Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO®, IC51

被引：42

作者：

Eder, Susanne ^{[2
]}

Dubischar-Kastner, Katrin ^{[2
]}

Firbas, Christa ^{[1
]}

Jelinek, Tomas ^{[4
]}

Jilma, Bernd ^{[1
]}

Kaltenboeck, Astrid ^{[2
]}

Knappik, Michael ^{[4
]}

Kollaritsch, Herwig ^{[3
]}

Kundi, Michael ^{[5
]}

Paulke-Korinek, Maria ^{[3
]}

Schuller, Elisabeth ^{[2
]}

Klade, Christoph S. ^{[2
]}

机构：

[1] Med Univ Vienna, Dept Clin Pharmacol, A-1090 Vienna, Austria

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

[3] Med Univ Vienna, Dept Specif Prophylaxis & Trop Med, A-1090 Vienna, Austria

[4] Ctr Travel & Trop Med, Berlin, Germany

[5] Med Univ Vienna, Ctr Publ Hlth, Inst Environm Hlth, A-1090 Vienna, Austria

来源：

VACCINE | 2011年 / 29卷 / 14期

关键词：

Japanese Encephalitis virus; Vaccination; Phase III clinical trial; Ixiaro; Jespect; TICK-BORNE ENCEPHALITIS; CONTROLLED PHASE-3; ANTIBODY-RESPONSE; IMMUNOGENICITY; SAFETY; IMMUNIZATION; SINGLE; VIRUS; TRIAL; PERSISTENCE;

D O I：

10.1016/j.vaccine.2011.01.058

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Introduction: IXIARO (IC51), a recently approved inactivated Japanese Encephalitis vaccine, is immunogenic and safe in a 0/28 days primary immunization schedule. Neutralizing antibody titers decline with time and booster doses are likely needed to enhance persistence of immunity. Objectives: To assess the effect of a booster dose on neutralizing JE antibody titers for up to 12 months after boostering. Methods: In this phase III trial, 198 subjects, who had received primary immunization in a preceding randomized trial, were boosted with IXIARO 15 months after the primary immunization. Neutralizing antibody titers were assessed by plaque-reduction neutralisation test, PRNT. Results: Prior to the booster dose, 69.2% (137/198) of subjects had PRNT50 titers >= 1:10. One month after the booster, the rate of subjects with PRNT50 >= 1:10 (recognized as a protective titer) was 100%. This rate remained high at 98.5% at 6 and 12 months; GMTs were 22.5 before the booster and 900.487 and 361 at 1, 6 and 12 months after the booster, respectively. Conclusion: A booster dose of IXIARO at 15 months after primary immunization was highly immunogenic with GMTs >5-fold higher than those seen immediately after primary immunization, and remained at high levels for at least 12 months after the booster. NCT00595309. (C) 2011 Elsevier Ltd. All rights reserved.

引用

页码：2607 / 2612

页数：6

共 27 条

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