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首页> 外文期刊>Vaccine >Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity
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Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity

机译：基于修饰的牛痘病毒安卡拉（MVA）有或没有DNA引发的预防性HIV-1疫苗候选者的研究：剂量和途径对安全性和免疫原性的影响

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BACKGROUND: Two parallel studies evaluated safety and immunogenicity of a prophylactic HIV-1 vaccine in 192 HIV-seronegative, low-risk volunteers. Modified vaccinia virus Ankara (MVA) and plasmid DNA (pTHr) expressed HIV-1 clade A gag p24 and p17 fused to a string of 25 overlapping CD8+ T cell epitopes (HIVA). METHODS: These studies compared intramuscular, subcutaneous, and intradermal MVA at dosage levels ranging from 5x10(6)-2.5x10(8) pfu. In Study IAVI-010, DNA vaccine was given as a prime at months 0 and 1, followed by MVA as a boost at months 5 and 8. In Study IAVI-011, MVA alone was given at months 0 and 2. Regular safety monitoring was performed. Immunogenicity was measured by the interferon (IFN)-gamma ELISPOT assay on peripheral blood mononuclear cells (PBMC). RESULTS: No serious adverse events were attributed to either vaccine; most adverse events were mild or moderate, although MVA resulted in some severe local reactions. Five vaccine recipients had at least one positive IFN-gamma ELISPOT response, but none were sustained. CONCLUSION: This HIV-1 vaccine candidate was in general safe and well-tolerated. Local reactions were common, but tolerable. Detectable immune responses were infrequent.
机译：背景：两项平行研究评估了192名HIV阴性，低风险志愿者中预防性HIV-1疫苗的安全性和免疫原性。修饰的牛痘病毒安卡拉（MVA）和质粒DNA（pTHr）表达了HIV-1进化枝A gag p24和p17，融合了25个重叠的CD8 + T细胞表位（HIVA）。方法：这些研究比较了肌肉内，皮下和皮内MVA的剂量水平为5x10（6）-2.5x10（8）pfu。在研究IAVI-010中，在第0和1个月给予DNA疫苗初次接种，然后在第5和8个月给予MVA加强免疫。在研究IAVI-011中，在第0和2个月单独给予MVA。被执行了。通过外周血单个核细胞（PBMC）的干扰素（IFN）-γELISPOT测定法测量免疫原性。结果：两种疫苗均未引起严重不良事件。尽管MVA会引起一些严重的局部反应，但大多数不良事件是轻度或中度。五名疫苗接种者至少具有一种阳性的IFN-γELISPOT阳性反应，但没有持续。结论：该候选HIV-1疫苗总体上安全且耐受性良好。局部反应很普遍，但可以忍受。可检测的免疫反应很少。

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