A Novel Tetravalent Dengue Vaccine Is Well Tolerated and Immunogenic against All 4 Serotypes in Flavivirus-Naive Adults
A Novel Tetravalent Dengue Vaccine Is Well Tolerated and Immunogenic against All 4 Serotypes in Flavivirus-Naive Adults
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DOI：
10.1086/649916
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发表时间：
2010-02-01
影响因子：
6.4
通讯作者：
Lang, Jean
中科院分区：
文献类型：
--
作者：
Morrison, Dennis;Legg, Thomas J.;Lang, Jean
背景资料。赛诺菲巴斯德已经开发出一种针对世界上最常见的虫媒病毒感染的四价登革疫苗(TDV)。我们评估了TDV在健康成人中的安全性和免疫原性，随机分为两组。组1在0、4和12-15个月接受3次TDV注射；组2在0个月接受生理盐水安慰剂治疗，然后在4个月和12-15个月注射2次TDV。记录不良事件，测量生物学参数和病毒血症水平。免疫前后分别检测4株世界卫生组织(WHO)参考毒株的中和抗体。每组共有33名参与者。人口统计特征具有可比性。没有疫苗相关的严重不良事件报告。最常见的全身反应是头痛、不适和肌肉痛。检测到低水平的病毒血症，主要是血清4型。免疫应答随着疫苗剂量的增加而增加。所有参与者在0、4和12-15个月接种3剂疫苗后，对所有4种血清型的血清转换，几乎所有参与者在间隔8-11个月接种2剂疫苗后血清转换。赛诺菲·巴斯德的TDV耐受性良好，并在3次接种后诱导对所有世卫组织参考菌株血清型的完全血清转换。
Background. Sanofi Pasteur has developed a tetravalent dengue vaccine (TDV) against the world's most common arbovirus infection.Methods. We assessed the safety and immunogenicity of the TDV in healthy adults randomized into 2 groups. Group 1 received 3 TDV injections at months 0, 4, and 12-15; group 2 received saline placebo at month 0 and then 2 TDV injections at months 4 and 12-15. Adverse events were recorded, and biological parameters and viremia levels were measured. Neutralizing antibodies against 4 World Health Organization (WHO) reference strains were measured before and after vaccinations.Results. A total of 33 participants were enrolled in each group. Demographic characteristics were comparable. No vaccine-related serious adverse event was reported. The most common systemic reactions were headache, malaise, and myalgia. Low viremia levels were detected, mainly of serotype 4. Immune response increased with successive vaccine doses. All participants seroconverted against all 4 serotypes after receiving 3 doses at 0, 4, and 12-15-months, and almost all seroconverted after 2 doses given 8-11 months apart.Conclusions. Sanofi Pasteur's TDV was well tolerated and induced full seroconversion against all WHO reference strain serotypes after 3 doses.