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在未感染HIV疫苗接种者中,疫苗诱导的HIV血清阳性/活性

Cristine J Cooper¹, Barbara Metch, Joan Dragavon

¹Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

|July 20, 2010

概括

疫苗诱导的血清阳性/反应性 (VISP) 在艾滋病毒疫苗试验参与者中很常见,影响了41.7%的受试者. 根据疫苗类型和检测方法,VISP的发病率有所不同,这凸显了对接种疫苗的人群HIV检测结果的仔细解释的必要性.

科学领域:

免疫学免疫学免疫学
疫苗学疫苗学疫苗学
临床试验临床试验

背景情况:

开发一种抗人类免疫缺陷病毒 (HIV) 的保护性疫苗至关重要.
艾滋病毒疫苗可能导致常规艾滋病毒检测对未感染个人的错误阳性结果.

研究的目的:

为了确定艾滋病毒疫苗试验参与者的疫苗诱导血清阳性/反应 (VISP) 的频率.
分析影响VISP发生的因素,包括疫苗类型和诊断试验.

主要方法:

使用三个FDA批准的酶免疫测试 (EIA) 艾滋病毒抗体套件评估VISP.
从1期和2a期疫苗试验 (2000-2010年) 中,对艾滋病病毒阴性成年人进行了VISP频率评估.
通过核酸检测,VISP被定义为对EIA有反应性,西方斑阴性或非典型阳性,以及HIV-1-阴性.

主要成果:

41.7% (908/2176) 的未感染艾滋病毒的参与者患有VISP.
根据疫苗产品,VISP的发病率有显著差异:腺病毒5的86.7%,小鼠病毒的53.4%,单独DNA疫苗的6.3%.
艾滋病毒1/2 (rDNA) EIA套件显示VISP比例最高 (40.9%),而10.2%的VISP病例具有异常模式的阳性西部斑.

结论:

在HIV疫苗接种者中,VISP是常见的,特别是在编码HIV-1包裹和核心抗原的疫苗中.
疫苗的免疫性和使用的特定EIA测定与VISP的开发和检测有关.

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