PBMC Gene expression of participants in the kick and kill clinical trial BCN02

The BCN02 (NCT02616874) was a pilot study to evaluate the kick and kill therapy on 15 early-treated individuals that were rolled-over from the BCN01 Study. The participants in the study received two MVA.HIVconsv vaccination before and after the 3-cycle infusion of Romidepsin, an inhibitor of histone deacetylases that act as a latency reversing agent. Additionally, the inclusion of a monitored antiretroviral pause (MAP) allowed tthe identification of 8 individuals with an Early Rebound (pVL > 2,000 HIV RNA copies/mL, < 4 weeks of MAP initiation) and 4, with a Late Rebound (pVL > 2,000 HIV RNA copies/mL, > 4 weeks of MAP initiation). In the present study we studied gene expression at 3 different timepoints: w0 (Bsl), w1 (Vacc), w6 (Vacc+RMD) and applied pairwise comparisons. Overall design: PBMCs from the 15 individuals enrolled in BCN02 clinical trial were taken at 5 different timepoints: w0, w1, w6, MAP and w24.

BCN02（临床试验注册号NCT02616874）是一项先导性研究，旨在评估“激活并清除”（kick and kill）疗法对15名从BCN01研究转组的早期治疗受试者的应用效果。本研究的受试者在3周期罗米地辛（Romidepsin，组蛋白去乙酰化酶抑制剂，作为潜伏期逆转剂）输注前后，先后接受两次MVA.HIVconsv疫苗接种。此外，通过设置监测性抗逆转录病毒暂停（monitored antiretroviral pause, MAP）方案，共筛选出8名早期反弹者（血浆病毒载量pVL＞2000 HIV RNA拷贝/mL，且MAP启动后＜4周）以及4名晚期反弹者（pVL＞2000 HIV RNA拷贝/mL，且MAP启动后＞4周）。本研究在w0（基线Bsl）、w1（疫苗接种Vacc）、w6（疫苗联合罗米地辛Vacc+RMD）这3个不同时间点开展基因表达分析，并实施两两比较。整体实验设计：纳入BCN02临床试验的15名受试者的外周血单个核细胞（PBMCs），分别在w0、w1、w6、MAP启动时以及w24共5个时间点采集。