HIV预防性疫苗Ⅱ/Ⅲ期临床试验研究系统综述

A systematic review of phase Ⅱ/Ⅲ trials of preventive HIV vaccine

本文旨在通过对全球HIV预防性疫苗Ⅱ/Ⅲ期临床试验的系统综述,指导我国的HIV预防性疫苗临床试验研究。使用医学主题词表(medical subject headings,Mesh)词和自由词共同检索的方式收集Medline上收录的国内外关于HIV预防性疫苗Ⅱ/Ⅲ期临床试验研究,汇总及分析各临床试验疫苗类型、临床试验对象、疫苗免疫原性及有效性等方面信息。按照纳入排除标准进行筛选,一共纳入25个HIV预防性疫苗Ⅱ/Ⅲ期临床试验研究。汇总分析显示,HIV预防性疫苗类型呈现多样化发展,由于HIV高度变异,机体对其免疫保护机制尚未明确以及体内预先免疫对于载体介导疫苗得到效果干扰,候选疫苗有待进一步研究探索;根据既往经验,未来在我国开展大型临床试验研究,需要针对我国流行亚型采用多重疫苗类型组合,并且前期要对于高危人群的发病率、随访率及其意愿性进行调查确认。

This systematic review aims to provide with information for the future clinical trials of human immunode- ficiency virus （HIV） preventive vaccine in China on the phase Ⅱ/Ⅲ clinical trials of HIV preventive vaccines worldwide. Related literatures were collected by the joint use of medical subject headings （Mesh） and free terms from Medline. The types of vaccination, research subjects, immunogenicity and the efficacy of the clinical trials were sorted out and analyzed. According to the inclusive and exclusive criteria, total twenty five literatures were selected. There were more and more vari- ous types and the strategies of the vaccination with stronger immunogenieity, yet RV144 was the only clinical trial with sig- nificant efficacy. Based on the previous worldwide researches＇ findings, while many types of HIV preventive vaccines have been developed, there is still the need to explore potential candidates for HIV has various mutation, and there are confu- sions about protective immune response to HIV and pre-immnne response to viral vectors effecting the vaccine efficacy. Ac- cording to the previous experiences, it is necessary to target the local epidemic HIV genotypes, to apply the regimens of multiple vaccines and to investigate the HIV incidence rate, follow-up rate and willing-to-participate rate of high-risk popu- lations in advance if large clinical trials of HIV preventive vaccines will be conducted in China.