Barrett Alan D T
Sealy Institute for Vaccine Sciences and Department of Pathology, University of Texas Medical Branch, Galveston, TX 77555-0436 USA.
NPJ Vaccines. 2018 Jun 11;3:24. doi: 10.1038/s41541-018-0061-9. eCollection 2018.
Zika virus (ZIKV), a mosquito-borne flavivirus, was first identified in the 1940s in Uganda in Africa and emerged in the Americas in Brazil in May 2015. In the 30 months since ZIKV emerged as a major public health problem, spectacular progress has been made with vaccine development cumulating with the publication of three reports of phase 1 clinical trials in the 4th quarter of 2017. Clinical trials involving candidate DNA and purified inactivated virus vaccines showed all were safe and well-tolerated in the small number of volunteers and all induced neutralizing antibodies, although these varied by vaccine candidate and dosing regimen. These results suggest that a Zika vaccine can be developed and that phase 2 clinical trials are warranted. However, it is difficult to compare the results from the different phase 1 studies or with neutralizing antibodies induced by licensed flavivirus vaccines (Japanese encephalitis, tick-borne encephalitis, and yellow fever) as neutralizing antibody assays vary and, unfortunately, there are no standards for Zika virus neutralizing antibodies. In addition to clinical studies, substantial progress continues to be made in nonclinical development, particularly in terms of the ability of candidate vaccines to protect reproductive tissues, and the potential use of monoclonal antibodies for passive prophylaxis.
寨卡病毒(ZIKV)是一种通过蚊子传播的黄病毒,于20世纪40年代在非洲的乌干达首次被发现,并于2015年5月在巴西出现在美洲。自寨卡病毒成为一个主要的公共卫生问题以来的30个月里,疫苗研发取得了显著进展,2017年第四季度发表了三份1期临床试验报告。涉及候选DNA疫苗和纯化灭活病毒疫苗的临床试验表明,在少数志愿者中,所有疫苗都是安全且耐受性良好的,并且都诱导产生了中和抗体,尽管这些抗体因候选疫苗和给药方案而异。这些结果表明可以开发出寨卡疫苗,并且有必要进行2期临床试验。然而,由于中和抗体检测方法各不相同,而且不幸的是,对于寨卡病毒中和抗体没有标准,因此很难比较不同1期研究的结果,也很难与已获许可的黄病毒疫苗(日本脑炎、蜱传脑炎和黄热病)诱导产生的中和抗体进行比较。除了临床研究之外,非临床研发也在继续取得重大进展,特别是在候选疫苗保护生殖组织的能力以及单克隆抗体用于被动预防的潜在用途方面。