What Is the Predictive Value of Animal Models for Vaccine Efficacy in Humans? The Importance of Bridging Studies and Species-Independent Correlates of Protection

被引：48

作者：

Golding, Hana ^{[1
]}

Khurana, Surender ^{[1
]}

Zaitseva, Marina ^{[1
]}

机构：

[1] US FDA, Div Viral Prod, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA

来源：

COLD SPRING HARBOR PERSPECTIVES IN BIOLOGY | 2018年 / 10卷 / 04期

关键词：

EBOLA HEMORRHAGIC-FEVER; HUMAN IMMUNODEFICIENCY VIRUSES; HIV-1; VACCINE; NONHUMAN-PRIMATES; DOUBLE-BLIND; CYNOMOLGUS MACAQUES; INFECTION; IMMUNITY; ENVELOPE; MARBURG;

D O I：

10.1101/cshperspect.a028902

中图分类号：

Q2 [细胞生物学];

学科分类号：

071009 ; 090102 ;

摘要：

Animal models have played a pivotal role in all stages of vaccine development. Their predictive value for vaccine effectiveness depends on the pathogen, the robustness of the animal challenge model, and the correlates of protection (if known). This article will cover key questions regarding bridging animal studies to efficacy trials in humans. Examples include human papillomavirus (HPV) vaccine in which animal protection after vaccination with heterologous prototype virus-like particles (VLPs) predicted successful efficacy trials in humans, and a recent approval of anthrax vaccine in accordance with the "Animal Rule." The establishment of animal models predictive of vaccine effectiveness in humans has been fraught with difficulties with low success rate to date. Challenges facing the use of animal models for vaccine development against Ebola and HIV will be discussed.

引用

页数：12

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