Gonçalves Caroline Amélia, Pereira-da-Silva Gabriela, Silveira Renata Cristina Campos Pereira, Mayer Paulo César Morales, Zilly Adriana, Lopes-Júnior Luís Carlos
Maternal-Infant and Public Health Nursing Department, University of São Paulo at Ribeirão Preto School of Nursing, Campus Ribeirão Preto, Ribeirão Preto 14040-902, Brazil.
Universidade CEUMA, São Luís 65075-120, Brazil.
Cancers (Basel). 2024 Feb 5;16(3):672. doi: 10.3390/cancers16030672.
Despite the knowledge that HPV is responsible for high-grade CIN and cervical cancer, little is known about the use of therapeutic vaccines as a treatment. We aimed to synthesize and critically evaluate the evidence from clinical trials on the safety, efficacy, and immunogenicity of therapeutic vaccines in the treatment of patients with high-grade CIN associated with HPV. A systematic review of clinical trials adhering to the PRISMA 2020 statement in MEDLINE/PubMed, Embase, CENTRAL Cochrane, Web of Science, Scopus, and LILACS was undertaken, with no data or language restrictions. Primary endpoints related to the safety, efficacy, and immunogenicity of these vaccines were assessed by reviewing the adverse/toxic effects associated with the therapeutic vaccine administration via histopathological regression of the lesion and/or regression of the lesion size and via viral clearance and through the immunological response of individuals who received treatment compared to those who did not or before and after receiving the vaccine, respectively. A total of 1184 studies were identified, and 16 met all the criteria. Overall, the therapeutic vaccines were heterogeneous regarding their formulation, dose, intervention protocol, and routes of administration, making a meta-analysis unfeasible. In most studies (n = 15), the vaccines were safe and well tolerated, with clinical efficacy regarding the lesions and histopathological regression or viral clearance. In addition, eleven studies showed favorable immunological responses against HPV, and seven studies showed a positive correlation between immunogenicity and the clinical response, indicating promising results that should be further investigated. In summary, therapeutic vaccines, although urgently needed to avoid progression of CIN 2/3 patients, still present sparse data, requiring greater investments in a well-designed phase III RCT.
尽管已知人乳头瘤病毒（HPV）是导致高级别宫颈上皮内瘤变（CIN）和宫颈癌的原因，但对于治疗性疫苗作为一种治疗手段的应用却知之甚少。我们旨在综合并批判性地评估关于治疗性疫苗治疗与HPV相关的高级别CIN患者的安全性、有效性和免疫原性的临床试验证据。我们对MEDLINE/PubMed、Embase、CENTRAL Cochrane、Web of Science、Scopus和LILACS中遵循PRISMA 2020声明的临床试验进行了系统评价，没有数据或语言限制。通过审查与治疗性疫苗给药相关的不良/毒性作用（通过病变的组织病理学消退和/或病变大小的消退、病毒清除）以及通过接受治疗的个体与未接受治疗的个体或接受疫苗前后个体的免疫反应，评估了这些疫苗与安全性、有效性和免疫原性相关的主要终点。共识别出1184项研究，其中16项符合所有标准。总体而言，治疗性疫苗在其制剂、剂量、干预方案和给药途径方面存在异质性，因此无法进行荟萃分析。在大多数研究（n = 15）中，疫苗是安全的且耐受性良好，对病变以及组织病理学消退或病毒清除具有临床疗效。此外，11项研究显示对HPV有良好的免疫反应，7项研究显示免疫原性与临床反应之间存在正相关，表明有值得进一步研究的有前景的结果。总之，治疗性疫苗虽然是避免CIN 2/3患者病情进展迫切需要的，但仍然缺乏数据，需要在精心设计的III期随机对照试验中投入更多资金。
Zotero 插件
