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免疫原性（Immunogenicity）是指某抗原或其表位能作用于T细胞、B细胞的抗原识别受体，进而诱导机体产生体液和/或细胞介导免疫应答的特性；此抗原则可称为免疫原（immunogen）。蛋白质具有最强的免疫原性，其次是多糖；而脂质与核酸一般并不能成为免疫原，常常要借由与蛋白质结合才能激活免疫应答反应。

任何具有免疫原性的物质，即免疫原，必定是一种抗原，所以也会具有抗原性（antigenicity）；但具抗原性的物质，即抗原，不一定会有免疫原性。例如青霉素虽具有抗原性，但却无法刺激机体产生免疫应答，因此青霉素缺乏免疫原性。

免疫原性可以分为希望获得型和不希望获得型：

希望获得型免疫原性（Wanted immunogenicity）通常与疫苗相关。施打疫苗促使免疫应答发生，并于体内产生抗体，从而达到预防或保护的效果。疫苗研发是一个非常复杂的过程，通常会有几个阶段，而免疫原性是其中验证有效性的核心环节。^[1]
不希望获得型免疫原性（Unwanted immunogenicity）则是某一器官对某一治疗性抗原产生的免疫应答（例如：重组蛋白、单克隆抗体）。这一反应将会产生抗药物抗体（ADA），将会使药物失去疗效，并有可能引发不良反应。^[2]

生物疗法的一项挑战就是预测新型蛋白质疗法的免疫原性潜力。^[3]例如，来自于高收入国家的免疫原性数据可能就不适用于中低收入国家。^[4]另外一项挑战在于疫苗的免疫原性是否根据年龄的变化而变化。^[5]^[6]因此，正如世界卫生组织所称，由于动物实验和in-vitro模型并不能精确地预测人体的免疫应答，免疫原性的研究应该在一个特定的人群中进行。^[7]

参考文献

^ Leroux-Roels, Geert; Bonanni, Paolo; Tantawichien, Terapong; Zepp, Fred. Vaccine development. Perspectives in Vaccinology. August 2011, 1 (1): 115–150. doi:10.1016/j.pervac.2011.05.005 .
^ De Groot, Anne S.; Scott, David W. Immunogenicity of protein therapeutics. Trends in Immunology. November 2007, 28 (11): 482–490. PMID 17964218. doi:10.1016/j.it.2007.07.011.
^ Baker, Matthew; Reynolds, Helen M.; Lumicisi, Brooke; Bryson, Christine J. Immunogenicity of protein therapeutics: The key causes, consequences and challenges. Self/Nonself. October 2010, 1 (4): 314–322. PMC 3062386 . PMID 21487506. doi:10.4161/self.1.4.13904.
^ Lindsey, Benjamin B; Armitage, Edwin P; Kampmann, Beate; de Silva, Thushan I. The efficacy, effectiveness, and immunogenicity of influenza vaccines in Africa: a systematic review. The Lancet Infectious Diseases. April 2019, 19 (4): e110–e119. PMID 30553695. doi:10.1016/S1473-3099(18)30490-0. hdl:10044/1/65398 .
^ Nic Lochlainn, Laura M; de Gier, Brechje; van der Maas, Nicoline; Strebel, Peter M; Goodman, Tracey; van Binnendijk, Rob S; de Melker, Hester E; Hahné, Susan J M. Immunogenicity, effectiveness, and safety of measles vaccination in infants younger than 9 months: a systematic review and meta-analysis. The Lancet Infectious Diseases. November 2019, 19 (11): 1235–1245. PMC 6838664 . PMID 31548079. doi:10.1016/S1473-3099(19)30395-0.
^ Samson, Sandrine I.; Leventhal, Phillip S.; Salamand, Camille; Meng, Ya; Seet, Bruce T.; Landolfi, Victoria; Greenberg, David; Hollingsworth, Rosalind. Immunogenicity of high-dose trivalent inactivated influenza vaccine: a systematic review and meta-analysis. Expert Review of Vaccines. 4 March 2019, 18 (3): 295–308. PMID 30689467. doi:10.1080/14760584.2019.1575734.
^ WHO. WHO Expert Committee on Biological Standardization. World Health Organization. 2014. ISBN 978-92-4-069262-6. OCLC 888748977. ^{[页码请求]}

[1] Leroux-Roels, Geert; Bonanni, Paolo; Tantawichien, Terapong; Zepp, Fred. Vaccine development. Perspectives in Vaccinology. August 2011, 1 (1): 115–150. doi:10.1016/j.pervac.2011.05.005 .

[2] De Groot, Anne S.; Scott, David W. Immunogenicity of protein therapeutics. Trends in Immunology. November 2007, 28 (11): 482–490. PMID 17964218. doi:10.1016/j.it.2007.07.011.

[3] Baker, Matthew; Reynolds, Helen M.; Lumicisi, Brooke; Bryson, Christine J. Immunogenicity of protein therapeutics: The key causes, consequences and challenges. Self/Nonself. October 2010, 1 (4): 314–322. PMC 3062386 . PMID 21487506. doi:10.4161/self.1.4.13904.

[4] Lindsey, Benjamin B; Armitage, Edwin P; Kampmann, Beate; de Silva, Thushan I. The efficacy, effectiveness, and immunogenicity of influenza vaccines in Africa: a systematic review. The Lancet Infectious Diseases. April 2019, 19 (4): e110–e119. PMID 30553695. doi:10.1016/S1473-3099(18)30490-0. hdl:10044/1/65398 .

[5] Nic Lochlainn, Laura M; de Gier, Brechje; van der Maas, Nicoline; Strebel, Peter M; Goodman, Tracey; van Binnendijk, Rob S; de Melker, Hester E; Hahné, Susan J M. Immunogenicity, effectiveness, and safety of measles vaccination in infants younger than 9 months: a systematic review and meta-analysis. The Lancet Infectious Diseases. November 2019, 19 (11): 1235–1245. PMC 6838664 . PMID 31548079. doi:10.1016/S1473-3099(19)30395-0.

[6] Samson, Sandrine I.; Leventhal, Phillip S.; Salamand, Camille; Meng, Ya; Seet, Bruce T.; Landolfi, Victoria; Greenberg, David; Hollingsworth, Rosalind. Immunogenicity of high-dose trivalent inactivated influenza vaccine: a systematic review and meta-analysis. Expert Review of Vaccines. 4 March 2019, 18 (3): 295–308. PMID 30689467. doi:10.1080/14760584.2019.1575734.

[7] WHO. WHO Expert Committee on Biological Standardization. World Health Organization. 2014. ISBN 978-92-4-069262-6. OCLC 888748977. ^{[页码请求]}

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