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免疫橋接的RealWorldData(抗體效價與保護力之關係)

終焉ヲ謳ウ翼天者 | 2021-07-02 16:52:15 | 巴幣 0 | 人氣 253

https://doi.org/10.1038/s41586-020-2180-5
方法:分析了來自英國 ChAdOx1 nCoV-19 (AZ) 疫苗隨機療效試驗的數據,以確定與武漢肺炎保護力相關的抗體效價水平。
於受感染和未受感染的疫苗接受者打了第二針後 28 天,通過多重免疫測定、假病毒和活中和抗體測量抗尖峰和抗 RBD IgG試驗。,對來自AZ接受者的有症狀和無症狀武漢病毒感染數據,進行流行病學模型架構( Weighted generalised additive models for binary data),
並應用了權重(weights)來解釋樣品處理中的潛在選擇偏差(potential selection bias)。 模型根據暴露於 武漢病毒感染的風險baseline進行了調整

結果:高抗體效價正相關於減少染疫風險之保護力(
reduced risk of symptomatic infection). 80%的疫苗保護力相當於  antibody level of 40923 (95% CI: 16748, 125017) and 63383 (95% CI:16903, 無信賴區間) 於抗棘蛋白與抗RBD結合位置(receptor-binding domain)
185 (95% CI: NC, NC) and 247(95% CI: 101, NC) for pseudo- and live-neutralisation assays respectively. 而疫苗對無症狀感染保護力仍無法自此試驗看出,不過這也在研究者預料中.(畢竟疫苗主要是預防重症與hostpitalization)

The estimated anti-spike IgG level of 40923 AU/mL and the pseudo neutralising antibody
titre of 185 associated with 80% VE in our models, were similar to the GMTs of 48961
AU/mL and 237.0 respectively, previously reported in a subgroup of participants vaccinated
with AZ with a dose interval of at least 12 weeks between their 1st and 2nd
dose – a regimen that provided 80·0% (95% CI 65·2 to 88·5) vaccine efficacy in the pooled
analysis of data from the UK, Brazil and South Africa.

In contrast, no serological measurements were shown to correlate with protection against
asymptomatic infection or against symptomatic illness with only mild upper respiratory
symptoms. This was unsurprising and is consistent with our interim combined VE analysis
from UK and Brazil that vaccine efficacy against asymptomatic infection was 27.3% (−17.2 to
54.9) and was not significant at the 5% level.

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