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J Infect Dis:重组泡状口炎病毒-扎伊尔埃博拉病毒包膜糖蛋白疫苗的免疫原性、异质性和安全性分析

2020-07-26 MedSci原创 MedSci原创

这项双盲研究评估了重组泡状口炎病毒-扎伊尔埃博拉病毒包膜糖蛋白疫苗(rVSVΔG-ZEBOV-GP)的免疫原性、批次一致性和安全性。

这项双盲研究评估了重组泡状口炎病毒-扎伊尔埃博拉病毒包膜糖蛋白疫苗(rVSVΔG-ZEBOV-GP)的免疫原性、批次一致性和安全性。

 

1197名健康成人随机2:2:2:2:1接受3个一致性批次的rVSVΔG-ZEBOV-GP(2×107斑块形成单位[pfu])、高剂量1×108 pfu或安慰剂中的1个。对接种前/接种后(28天,6个月;在一个子集[n = 566]中,12、18和24个月)的抗体反应进行了测量。

 

结果显示,ZEBOV-GP酶联免疫吸附试验(ELISA)几何平均滴度(GMTs)在所有rVSVΔG-ZEBOV-GP组中接种后增加28天(>58倍),并持续到24个月。3个生产批次在28天时表现出同等的免疫原性。在所有rVSVΔG-ZEBOV-GP组中,中和抗体GMTs在28天内增加,在18个月内达到峰值,24个月内没有下降。28天时,≥94%的受种者血清反应(ZEBOV-GP ELISA,增加≥2倍,滴度≥200 EU/mL),24个月时≥91%的受种者反应持续。女性性别和关节炎病史是疫苗接种后关节炎发生的潜在危险因素。

 

综上所述,该研究结果表明,对rVSVΔG-ZEBOV-GP的免疫反应持续到24个月。免疫原性和安全性结果支持继续开发rVSVΔG-ZEBOV-GP。

 

原始出处:

 

Scott A Halperin, Rituparna Das, et al., Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults. J Infect Dis. 2019 Aug 30;220(7):1127-1135. doi: 10.1093/infdis/jiz241.

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