Study designs for the nonclinical safety testing of new vaccine products

Journal of Pharmacological and Toxicological Methods
Roy Forster

Abstract

During the development of a new vaccine, the purpose of nonclinical studies is to provide safety information to support the clinical development and licensure of the product. In this article the study designs currently accepted for the nonclinical safety testing of new vaccines are described for single dose, local tolerance, repeat dose toxicity and safety pharmacology studies; these studies together form the basis of a typical nonclinical safety evaluation dossier. The detailed design of the preclinical package must take account of the intended clinical use, patient population, route of administration, formulation, dose level and immunisation schedule. The test item that is used for these studies must be adequately representative of the intended clinical formulation. The animal model used for these studies must be selected on criteria of relevance. Single dose toxicity studies provide information on acute actions or the potential effect of accidental overdose, but this information is often available from the repeat dose toxicity study, obviating the need for the acute study. Local tolerance studies provide information on tissue reactions at the site of administration. Evaluation of the findings must distinguish between normal ...Continue Reading

References

Jul 16, 2005·Expert Opinion on Biological Therapy·Steve Pascolo
May 23, 2006·Experimental and Toxicologic Pathology : Official Journal of the Gesellschaft Für Toxikologische Pathologie·Zuhal DincerRichard Haworth
Sep 11, 2010·Nature Biotechnology·Karen B GoetzChristian K Schneider
Jan 12, 2012·Journal of Pharmacological and Toxicological Methods·Paul Barrow
Feb 14, 2012·Journal of Pharmacological and Toxicological Methods·Yuansheng SunMineo Matsumoto

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Citations

Dec 22, 2012·Expert Review of Vaccines·Holly SandersGermie Pjm van den Dobbelsteen
Apr 11, 2013·Human Vaccines & Immunotherapeutics·Xiao-bing ZhouBo Li
Mar 13, 2014·International Immunopharmacology·Alexander Batista-DuharteIracilda Zeppone Carlos
Jun 1, 2016·Journal of Applied Toxicology : JAT·Harm HogenEschGarry Morefield
May 1, 2020·Viruses·Jerri C CaldeiraFederica Cavallo
Sep 22, 2017·Human Vaccines & Immunotherapeutics·Lisa D MacDonaldMarianne M Stanford
Oct 23, 2020·Journal of Medical Virology·Jinlei HeJianping Chen
Mar 19, 2020·Human Vaccines & Immunotherapeutics·Huayue YeFengcai Zhu
Apr 27, 2021·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Zhangqiong HuangQihan Li
Oct 27, 2021·Reviews in Medical Virology·Asghar AbdoliHasan Jalili

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