Immunogenicity and safety of IXIARO® (IC51) in a Phase II study in healthy Indian children between 1 and 3 years of age

被引：40

作者：

Kaltenboeck, A. ^{[1
]}

Dubischar-Kastner, K. ^{[1
]}

Schuller, E. ^{[1
]}

Datla, Mahima ^{[2
]}

Klade, C. S. ^{[1
]}

Kishore, T. S. A. ^{[2
]}

机构：

[1] Intercell AG, A-1030 Vienna, Austria

[2] Biol E Ltd, Hyderabad 500020, Andhra Pradesh, India

来源：

VACCINE | 2010年 / 28卷 / 03期

关键词：

IXIARO (R); IC51; Japanese encephalitis; Paediatric population; JAPANESE ENCEPHALITIS; NEUTRALIZING ANTIBODY; VACCINE IC51; GELATIN; HOLIDAY; BLIND;

D O I：

10.1016/j.vaccine.2009.10.024

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

For adults the standard administration of the Japanese encephalitis vaccine IXIARO (R) is two injections of 6 mu g in a 28-day interval. Immunogenicity and safety of 3 and 6 mu g of IXIARO (R) compared to JenceVac (TM) were investigated in 60 healthy Indian children aged between 1 and 3 years. JE specific neutralizing antibodies were measured at baseline and 28 days after the first and second vaccination. On Day 56 SCR of the 3 and 6 mu g IXIARO (R) and the JenceVac (TM) group were 95.7%, 95.2% and 90.9%, respectively, and GMT were 201, 218 and 230, respectively, both without statistically significant difference between the three groups Local and systemic tolerability were captured in a diary 7 days post-vaccination No apparent difference was seen in the safety profile between the vaccines These first immunogenicity and safety data in children are promising and support the use of a 3 mu g dose in children below the age of three for further development of IXIARO (R) in the paediatric population. (C) 2009 Elsevier Ltd All rights reserved

引用

页码：834 / 839

页数：6

共 24 条

[1] Fatal Japanese encephalitis in a Danish tourist visiting Bali for 12 days [J].