Ohfuji Satoko, Kobayashi Masayuki, Ide Yuichiro, Egawa Yumi, Saito Tomoko, Kondo Kyoko, Ito Kazuya, Kase Tetsuo, Maeda Akiko, Fukushima Wakaba, Hirota Yoshio
Department of Public Health, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka-city, Osaka 545-8585, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka-city, Osaka 545-8585, Japan.
Medical Affairs, MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-0073, Japan.
Vaccine. 2017 Sep 18;35(39):5303-5308. doi: 10.1016/j.vaccine.2017.07.092. Epub 2017 Aug 4.
Immunogenicity studies on pandemic influenza vaccine are necessary to inform rapid development and implementation of a vaccine during a pandemic. Thus, strategies for immunogenicity assessment are required.
To identify essential factors to consider when evaluating the immunogenicity of pandemic influenza vaccines using the experience in Japan with the influenza A(H1N1)pdm09 vaccine.
We conducted a search of observational studies using PubMed and IchushiWeb. Search terms included "influenza vaccine AND (immunogenicity OR immune response) AND Japan AND (2009 OR pdm09) NOT review," and was limited to studies conducted in humans.
A total of 33 articles were identified, of which 16 articles met the inclusion criteria. Immunogenicity of the commercially available influenza A(H1N1)pdm09 vaccine satisfied the international criteria for influenza vaccine immunogenicity in all study populations. The most remarkable immune response was observed in junior high school students, while the lowest immune response was observed in hematological malignancy patients. Similar to immunogenicity studies on seasonal influenza vaccines, factors such as patient background (e.g., age, underlying condition, pre-vaccination titer, body mass index, etc.) and study procedure (e.g., concurrent measurement of pre- and post-vaccination antibody titer, effects of infection during the study period) may have affected the assessment of immunogenicity to the influenza A(H1N1)pdm09 vaccine. In addition, prior vaccination with the seasonal influenza vaccine may inhibit antibody induction by the influenza A(H1N1)pdm09 vaccine.
This review discusses factors and strategies that must be considered and addressed during immunogenicity assessments of pandemic influenza vaccines, which may provide useful information for future influenza pandemics.
大流行性流感疫苗的免疫原性研究对于在大流行期间为疫苗的快速研发和应用提供依据至关重要。因此，需要免疫原性评估策略。
利用日本甲型H1N1流感大流行疫苗的经验，确定评估大流行性流感疫苗免疫原性时需要考虑的关键因素。
我们使用PubMed和IchushiWeb对观察性研究进行了检索。检索词包括“流感疫苗 AND（免疫原性或免疫反应） AND 日本 AND（2009或pdm09） NOT 综述”，且仅限于在人类中进行的研究。
共确定了33篇文章，其中16篇符合纳入标准。在所有研究人群中，市售甲型H1N1流感大流行疫苗的免疫原性均符合流感疫苗免疫原性的国际标准。初中生中观察到最显著的免疫反应，而血液系统恶性肿瘤患者中观察到的免疫反应最低。与季节性流感疫苗的免疫原性研究类似，患者背景（如年龄、基础疾病、接种前滴度、体重指数等）和研究程序（如接种前后抗体滴度的同步测量、研究期间感染的影响）等因素可能影响了对甲型H1N1流感大流行疫苗免疫原性的评估。此外，先前接种季节性流感疫苗可能会抑制甲型H1N1流感大流行疫苗诱导抗体。
本综述讨论了在大流行性流感疫苗免疫原性评估期间必须考虑和解决的因素及策略，这可能为未来的流感大流行提供有用信息。
