PHASE-I STUDY MEDI-534, OF A LIVE, ATTENUATED INTRANASAL VACCINE AGAINST RESPIRATORY SYNCYTIAL VIRUS AND PARAINFLUENZA-3 VIRUS IN SEROPOSITIVE CHILDREN

被引：51

作者：

Gomez, Margarita ^{[1
]}

Mufson, Maurice A. ^{[2
]}

Dubovsky, Filip ^{[1
]}

Knightly, Conor ^{[1
]}

Zeng, Wen ^{[1
]}

Losonsky, Genevieve ^{[1
]}

机构：

[1] MedImmune LLC, Gaithersburg, MD 20878 USA

[2] Univ Phys Internal Med, Huntington, WV USA

来源：

PEDIATRIC INFECTIOUS DISEASE JOURNAL | 2009年 / 28卷 / 07期

关键词：

RSV; PIV3; vaccine; children; safety profile; ENHANCED DISEASE; TYPE-3; INFECTION; INFANTS;

D O I：

10.1097/INF.0b013e318199c3b1

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

A live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine was evaluated in healthy respiratory syncytial virus/parainfluenza virus type 3 seropositive children aged I to 9 years. Three cohorts of 40 children were randomized 1:1 to receive 10(4), 10(5), or 10(6) median tissue culture infectious dose(50) MEDI-534 vaccine or placebo. The vaccine's safety profile was similar to placebo, no viral shedding was detected, and the vaccine was minimally immunogenic.

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页码：655 / 658

页数：4

相关论文

共 10 条

[1] Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old [J].

Belshe, RB ;

Newman, FK ;

Tsai, TF ;

Karron, RA ;

Reisinger, K ;

Roberton, D ;

Marshall, H ;

Schwartz, R ;

King, J ;

Henderson, FW ;

Rodriguez, W ;

Severs, JM ;

Wright, PF ;

Keyserling, H ;

Weinberg, GA ;

Bromberg, K ;

Loh, R ;

Sly, P ;

McIntyre, P ;

Ziegler, JB ;

Hackell, J ;

Deatly, A ;

Georgiu, A ;

Paschalis, M ;

Wu, SL ;

Tatem, JM ;

Murphy, B ;

Anderson, E .

JOURNAL OF INFECTIOUS DISEASES, 2004, 189 (03) :462-470

[2] Expression of the surface glycoproteins of human parainfluenza virus type 3 by bovine parainfluenza virus type 3, a novel attenuated virus vaccine vector [J].

Haller, AA ;

Miller, T ;

Mitiku, M ;

Coelingh, K .

JOURNAL OF VIROLOGY, 2000, 74 (24) :11626-11635

[3] A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants [J].

Karron, RA ;

Belshe, RB ;

Wright, PF ;

Thumar, B ;

Burns, B ;

Newman, F ;

Cannon, JC ;

Thompson, J ;

Tsai, T ;

Paschalis, M ;

Wu, SL ;

Mitcho, Y ;

Hackell, J ;

Murphy, BR ;

Tatem, JM .

PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2003, 22 (05) :394-405

[4] A LIVE HUMAN PARAINFLUENZA TYPE-3 VIRUS-VACCINE IS ATTENUATED AND IMMUNOGENIC IN HEALTHY INFANTS AND CHILDREN [J].

KARRON, RA ;

WRIGHT, PF ;

NEWMAN, FK ;

MAKHENE, M ;

THOMPSON, J ;

SAMORODIN, R ;

WILSON, MH ;

ANDERSON, EL ;

CLEMENTS, ML ;

MURPHY, BR ;

BELSHE, RB .

JOURNAL OF INFECTIOUS DISEASES, 1995, 172 (06) :1445-1450

[5] Medical Burden of Respiratory Syncytial Virus and Parainfluenza Virus Type 3 Infection Among US Children Implications for Design of Vaccine Trials [J].

Lee, Min-Shi ;

Walker, Robert E. ;

Mendelman, Paul M. .

HUMAN VACCINES, 2005, 1 (01) :6-11

[6] Live-attenuated virus vaccines for respiratory syncytial and parainfluenza viruses: applications of reverse genetics [J].

Murphy, BR ;

Collins, PL .

JOURNAL OF CLINICAL INVESTIGATION, 2002, 110 (01) :21-27

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

Tang, Roderick S. ;

Spaete, Richard R. ;

Thompson, Mark W. ;

MacPhail, Mia ;

Guzzetta, Jeanne M. ;

Ryan, Patricia C. ;

Reisinger, Keith ;

Chandler, Patricia ;

Hilty, Milo ;

Walker, Robert E. ;

Gomez, Margarita M. ;

Losonsky, Genevieve A. .

VACCINE, 2008, 26 (50) :6373-6382

[8] Parainfluenza virus type 3 expressing the native or soluble fusion (F) protein of respiratory syncytial virus (RSV) confers protection from RSV infection in African green monkeys [J].

Tang, RS ;

MacPhail, M ;

Schickli, JH ;

Kaur, J ;

Lawlor, HA ;

Guzzetta, JM ;

Spaete, RR ;

Haller, AA .

JOURNAL OF VIROLOGY, 2004, 78 (20) :11198-11207

[9] Effects of human metapneumovirus and respiratory syncytial virus antigen insertion in two 3′ proximal genome positions of bovine/human parainfluenza virus type 3 on virus replication and immunogenicity [J].

Tang, RS ;

Schickli, JH ;

MacPhail, M ;

Fernandes, F ;

Bicha, L ;

Spaete, J ;

Fouchier, RAM ;

Osterhaus, ADME ;

Spaete, R ;

Haller, AA .

JOURNAL OF VIROLOGY, 2003, 77 (20) :10819-10828

[10] The absence of enhanced disease with wild type respiratory syncytial virus infection occurring after receipt of live, attenuated, respiratory syncytial virus vaccines [J].

Wright, Peter F. ;

Karron, Ruth A. ;

Belshe, Robert B. ;

Shi, Jian R. ;

Randolph, Valerie B. ;

Collins, Peter L. ;

O'Shea, Alice F. ;

Gruber, William C. ;

Murphy, Brian R. .

VACCINE, 2007, 25 (42) :7372-7378