Development of a PIV-vectored RSV vaccine: Preclinical evaluation of safety, toxicity, and enhanced disease and initial clinical testing in healthy adults

被引：47

作者：

Tang, Roderick S. ^{[1
]}

Spaete, Richard R. ^{[1
]}

Thompson, Mark W. ^{[2
]}

MacPhail, Mia ^{[1
]}

Guzzetta, Jeanne M. ^{[1
]}

Ryan, Patricia C. ^{[3
]}

Reisinger, Keith ^{[4
]}

Chandler, Patricia

Hilty, Milo ^{[5
]}

Walker, Robert E. ^{[3
]}

Gomez, Margarita M. ^{[3
]}

Losonsky, Genevieve A. ^{[3
]}

机构：

[1] Medimmune Inc, Mountain View, CA 94043 USA

[2] Medimmune Inc, Santa Clara, CA 95054 USA

[3] Medimmune Inc, Gaithersburg, MD 20878 USA

[4] Primary Phys Res, Pittsburgh, PA 15241 USA

[5] Natl Childrens Hosp, Columbus, OH 43205 USA

来源：

VACCINE | 2008年 / 26卷 / 50期

关键词：

RSV; PIV3; Vaccine;

D O I：

10.1016/j.vaccine.2008.09.018

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

MEDI-534 is a bivalent live attenuated vaccine candidate against human respiratory syncytial virus (hRSV) and human parainfluenza virus type 3 (hPIV3) that was previously shown to be immunogenic and to protect rodents and African green monkeys from wild-type (wt) hRSV challenge. We performed further preclinical evaluations to address the safety of MEDI-534 prior to human testing. MEDI-534 did not predispose rodents to enhanced RSV disease following wt-RSV challenge, and the tissue tropism of the chimeric virus was confined to the respiratory tract. Representative clinical trial material did not produce toxicity in rats. In adults, MEDI-534 was highly restricted in replication, did not boost RSV and PIV3 antibody titers, and produced no medically significant vaccine-related adverse events thereby warranting further evaluation in pediatric populations. (c) 2008 Elsevier Ltd. All rights reserved.

引用

页码：6373 / 6382

页数：10

共 32 条

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