染，其中疫苗组18例，安慰剂组31例。Kaplan-Meier分析显示，疫苗组在42个月期间比安慰剂组更有可能保持未感染（P = 0.02）。根据每100人-年的感染率，疫苗有效性为50%（95%置信区间，7 - 73）。受试者婴儿中的1例先天性感染发生在疫苗组，3例感染发生在安慰剂组。疫苗组的局部反应（疼痛、红斑、硬结和发热）和全身反应（寒战、关节痛和肌痛）多于安慰剂组。CMV糖蛋白B疫苗有可能减少母体和先天性CMV感染的发生病例。（ClinicalTrials.gov编号，NCT 00125502。）
Congenital infection with cytomegalovirus (CMV) is an important cause of hearing, cognitive, and motor impairments in newborns. In this phase 2, placebo-controlled, randomized, double-blind trial, we evaluated a vaccine consisting of recombinant CMV envelope glycoprotein B with MF59 adjuvant, as compared with placebo. Three doses of the CMV vaccine or placebo were given at 0, 1, and 6 months to CMV-seronegative women within 1 year after they had given birth. We tested for CMV infection in the women in quarterly tests during a 42-month period, using an assay for IgG antibodies against CMV proteins other than glycoprotein B. Infection was confirmed by virus culture or immunoblotting. The primary end point was the time until the detection of CMV infection. We randomly assigned 234 subjects to receive the CMV vaccine and 230 subjects to receive placebo. A scheduled interim analysis led to a stopping recommendation because of vaccine efficacy. After a minimum of 1 year of follow-up, there were 49 confirmed infections, 18 in the vaccine group and 31 in the placebo group. Kaplan-Meier analysis showed that the vaccine group was more likely to remain uninfected during a 42-month period than the placebo group (P = 0.02). Vaccine efficacy was 50% (95% confidence interval, 7 to 73) on the basis of infection rates per 100 person-years. One congenital infection among infants of the subjects occurred in the vaccine group, and three infections occurred in the placebo group. There were more local reactions (pain, erythema, induration, and warmth) and systemic reactions (chills, arthralgias, and myalgias) in the vaccine group than in the placebo group. CMV glycoprotein B vaccine has the potential to decrease incident cases of maternal and congenital CMV infection. (ClinicalTrials.gov number, NCT00125502.)