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首页> 外文期刊>Current opinion in HIV and AIDS >Overview of STEP and Phambili trial results: two phase IIb test-of-concept studies investigating the efficacy of MRK adenovirus type 5 gag/polef subtype B HIV vaccine.
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Overview of STEP and Phambili trial results: two phase IIb test-of-concept studies investigating the efficacy of MRK adenovirus type 5 gag/polef subtype B HIV vaccine.

机译：STEP和Phambili试验结果概述：两个IIb期概念测试研究，研究了5型MRK腺病毒gag / pol / nef B亚型HIV疫苗的功效。

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PURPOSE OF REVIEW: Two phase IIb test-of-concept studies evaluated the replication-defective adenovirus type 5 (Ad5) vaccine MRK gag/polef HIV vaccine to prevent infection or decrease early plasma viral load in disparate populations. The STEP study enrolled men and women in the Americas, Caribbean and Australia; the Phambili trial enrolled men and women in South Africa, where the modes of sexual transmission and HIV-1 risk, subtypes of HIV-1, and background Ad5 seroprevalence differed. RECENT FINDINGS: Vaccination in both studies were stopped, after the first interim efficacy analysis of the STEP study crossed predetermined nonefficacy boundaries. Neither trial demonstrated a decrease in HIV acquisition nor decreased early plasma viral load in vaccinees compared with placebo recipients. Post-hoc analyses of men enrolled in the STEP study showed a larger number of HIV infections in the subgroup of vaccinated men who were Ad5-seropositive and uncircumcised compared with a comparable placebo group. This was not demonstrated in the Phambili study, in which most men were heterosexual, whereas most in STEP were homosexual/bisexual. Further analysis of the STEP study has yet to explain the effect of Ad5 seroprevalence on increased HIV-1 susceptibility in men receiving the vaccine. However, promising vaccine effects on early viral control were seen, and the possibility of effects on early viral load set-point in women in Phambili was seen. SUMMARY: These trials have provided a number of lessons about the importance of clinical trials in the HIV vaccine discovery process, and insight into the type and level of immune response that will be required for control of viral replication.
机译：审查目的：两项IIb期概念测试研究评估了复制缺陷型5型腺病毒（Ad5）疫苗MRK gag / pol / nef HIV疫苗，以预防不同人群的感染或减少早期血浆病毒载量。 STEP的研究招收了美洲，加勒比和澳大利亚的男女。 Phambili试验在南非招募了男女，那里的性传播方式和HIV-1风险，HIV-1的亚型和背景Ad5血清阳性率有所不同。最近的发现：在STEP研究的第一个中期功效分析超过了预定的无效界限之后，两项研究均停止了疫苗接种。与安慰剂接受者相比，这两项试验均未显示疫苗接种者的艾滋病毒吸收减少或早期血浆病毒载量减少。对参加STEP研究的男性的事后分析显示，与可比的安慰剂组相比，在Ad5-血清阳性且未行包皮环切的已接种男性亚组中，HIV感染的数量更多。在Phambili研究中没有证明这一点，在该研究中，大多数男人是异性恋，而STEP中的大多数是同性恋/双性恋。 STEP研究的进一步分析尚未解释Ad5血清阳性率对接受疫苗的男性中HIV-1易感性增加的影响。但是，人们已经看到疫苗对早期病毒控制具有良好的作用，并且在法属比利妇女中也看到了对早期病毒载量设定值产生影响的可能性。简介：这些试验提供了许多教训，说明了临床试验在HIV疫苗发现过程中的重要性，并深入了解了控制病毒复制所需的免疫应答的类型和水平。

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