Center for Evidence and Health Technology Assessment (NETecS), Universidade de Brasília (UnB), Campus UnB Ceilândia, Centro Metropolitano, Ceilândia Sul, CEP: 72220-275, Brasília/DF, Brazil.
Health Technology Assessment Unit, MBA in Health Technology Assessment, Oswaldo Cruz German Hospital (HAOC), São Paulo, Brazil.
BMC Infect Dis. 2023 Aug 29;23(1):563. doi: 10.1186/s12879-023-08541-0.
Influenza infection is a highly preventable transmissible viral disease associated with mild upper respiratory symptoms and more severe conditions such as lethal pneumonia. Studies have shown that a broader spectrum influenza vaccine could reduce influenza's burden of disease in low- and middle-income countries. A considerable number of systematic reviews reported that quadrivalent influenza vaccines are considered more effective compared to trivalent vaccines, hence, there is a need for an overview in order to synthesize the current evidence pertaining to the comparison between quadrivalent and trivalent inactivated influenza vaccines.
The aim was to summarize the evidence from systematic reviews that investigated the immunogenicity and safety of the Influenza's inactivated quadrivalent vaccine (QIV) compared to the trivalent vaccine (TIV), in the general population.
We searched articles up to December 2022 at: Web of Science, EMBASE, MEDLINE, Cochrane Library, and SCOPUS. The search strategy was conducted following the PICO model. We included systematic reviews comparing the primary outcomes of immunogenicity (seroprotection rate and seroconversion rate) and adverse events using risk ratios. The AMSTAR 2 and ROBIS were used for quality assessments, and GRADE was used for evidence certainty assessments.
We included five systematic reviews, totalling 47,740 participants. The Quadrivalent Inactivated Influenza Vaccine (QIV) exhibited enhanced immunogenicity in the context of B-lineage mismatch when compared to the Trivalent Inactivated Influenza Vaccine (TIV). While the safety profile of QIV was found to be comparable to that of TIV, the QIV showed a higher incidence of solicited local pain among children and adolescents, as well as an increased frequency of local adverse events within the adult population.
Our findings suggest that the QIV provides a superior immunogenicity response compared to the TIV in all age groups evaluated, especially when a lineage mismatch occurred. The safety of QIV was considered similar to the TIV, with no serious or systemic solicited or unsolicited adverse events; tough pain at the injection site was greater for QIV. We recommend caution owing to the high risk of bias in the selection process and no protocol registration.
流感感染是一种高度可预防的传染性病毒疾病，可引起轻度上呼吸道症状和更严重的疾病，如致命性肺炎。研究表明，广谱流感疫苗可降低中低收入国家流感的疾病负担。大量系统评价报告称，四价流感疫苗比三价疫苗更有效，因此，有必要进行综述以综合当前关于四价和三价流感灭活疫苗比较的证据。
总结系统评价的证据，调查在一般人群中，流感灭活四价疫苗（QIV）与三价疫苗（TIV）的免疫原性和安全性。
我们在以下数据库中搜索截至 2022 年 12 月的文章：Web of Science、EMBASE、MEDLINE、Cochrane 图书馆和 SCOPUS。搜索策略遵循 PICO 模型。我们纳入了比较免疫原性（血清保护率和血清转化率）和使用风险比的不良事件的主要结局的系统评价。使用 AMSTAR 2 和 ROBIS 进行质量评估，使用 GRADE 进行证据确定性评估。
我们纳入了五项系统评价，共纳入 47740 名参与者。与三价流感灭活疫苗（TIV）相比，四价流感灭活疫苗（QIV）在 B 谱系错配时表现出增强的免疫原性。虽然 QIV 的安全性与 TIV 相当，但 QIV 在儿童和青少年中更易发生局部疼痛，在成年人群中更易发生局部不良事件。
我们的研究结果表明，在评估的所有年龄组中，QIV 与 TIV 相比提供了更好的免疫原性反应，尤其是在发生谱系错配时。QIV 的安全性被认为与 TIV 相似，没有严重或全身性的局部或全身不良事件；尽管 QIV 的注射部位疼痛更大。由于选择过程的高偏倚风险和没有方案注册，我们建议谨慎使用。
