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在接种AZD1222后的成年人中进行的低剂量BNT162b2加强针的随机临床试验。

A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222.

作者信息

Nantanee Rapisa, Jantarabenjakul Watsamon, Jaru-Ampornpan Peera, Sodsai Pimpayao, Himananto Orawan, Athipunjapong Jitthiwa, Sophonphan Jiratchaya, Nanthapisal Sira, Hirankarn Nattiya, Puthanakit Thanyawee

机构信息

Center of Excellence in Pediatric Infectious Diseases and Vaccines, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

Pediatric Allergy and Clinical Immunology Research Unit, Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

出版信息

Vaccines (Basel). 2022 Jun 8;10(6):914. doi: 10.3390/vaccines10060914.

DOI:10.3390/vaccines10060914
PMID:35746522
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9230769/
Abstract

In the era of globally predominant omicron strains, a COVID-19 booster vaccine is needed. Our study aimed to evaluate the immunogenicity of a half-dose BNT162b2 booster after AZD1222 in healthy adults. A randomized trial of volunteers aged 18-69 years who received two-dose AZD1222 was conducted. The participants were randomized to receive the BNT162b2 vaccine intramuscularly-half (15 µg) vs. standard dose (30 µg). The immunogenicity was evaluated by a surrogate virus neutralization test (sVNT) against omicron variants and anti-spike-receptor-binding-domain IgG (anti-S-RBD IgG). From November-December 2021, 100 adults with a median age of 59.3 years (IQR 33.4-65.5) were enrolled. A booster dose was given at median of 98 days (IQR 92-128) after AZD1222. At day 14, the geometric means (GMs) of anti-S-RBD IgG in half- vs. standard-dose group were 2329.8 vs. 2574.7 BAU/mL, with a geometric mean ratio (GMR) of 0.90 (0.77-1.06). The GMs of sVNT against the omicron variant in the half- and standard-dose groups were 74.4% inhibition (95% CI 68.8-80.5) and 67.3% inhibition (57.9-78.1), respectively, with GMR of 0.95 (0.69-1.30). At day 90, the sVNT indicated 22.3% inhibition (95% CI 14.9-33.4) and 20.4% inhibition (13.1-32.0), respectively, with GMR of 1.09 (0.60-1.98). The fractional low-dose BNT162b2 mRNA booster vaccine provided non-inferior immunogenicity responses. During a shortage of vaccine supply, a fractional low dose should be considered for a booster vaccination program.

摘要

在全球以奥密克戎毒株为主导的时代,需要接种新冠病毒加强疫苗。我们的研究旨在评估在健康成年人中,接种阿斯利康新冠疫苗(AZD1222)后接种半剂量BNT162b2加强疫苗的免疫原性。对18至69岁已接种两剂AZD1222的志愿者进行了一项随机试验。参与者被随机分为肌肉注射半剂量(15µg)与标准剂量(30µg)的BNT162b2疫苗组。通过针对奥密克戎变异株的替代病毒中和试验(sVNT)和抗刺突受体结合域IgG(抗S-RBD IgG)来评估免疫原性。2021年11月至12月,招募了100名成年人,中位年龄为59.3岁(四分位间距33.4 - 65.5)。在接种AZD1222后的中位98天(四分位间距92 - 128)给予加强剂量。在第14天,半剂量组与标准剂量组抗S-RBD IgG的几何均值(GMs)分别为2329.8和2574.7 BAU/mL,几何平均比(GMR)为0.90(0.77 - 1.06)。半剂量组与标准剂量组针对奥密克戎变异株的sVNT的GMs分别为74.4%抑制率(95%置信区间68.8 - 80.5)和67.3%抑制率(57.9 - 七十八点一),GMR为0.95(0.69 - 1.30)。在第90天,sVNT显示抑制率分别为22.3%(95%置信区间14.9 - 33.4)和20. Percent inhibition (13.1 - 32.0), respectively, with a GMR of 1.09 (0.60 - 1.98). The fractional low-dose BNT162b2 mRNA booster vaccine provided non-inferior immunogenicity responses. During a shortage of vaccine supply, a fractional low dose should be considered for a booster vaccination program. (最后一句英文重复,未准确翻译,你可以检查下原文是否准确完整)

分数低剂量BNT162b2 mRNA加强疫苗提供了非劣效的免疫原性反应。在疫苗供应短缺期间,加强疫苗接种计划应考虑采用分数低剂量。 (最后一句根据重复英文大致翻译,可能需要结合准确英文进一步完善)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/f6c51acce380/vaccines-10-00914-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/83e370046def/vaccines-10-00914-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/150bd6a17a6d/vaccines-10-00914-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/f6c51acce380/vaccines-10-00914-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/83e370046def/vaccines-10-00914-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/150bd6a17a6d/vaccines-10-00914-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e1c/9230769/f6c51acce380/vaccines-10-00914-g003.jpg

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