Recombinant gp350 vaccine for infectious mononucleosis: A phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults
Recombinant gp350 vaccine for infectious mononucleosis: A phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults
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DOI：
10.1086/523813
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发表时间：
2007-12-15
影响因子：
6.4
通讯作者：
Denis, Martine
中科院分区：
文献类型：
--
作者：
Sokal, Etienne M.;Hoppenbrouwers, Karel;Denis, Martine
背景。迄今为止，还没有商业上可用的疫苗来预防传染性单核细胞增多症，这种疾病通常由缺乏病毒免疫力的青少年或成人感染 Epstein-Barr 病毒 (EBV) 引起。总共 181 名 EBV 血清阴性、健康、年轻的成年志愿者以双盲方式随机接受安慰剂或重组 EBV 亚基糖蛋白 350 (gp350)/氢氧化铝和 3-O-去酰基-4'-单磷酰脂质 A (AS04) 候选疫苗的 3 剂量方案。结果。该疫苗在预防EBV感染引起的传染性单核细胞增多症方面具有明显的功效（平均有效率78.0％[95％置信区间{CI}，1.0％-96.0％]），但对预防无症状EBV感染没有功效。接受最后一剂 gp350 疫苗一个月后，98.7% 的受试者表现出抗 gp350 抗体的血清转化（95% CI，85.5%-97.9%），并且他们保持抗 gp350 抗体阳性超过 18 个月。此外，没有人担心 gp350/AS04 疫苗的安全性或反应原性。结论。这些数据支持使用 EBV 疫苗预防传染性单核细胞增多症的临床可行性。
Background. To date, there is no commercially available vaccine to prevent infectious mononucleosis, a disease frequently induced by Epstein-Barr virus (EBV) infection in adolescents or adults devoid of preexisting immunity to the virus.Methods. A total of 181 EBV-seronegative, healthy, young adult volunteers were randomized in a double-blind fashion to receive either placebo or a recombinant EBV subunit glycoprotein 350 (gp350)/aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A (AS04) candidate vaccine in a 3-dose regimen.Results. The vaccine had demonstrable efficacy (mean efficacy rate, 78.0% [95% confidence interval {CI}, 1.0% -96.0%]) in preventing the development of infectious mononucleosis induced by EBV infection, but it had no efficacy in preventing asymptomatic EBV infection. One month after receipt of the final dose of gp350 vaccine, 98.7% of subjects showed seroconversion to anti-gp350 antibodies (95% CI, 85.5%-97.9%), and they remained anti-gp350 antibody positive for > 18 months. Furthermore, there were no concerns regarding the safety or reactogenicity of the gp350/AS04 vaccine.Conclusion. These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis.