Noazin Sassan, Modabber Farrokh, Khamesipour Ali, Smith Peter G, Moulton Lawrence H, Nasseri Kiumarss, Sharifi Iraj, Khalil Eltahir A G, Bernal Ivan Dario Velez, Antunes Carlos M F, Kieny Marie Paule, Tanner Marcel
World Health Organization, CH1211, Geneva 27, Switzerland.
Vaccine. 2008 Dec 9;26(52):6759-67. doi: 10.1016/j.vaccine.2008.09.085. Epub 2008 Oct 23.
First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation. Although the studies demonstrated the safety of the vaccines and several studies showed reasonable immunogenicity and some indication of protection, an efficacious prophylactic vaccine is yet to be identified. Despite this overall failure, these trials contributed significantly to increasing knowledge on human leishmaniasis immunology. To provide a collective view, this review discusses the methods and findings of field efficacy trials of first generation leishmaniasis vaccine clinical trials conducted in the Old and New Worlds.
第一代抗利什曼病候选疫苗以灭活全寄生虫为主要成分制备，因其生产相对容易且成本低而被认为很有前景。几十年来，这些疫苗一直是众多研究的对象，并且是仅有的经过3期临床试验评估的利什曼病疫苗候选物。尽管研究证明了疫苗的安全性，一些研究显示出合理的免疫原性和一定的保护迹象，但尚未确定有效的预防性疫苗。尽管总体上失败了，但这些试验为增进对人类利什曼病免疫学的了解做出了重大贡献。为了提供一个全面的观点，本综述讨论了在新旧世界进行的第一代利什曼病疫苗临床试验的现场疗效试验的方法和结果。
