Chan Tuen-Ching, Hung Ivan Fan-Ngai, Chan Kwok-Hung, Li Clara Pui-Yan, Li Patrick Tsz-Wai, Luk James Ka-Hay, Chu Leung-Wing, Chan Felix Hon-Wai
Department of Medicine and Geriatrics, TWGHs Fung Yiu King Hospital, Hong Kong SAR, China; Division of Geriatrics, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
Division of Infectious Disease, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
J Am Med Dir Assoc. 2014 Aug;15(8):607.e5-12. doi: 10.1016/j.jamda.2014.05.002. Epub 2014 Jun 21.
To compare the immunogenicity and safety between full-dose (15 μg) intramuscular (i.m.) and full-dose (15 μg) intradermal (i.d.) immunization of the trivalent influenza vaccine in nursing home older adults.
A single-center, randomized, controlled, open-label, parallel group trial from October 2013 to April 2014.
Nine nursing homes in Hong Kong.
Hundred nursing home older adults (mean age: 82.9 ± 7.4 years).
Fifty received i.d. (Intanza) and 50 received i.m. (Vaxigrip) vaccination.
Baseline measurements included demographics, comorbidity, frailty and nutritional status. Day 21 and day 180 immunogenicity (seroconversion rate, seroprotection rate, geometric mean titer [GMT] fold increase in antibody titer) using hemagglutination-inhibition and adverse events were measured. Noninferiority and superiority of i.d. compared with i.m. vaccination in immunogenicity were analyzed. The study was registered on ClinicalTrials.gov; identifier: NCT 01967368.
At day 21, noninferiority in immunogenicity of the i.d. vaccination was demonstrated. The seroconversion rate of the H1N1 strain was significantly higher in the i.d. group. At day 180, immunogenicity of both groups fell but the GMT of all strains in i.d. group was higher and the difference was significant for H3N2 strain. The seroconversion rate and GMT fold increase of H3N2 strain was significantly higher in the i.d. group. Local adverse events was significantly more in i.d. group, but they were mild and resolved in 72 hours.
I.d. vaccination is noninferior, and even superior in some parts of immunogenicity assessment, to i.m. vaccination without compromising safety in nursing home older adults. I.d. vaccination is a good alternative to i.m. vaccination in this population.
比较全剂量（15μg）三价流感疫苗肌内注射和皮内注射在养老院老年人中的免疫原性和安全性。
2013年10月至2014年4月进行的单中心、随机、对照、开放标签、平行组试验。
香港的九家养老院。
100名养老院老年人（平均年龄：82.9±7.4岁）。
50人接受皮内注射（Intanza），50人接受肌内注射（Vaxigrip）疫苗接种。
基线测量包括人口统计学、合并症、虚弱和营养状况。使用血凝抑制法测量第21天和第180天的免疫原性（血清转化率、血清保护率、抗体滴度几何平均滴度[GMT]倍数增加）以及不良事件。分析皮内注射与肌内注射在免疫原性方面的非劣效性和优越性。该研究已在ClinicalTrials.gov上注册；标识符：NCT 01967368。
在第21天，证明了皮内注射疫苗在免疫原性方面的非劣效性。皮内注射组中H1N1毒株的血清转化率显著更高。在第180天，两组的免疫原性均下降，但皮内注射组所有毒株的GMT更高，且H3N2毒株的差异显著。皮内注射组中H3N2毒株的血清转化率和GMT倍数增加显著更高。皮内注射组的局部不良事件明显更多，但均较轻微，72小时内消退。
在养老院老年人中，皮内注射疫苗在免疫原性评估的某些方面不劣于甚至优于肌内注射疫苗，且不影响安全性。皮内注射疫苗是该人群肌内注射疫苗的良好替代方案。
