Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults.
Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults.
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DOI：
10.1016/j.vaccine.2009.03.015
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发表时间：
2009-11-05
期刊：
影响因子：
5.5
通讯作者：
Hill H
中科院分区：
文献类型：
--
作者：
Keitel WA;Dekker CL;Mink C;Campbell JD;Edwards KM;Patel SM;Ho DY;Talbot HK;Guo K;Noah DL;Hill H
目前正在探索疫苗生产的剂量节省策略、佐剂和替代底物，以开发流感疫苗。我们评估了Vero细胞培养的灭活全病毒A/H5 N1流感疫苗（含或不含氢氧化铝佐剂[Al（OH）3]）在健康年轻人中的安全性和免疫原性。疫苗的耐受性良好，但注射部位不适是更频繁的组接受Al（OH）3。观察到血清抗体水平呈剂量相关性升高。当由两个不同的实验室检测时，中和抗体滴度变化显著。Al（OH）3不增强HAI或中和抗体应答，并导致注射部位疼痛增加。由于流感抗体滴度在不同的实验室之间差异很大，因此有必要对检测方法进行国际标准化。
Dosage-sparing strategies, adjuvants and alternative substrates for vaccine production are being explored for influenza vaccine development. We assessed the safety and immunogenicity of a Vero cell culture-grown inactivated whole virus influenza A/H5N1 vaccine with or without aluminum hydroxide adjuvant [Al(OH)3] in healthy young adults. Vaccines were well tolerated, but injection site discomfort was more frequent in groups receiving Al(OH)3. Dose-related increases in serum antibody levels were observed. Neutralizing antibody titers varied significantly when tested by two different laboratories. Al(OH)3 did not enhance HAI or neutralizing antibody responses, and contributed to increased injection site pain. Because influenza antibody titers vary significantly between different laboratories, international standardization of assays is warranted.
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