Raccagni Angelo Roberto, Diotallevi Sara, Lolatto Riccardo, Lucente Maria Francesca, Candela Caterina, Gianotti Nicola, Trentacapilli Benedetta, Canetti Diana, Castagna Antonella, Nozza Silvia
Vita-Salute San Raffaele University.
Infectious Diseases Unit, San Raffaele Scientific Institute, Milan, Italy.
AIDS. 2023 Dec 1;37(15):2365-2369. doi: 10.1097/QAD.0000000000003733. Epub 2023 Sep 28.
The study aim was to evaluate whether mpox vaccination with modified vaccinia Ankara-Bavarian Nordic (MVA-BN) may be associated with viral blips or confirmed virologic failures (CVF) in people with HIV (PWH) receiving antiretroviral therapy and the associated factors.
PWH who received MVA-BN, with HIV-RNA less than 50 copies/ml, and CD4 + lymphocytes at least 200 cells/μl in the 6 months prior to vaccination and at least 1 HIV-RNA determination within 3 months from vaccination.
The primary outcome was occurrence of viral blips (1 HIV-RNA ≥50 copies/ml) and CVF (1 HIV-RNA ≥1000 copies/ml or ≥2 consecutive HIV-RNA ≥50 copies/ml) following MVA-BN. Changes in CD4 + and CD4 + /CD8 + were secondary outcomes. Residual viremia was defined as detectable HIV-RNA less than 50 copies/ml. PWH already vaccinated against smallpox received single-dose MVA-BN. Mann--Whitney rank-sum test or chi-square/Fisher's test applied.
Overall, 187 PWH were included: 147 received two doses of MVA-BN, 40 single-dose. Six viral blips [incidence rate = 1.59/100-person months of follow-up (PMFU), 95% confidence interval (95% CI) = 0.58-3.47], and three CVFs [incidence rate = 0.80/100-PMFU (95% CI = 0.16-2.33)] were observed. Two CVFs occurred at second dose with presence of detectable HIV-RNA following first one, with high compliance to antiretroviral therapy (ART). PWH with viral blips or CVFs had, prior to first vaccination, more frequently residual viremia [77% ( n = 7) versus 35% ( n = 62), P = 0.01]. No differences in ART ( P = 0.42) and number of MBA-BN doses ( P = 0.40) was found. In two cases of CVFs, ART was changed; all VBs resolved within 1 month.
Although rare, viral blips and CVFs following MVA-BN vaccination among PWH receiving ART were identified. Close monitoring of HIV-RNA during mpox vaccination should be encouraged.
本研究旨在评估接种改良安卡拉痘苗-巴伐利亚北欧株（MVA-BN）进行猴痘疫苗接种是否可能与接受抗逆转录病毒治疗的艾滋病毒感染者（PWH）出现病毒波动或确诊病毒学失败（CVF）及其相关因素有关。
接种MVA-BN的PWH，接种前6个月HIV-RNA低于50拷贝/ml，CD4+淋巴细胞至少200个/μl，且接种后3个月内至少进行1次HIV-RNA检测。
主要结局是接种MVA-BN后出现病毒波动（1次HIV-RNA≥50拷贝/ml）和CVF（1次HIV-RNA≥1000拷贝/ml或≥2次连续HIV-RNA≥50拷贝/ml）。CD4+和CD4+/CD8+的变化为次要结局。残余病毒血症定义为可检测到的HIV-RNA低于50拷贝/ml。已接种天花疫苗的PWH接种单剂量MVA-BN。采用曼-惠特尼秩和检验或卡方/费舍尔检验。
总体而言，纳入了187名PWH：147人接种两剂MVA-BN，40人接种单剂量。观察到6次病毒波动[发病率=1.59/100人月随访（PMFU），95%置信区间（95%CI）=0.58-3.47]，以及3次CVF[发病率=0.80/100-PMFU（95%CI=0.16-2.33）]。2次CVF发生在第二剂接种后，第一剂接种后存在可检测到的HIV-RNA，对抗逆转录病毒治疗（ART）的依从性高。出现病毒波动或CVF的PWH在首次接种前更频繁地出现残余病毒血症[77%（n=7）对35%（n=62），P=0.01]。在ART（P=0.42）和MVA-BN剂量数（P=0.40）方面未发现差异。在2例CVF病例中，更改了ART；所有病毒波动在1个月内消退。
尽管罕见，但在接受ART的PWH中，接种MVA-BN后出现了病毒波动和CVF。应鼓励在猴痘疫苗接种期间密切监测HIV-RNA。
