کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10969581 | 1102968 | 2011 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The safety evaluation of adjuvants during vaccine development: The AS04 experience
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کلمات کلیدی
SAEVAERSMPLHSVAdjuvant - ادجوانت، یاورSafety - ایمنیMAE - بلهadjuvant System - سیستم کمکیVaccine Adverse Event Reporting System - سیستم گزارش رویداد ناخواسته واکسنadverse event - عارضه جانبی یا عوارض جانبیSerious adverse event - عوارض جانبی جدیHBV - هپاتیت بVaccine - واکسنherpes simplex virus - ویروس هرپس سیمپلکسhepatitis B virus - ویروس هپاتیت بیHuman papillomavirus - ویروس پاپیلوم انسانیHPV - ویروس پایپلوم انسانی
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Novel adjuvants that contain immunoenhancer molecules are now present in human vaccines either registered or in clinical trials. These adjuvants have the potential to provide clear benefits in improving the magnitude and duration of various aspects of the adaptive immune response. However, the use of immunoenhancers in vaccine formulations may be perceived as introducing theoretical safety risks that need to be addressed during the course of vaccine development. In addition to classical clinical safety evaluation, the licensing authorities recommend that novel adjuvants should be evaluated in non-clinical toxicology studies, both as separate entities and as part of the final vaccine formulation. We present here our approach for the safety evaluation of adjuvanted vaccines using AS04-adjuvanted vaccines as example. This evaluation consists of three tiers: non-clinical toxicology, adjuvant mode-of-action investigations and clinical safety assessment in controlled clinical trials and post-marketing surveillance. We also discuss how the knowledge of adjuvant mode of action can support the current practice of safety evaluation.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 29, Issue 27, 15 June 2011, Pages 4453-4459
Journal: Vaccine - Volume 29, Issue 27, 15 June 2011, Pages 4453-4459
نویسندگان
Nathalie Garçon, Lawrence Segal, Fernanda Tavares, Marcelle Van Mechelen,