[Immunogenicity and safety of concomitant inoculation of Measles and rubella combined live vaccine and Japanese encephalitis attenuated live vaccine].

Article

作者: Deng, X ; He, H Q ; Tang, X W ; Zhou, Y ; Yan, R

目的： 分析浙江省8月龄儿童同时接种麻疹风疹联合减毒活疫苗和乙型脑炎减毒活疫苗的免疫原性和安全性。 方法： 选定浙江省两市满8月龄健康儿童，将儿童采用随机分组方法分配至麻疹风疹联合减毒活疫苗和乙型脑炎减毒活疫苗联合接种组（试验组），麻疹风疹联合减毒活疫苗单独接种组（对照组）。分别在疫苗接种前和疫苗接种后的6周采集儿童的静脉血1 ml，检测麻疹、风疹的血清中抗体浓度，评价疫苗接种前后的麻疹、风疹抗体水平；同时对联合接种的安全性进行评价。采用酶联免疫试验方法（ELISA）测定麻疹、风疹IgG抗体，分析同时接种麻疹风疹联合减毒疫苗和乙型脑炎减毒活疫苗的免疫原性和安全性。 结果： 共纳入符合方案的研究对象504名，其中试验组和对照组均为252名。试验组两种疫苗同时接种后麻疹抗体阳性率98.41%，阳转率96.43%，抗体几何平均浓度（GMC）为1 539.94 mIU/ml，疫苗接种后风疹抗体阳性率89.29%，阳转率88.49%，GMC为47.65 mIU/ml；对照组疫苗接种麻疹抗体阳性率98.02%，阳转率97.62%，GMC为1 428.96 mIU/ml，疫苗接种后风疹抗体阳性率86.51%，阳转率86.11%，GMC为45.66 mIU/ml，两组间GMC差异无统计学意义，试验组疫苗接种后麻疹、风疹抗体阳性率、阳转率非劣效于对照组。对研究对象接种疫苗后开展安全性观察，均具有较高的安全性，未发现相关严重不良反应事件，以一般反应为主，且预后良好。对试验组和对照组两组间的不良反应发生率进行比较，无统计学差异。 结论： 8月龄联合接种麻疹风疹减毒活疫苗和乙型脑炎减毒活疫苗具有良好的安全性和免疫原性。.

2017-01-01·Vaccine3区 · 医学

Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand

3区 · 医学

Article

作者: Tangsathapornpong, Auchara ; Pancharoen, Chitsanu ; Prommalikit, Olarn ; Techasaensiri, Chonnamet ; Tangkittithaworn, Suwimon ; Pruekprasert, Pornpimol ; Kerdpanich, Phirangkul ; Chotpitayasunondh, Tawee ; Houillon, Guy ; Chuenkitmongkol, Sunate ; Kosalaraksa, Pope ; Oberdorfer, Peninnah ; Korejwo, Joanna ; Puthanakit, Thanyawee

BACKGROUNDJapanese encephalitis is a mosquito-borne viral disease endemic in most countries in Asia. A recombinant live, attenuated Japanese encephalitis virus vaccine, JE-CV, is licensed in 14 countries, including Thailand, for the prevention of Japanese encephalitis in adults and children.METHODSThis was a prospective, phase IV, open-label, multicentre, safety study of JE-CV conducted from November 2013 to April 2015, to evaluate rare serious adverse events (AEs). JE-CV was administered to 10,000 healthy children aged 9months to <5years in Thailand as a primary (Group 1) or booster (Group 2) vaccination. Serious AEs (SAEs), including AEs of special interest, up to 60days after administration were evaluated. Immediate Grade 3 systemic AEs up to 30min after JE-CV administration were also described.RESULTSThe median age of participants was 1.1years in Group 1 and 3.8years in Group 2. SAEs were reported in 204 (3.0%) participants in Group 1 and 59 (1.9%) participants in Group 2. Among a total of 294 SAEs in 263 participants, only three events occurring in two participants were considered related to vaccination. All three cases were moderate urticaria, none of which met the definition of AEs of special interest for hypersensitivity. AEs of special interest were reported in 28 (0.4%) participants in Group 1 and 4 (0.1%) participants in Group 2; none were considered related to vaccination. Febrile convulsion was the most frequently reported AE of special interest: 25 (0.4%) participants in Group 1; and 2 (<0.1%) in Group 2. There were no cases of Japanese encephalitis reported. No Grade 3 immediate systemic AEs were reported after any JE-CV vaccination.CONCLUSIONSOur study did not identify any new safety concerns with JE-CV and confirms its good safety profile. This study was registered on www.clinicaltrials.gov (NCT01981967; Universal Trial Number: U1111-1127-7052).

Signal Transduction and Targeted Therapy1区 · 医学

The molecular determinants governing the immunogenicity of Japanese encephalitis live attenuated vaccines

1区 · 医学

ArticleOA

作者: Liu, Xinyu ; Li, Xuguang ; Yu, Yongxin ; Yang, Huiqiang ; Fu, Yin ; Li, Yuhua ; Farnsworth, Aaron ; Wang, Junzhi ; Jia, Lili

AbstractIn the course of isolating the attenuated Japanese encephalitis vaccine SA14-14-2, two attenuated strains SA14-9-7 and SA14-5-3 were also obtained that elicited low antibody responses in humans (<10% and 62%, respectively) and exerted much weaker immune protection in animal challenge experiments. However, the reason for these differences remains unknown. In order to understand why SA14-14-2 is superior to SA14-9-7 and SA14-5-3, we employed a reverse genetics method to identify the key mutations in the virus genome that determine the immunogenicity of live attenuated Japanese encephalitis viruses. We first sequenced the full genomic sequences of SA14-9-7 and SA14-5-3 and found mutations that changed four amino-acid base pairs when compared to the envelope gene of SA14-14-2. We mutated the genome of SA14-14-2 to generate these mutations both singly (E-177, E-264, E-279 and E-315) and in combination (E-177/264, E-279/315 and E-177/264/279/315) and tested these mutants along with parental strains SA14-14-2, SA14-9-7 and SA14-5-3 for their immunogenicity in vivo. When mice were immunized with SA14-9-7 and SA14-5-3, lower levels of neutralizing antibodies were generated compared with the immune response to SA14-14-2. Furthermore, SA14-5-3 was more immunogenic than SA14-9-7, which replicated the results previously seen in humans. Point mutations E-177, E-264, E-279 and E-315 diminished the immunogenicity of SA14-14-2 with E-264 and E-315, contributing the most to this phenotype. The mutant rJEV (E-177/E-264/E-279/E-315) containing all four point mutations exhibited the lowest immunogenicity with a seroconversion rate of 0 at an inoculation dose of 103 PFU (plaque-forming unit). We have identified the key amino acids in the envelope protein that account for the superior immunogenicity of SA14-14-2.

100 项与乙型脑炎减毒活疫苗 (兰州生物制品研究所) 相关的药物交易

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