Zizza Antonella, Banchelli Federico, Guido Marcello, Marotta Claudia, Di Gennaro Francesco, Mazzucco Walter, Pistotti Vanna, D'Amico Roberto
Institute of Clinical Physiology, National Research Council, 73100, Lecce, Italy.
Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, 41100, Modena, Italy.
Sci Rep. 2021 Mar 2;11(1):4954. doi: 10.1038/s41598-021-83727-7.
The prophylactic vaccines available to protect against infections by HPV are well tolerated and highly immunogenic. People with HIV have a higher risk of developing HPV infection and HPV-associated cancers due to a lower immune response, and due to viral interactions. We performed a systematic review of RCTs to assess HPV vaccines efficacy and safety on HIV-infected people compared to placebo or no intervention in terms of seroconversion, infections, neoplasms, adverse events, CD4+ T-cell count and HIV viral load. The vaccine-group showed a seroconversion rate close to 100% for each vaccine and a significantly higher level of antibodies against HPV vaccine types, as compared to the placebo group (MD = 4333.3, 95% CI 2701.4; 5965.1 GMT EL.U./ml for HPV type 16 and MD = 1408.8, 95% CI 414.8; 2394.7 GMT EL.U./ml for HPV type 18). There were also no differences in terms of severe adverse events (RR = 0.6, 95% CI 0.2; 1.6) and no severe adverse events (RR = 0.6, 95% CI 0.9; 1.2) between vaccine and placebo groups. Secondary outcomes, such as CD4 + T-cell count and HIV viral load, did not differ between groups (MD = 14.8, 95% CI - 35.1; 64.6 cells/µl and MD = 0.0, 95% CI - 0.3; 0.3 log10 RNA copies/ml, respectively). Information on the remaining outcomes was scarce and that did not allow us to combine the data. The results support the use of the HPV vaccine in HIV-infected patients and highlight the need of further RCTs assessing the effectiveness of the HPV vaccine on infections and neoplasms.
现有的预防人乳头瘤病毒(HPV)感染的预防性疫苗耐受性良好且免疫原性高。由于免疫反应较低以及病毒相互作用,艾滋病毒感染者感染HPV及患HPV相关癌症的风险更高。我们对随机对照试验(RCT)进行了系统评价,以评估与安慰剂或无干预措施相比,HPV疫苗在艾滋病毒感染者中的血清转化、感染、肿瘤、不良事件、CD4 + T细胞计数和艾滋病毒病毒载量方面的疗效和安全性。与安慰剂组相比,疫苗组每种疫苗的血清转化率接近100%,且针对HPV疫苗型别的抗体水平显著更高(16型HPV的平均差异(MD)=4333.3,95%置信区间(CI)2701.4;5965.1 GMT EL.U./ml,18型HPV的MD =1408.8,95% CI 414.8;2394.7 GMT EL.U./ml)。疫苗组和安慰剂组在严重不良事件(风险比(RR)=0.6,95% CI 0.2;1.6)和无严重不良事件(RR =0.6,95% CI 0.9;1.2)方面也无差异。次要结局,如CD4 + T细胞计数和艾滋病毒病毒载量,在两组之间无差异(MD分别为14.8,95% CI - 35.1;64.6个细胞/微升和MD =0.0,95% CI - 0.3;0.3 log10 RNA拷贝/毫升)。关于其余结局的信息较少,因此我们无法合并数据。结果支持在艾滋病毒感染患者中使用HPV疫苗,并强调需要进一步开展随机对照试验来评估HPV疫苗对感染和肿瘤的有效性。