Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children

被引：9

作者：

Chokephaibulkit, Kulkanya ^{[1
,7
]}

Sirivichayakul, Chukiat ^{[2
]}

Thisyakorn, Usa ^{[3
,8
]}

Pancharoen, Chitsanu ^{[3
,8
]}

Boaz, Mark ^{[4
,9
,10
]}

Bouckenooghe, Alain ^{[5
,11
]}

Feroldi, Emmanuel ^{[6
]}

机构：

[1] Mahidol Univ, Siriraj Hosp, Fac Med, Div Infect Dis, Bangkok, Thailand

[2] Mahidol Univ, Fac Trop Med, Dept Trop Pediat, 420-6 Ratchawithi Rd, Bangkok 10400, Thailand

[3] Chulalongkorn Hosp, Dept Pediat, Bangkok, Thailand

[4] Sanofi Pasteur, Global Clin Immunol, Swiftwater, PA USA

[5] Sanofi Pasteur, Med Affairs & Clin Sci, Singapore, Singapore

[6] Sanofi Pasteur, Clin Sci, 1541 Ave Marcel Merieux, F-69280 Marcy Letoile, France

[7] Mahidol Univ, Siriraj Hosp, Fac Med, Dept Pediat, 2 Wanglang Rd, Bangkok 10700, Thailand

[8] 1873 Rama 4 Rd, Bangkok 10330, Thailand

[9] 1 Discovery Dr, Swiftwater, PA 18370 USA

[10] Int AIDS Vaccine Initiat, New York, NY USA

[11] 38 Beach Rd 18-11, Singapore 189767, Singapore

来源：

VACCINE | 2016年 / 34卷 / 46期

关键词：

Encephalitis virus; Japanese; Vaccine; Attenuated; Children; Immunization; Follow-up; SAFETY; IMMUNOGENICITY;

D O I：

10.1016/j.vaccine.2016.09.018

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: A single dose of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) was shown to be immunogenic and well tolerated when given either as a booster to formalin-inactivated Japanese encephalitis (JE)-vaccine (mouse brain-derived vaccine [MBDV])-primed 2-5-year-olds, or as a primary vaccination to JE-vaccine-naive 12-24-month-old toddlers in Thailand. A 5-year follow-up assessment of immune response persistence over time was conducted. Methods: Four additional visits (at 2, 3, 4, and 5 years) for immunologic assessments were added to the original 12-month open-label crossover study, in which 100 healthy children aged 2-5 years with a history of two-dose primary vaccination with MBDV (according to the Thai Expanded Program for Immunization schedule), and 200 healthy JE-vaccine-naive 12-24-month-old toddlers, were randomized 1:1 to receive JE-CV, containing >= 4 log(10) plaque forming units, I month before or after hepatitis A control vaccine. Results: In MBDV-primed 2-5-year-olds (n = 78), the immune response to the JE-CV vaccine persisted up to at least 5 years after vaccination with a single dose of JE-CV, with all (n = 78) children seroprotected at the year 5 visit (geometric mean titers [GMT]: 252 1/dil). There was no decrease of seroprotection rate over time (100% at 6 months post-vaccination and 96.8% (90.3-98.9) at 5 years post-vaccination). In JE-vaccine-naive toddlers, a protective immune response persisted up to at least 5 years in 58.8% (50.9-66.4) after a single -dose administration of JE-CV (GMT 26.7 1/dil; sensitivity analysis). Conclusions: A single -dose of JE-CV as a booster following MBDV administration provided long-lasting immunity. In JE-vaccine-naive toddlers, despite relatively high seroprotection rates persisting over time, a subsequent booster dose is recommended following a JE-CV primary vaccination for long-term protection. (C) 2016 Elsevier Ltd. All rights reserved.

引用

页码：5664 / 5669

页数：6

共 11 条

[1] Safety and Immunogenicity of a Single Administration of Live-attenuated Japanese Encephalitis Vaccine in Previously Primed 2-to 5-year-olds and Naive 12-to 24-month-olds Multicenter Randomized Controlled Trial [J].