Pileggi Claudia, Lotito Francesca, Bianco Aida, Nobile Carmelo G A, Pavia Maria
Department of Health Sciences, University of Catanzaro "Magna Græcia", Via Tommaso Campanella, 88100, Catanzaro, Italy.
BMC Infect Dis. 2015 Oct 14;15:427. doi: 10.1186/s12879-015-1161-z.
The primary influenza prevention strategy is focused on annual vaccination according to the categories identified in the various countries as being at greatest risk of complications. Many studies were conducted in order to demonstrate that intradermal (ID) vaccine formulation represents a promising alternative to conventional intramuscular (IM) formulation, especially in subjects with an impaired immune system. However, there is no consensus whether the efficacy and safety of ID is equivalent to IM in these subjects. Therefore, we performed a meta-analysis of Randomized Controlled Trials (RCT) to compare the immunogenicity and safety of ID and IM influenza vaccines in subjects with a depleted immune system.
We conducted a search strategy of medical literature published until November 2014 in order to identify RCTs that evaluated the immunogenicity and safety of ID compared with IM influenza vaccines in immunocompromized patients.
We identified a total of 269 citations through research in electronic databases and scanning reference lists. Of these, 6 articles were included in the meta-analysis, for a total of 673 subjects. The seroprotection rate induced by the ID vaccine is comparable to that elicited by the IM vaccine. The overall RR was 1.00 (95 % CI = 0.91 -1.10) for A/H1N1 strain, 1.00 (95 % CI = 0.90-1.12) for A/H3N2 and 0.99 (95 % CI = 0.84 -1.16) for B strain. No significant differences in the occurrence of systemic reactions were detected (17.7 % in the ID group vs 18.2 % in the IM group) with a pooled RR = 1.00 (95 % CI = 0.67 -1.51), whereas ID administration caused significantly more injection site reactions with a mean frequency of 46 % in the ID group compared to 22 % in the IM group, with a pooled RR = 1.89 (95 % CI = 1.40 -2.57).
The ID influenza vaccine has shown a similar immunogenicity and safety to the IM influenza vaccine in immunocompromized patients, and it may be a valid option to increase compliance to influenza vaccination in these populations.
主要的流感预防策略集中在根据各国确定的并发症风险最高的类别进行年度疫苗接种。为了证明皮内（ID）疫苗制剂是传统肌肉注射（IM）制剂的一种有前景的替代方法，尤其是在免疫系统受损的受试者中，人们进行了许多研究。然而，在这些受试者中，ID疫苗的有效性和安全性是否等同于IM疫苗，尚无共识。因此，我们进行了一项随机对照试验（RCT）的荟萃分析，以比较ID和IM流感疫苗在免疫系统耗竭的受试者中的免疫原性和安全性。
我们对截至2014年11月发表的医学文献进行了检索，以确定评估ID与IM流感疫苗在免疫功能低下患者中的免疫原性和安全性的RCT。
通过电子数据库检索和扫描参考文献列表，我们共识别出269条引用。其中，6篇文章被纳入荟萃分析，共有673名受试者。ID疫苗诱导的血清保护率与IM疫苗诱导的血清保护率相当。对于A/H1N1毒株，总体相对危险度（RR）为1.00（95%置信区间[CI]=0.91-1.10）；对于A/H3N2毒株，为1.00（95%CI=0.90-1.12）；对于B毒株，为0.99（95%CI=0.84-1.16）。未检测到全身反应发生率的显著差异（ID组为17.7%，IM组为18.2%），合并RR=1.00（95%CI=0.67-1.51），而ID接种引起的注射部位反应明显更多，ID组的平均发生率为46%，而IM组为22%，合并RR=1.89（95%CI=1.40-2.57）。
ID流感疫苗在免疫功能低下的患者中显示出与IM流感疫苗相似的免疫原性和安全性，它可能是提高这些人群流感疫苗接种依从性的一个有效选择。
