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首页> 美国卫生研究院文献>BMJ Open >Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial
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Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial

机译：单独评估抗HIV单克隆抗体CAP256V2LS的安全性和药代动力学并与南非妇女的VRC07-523LS和PGT121组合：第一载于人类Caprisa 012B期I12B期临床试验的研究方案

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摘要

New HIV prevention strategies are urgently required. The discovery of broadly neutralising antibodies (bNAbs) has provided the opportunity to evaluate passive immunisation as a potential prevention strategy and facilitate vaccine development. Since 2014, several bNAbs have been isolated from a clade C-infected South African donor, CAPRISA 256. One particular bNAb, CAP256-VRC26.25, was found to be extremely potent, with good coverage against clade C viruses, the dominant HIV clade in sub-Saharan Africa. Challenge studies in non-human primates demonstrated that this antibody was fully protective even at extremely low doses. This bNAb was subsequently structurally engineered and the clinical variant is now referred to as CAP256V2LS.
机译：迫切需要新的艾滋病毒预防策略。广泛中和抗体（BNABs）的发现提供了评估被动免疫作为潜在预防策略并促进疫苗发育的机会。自2014年以来，几个BNAB已经从C感染的南非捐赠者，Caprisa 256中分离出来。一个特定的BNAB，第256-VRC26.25被认为是极其有效的，具有良好的覆盖患者，占据C型病毒，优势艾滋病毒在撒哈拉以南非洲。非人类原始动物的挑战性研究表明，即使在极低的剂量下也是完全保护性的。随后将该BNAB结构化工程化，临床变体现在被称为CAP256V2LS。

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