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一种新冠疫苗接种方案的免疫原性和不良事件的初步研究:先用灭活全新冠病毒疫苗(科兴新冠疫苗)进行 priming,再用腺病毒载体(ChAdOx1 nCoV-19)疫苗进行加强免疫。 (注:这里“priming”暂未找到非常准确的对应中文术语,可根据具体语境灵活理解为某种前期接种方式等)

The Pilot Study of Immunogenicity and Adverse Events of a COVID-19 Vaccine Regimen: Priming with Inactivated Whole SARS-CoV-2 Vaccine (CoronaVac) and Boosting with the Adenoviral Vector (ChAdOx1 nCoV-19) Vaccine.

作者信息

Mahasirimongkol Surakameth, Khunphon Athiwat, Kwangsukstid Oraya, Sapsutthipas Sompong, Wichaidit Mingkwan, Rojanawiwat Archawin, Wichuckchinda Nuanjun, Puangtubtim Wiroj, Pimpapai Warangluk, Soonthorncharttrawat Sakulrat, Wanitchang Asawin, Jongkaewwattana Anan, Srisutthisamphan Kanjana, Phainupong Daraka, Thawong Naphatcha, Piboonsiri Pundharika, Sawaengdee Waritta, Somsaard Thitiporn, Ritthitham Kanokphon, Chumpol Supaporn, Pinyosukhee Nadthanan, Wichajarn Rattanawadee, Dhepakson Panadda, Iamsirithaworn Sopon, Phumiamorn Supaporn

机构信息

Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand.

Institute of Dermatology, Department of Medical Services, Ministry of Public Health, Bangkok 10400, Thailand.

出版信息

Vaccines (Basel). 2022 Mar 30;10(4):536. doi: 10.3390/vaccines10040536.

DOI:10.3390/vaccines10040536
PMID:35455285
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9028748/
Abstract

In response to the SARS-CoV-2 Delta variant, which partially escaped the vaccine-induced immunity provided by two doses of vaccination with CoronaVac (Sinovac), the National Vaccine Committee recommended the heterologous CoronaVac-ChAdOx1 (Oxford−AstraZeneca), a prime−boost vaccine regimen. This pilot study aimed to describe the immunogenicity and adverse events of the heterologous CoronaVac-ChAdOx1 regimen, in comparison with homologous CoronaVac, and homologous ChAdOx1. Between May and August 2021, we recruited a total of 354 participants from four vaccination groups: the CoronaVac-ChAdOx1 vaccinee (n = 155), the homologous CoronaVac vaccinee (n = 32), the homologous ChAdOx1 vaccinee (n = 47), and control group of COVID-19 patients (n = 120). Immunogenicity was evaluated by measuring the level of IgG antibodies against the receptor-binding domain (anti-SRBD) of the SARS-CoV-2 spike protein S1 subunit and the level of neutralizing antibodies (NAbs) against variants of concern (VOCs) using the plaque reduction neutralization test (PRNT) and pseudovirus neutralization test (pVNT). The safety profile was recorded by interviewing at the 1-month visit after vaccination. The anti-SRBD level after the second booster dose of the CoronaVac-ChAdOx1 group at 2 weeks was higher than 4 weeks. At 4 weeks after the second booster dose, the anti-SRBD level in the CoronaVac-ChAdOx1 group was significantly higher than either homologous CoronaVac, the homologous ChAdOx1 group, and Control group (p < 0.001). In the CoronaVac-ChAdOx1 group, the PRNT50 level against the wild-type (434.5 BAU/mL) was the highest; followed by Alpha variant (80.4), Delta variant (67.4), and Beta variant (19.8). The PVNT50 level was also found to be at its highest against the wild-type (432.1); followed by Delta variants (178.3), Alpha variants (163.9), and Beta variant (42.2), respectively. The AEs in the CoronaVac-ChAdOx1 group were well tolerated and generally unremarkable. The CoronaVac-ChAdOx1 heterologous regimen induced higher immunogenicity and a tolerable safety profile. In a situation when only CoronaVac-ChAdOx1 vaccines are available, they should be considered for use in responding to the Delta variant.

摘要

为应对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)德尔塔变异株,该变异株部分逃避了两剂科兴新冠疫苗(CoronaVac,Sinovac)诱导的疫苗免疫,国家疫苗委员会推荐了异源的科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗(ChAdOx1)的初免-加强疫苗接种方案。这项前瞻性研究旨在描述异源科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗接种方案的免疫原性和不良事件,并与同源科兴新冠疫苗和同源牛津-阿斯利康腺病毒载体疫苗进行比较。2021年5月至8月,我们从四个接种组共招募了354名参与者:科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗接种者(n = 155)、同源科兴新冠疫苗接种者(n = 32)、同源牛津-阿斯利康腺病毒载体疫苗接种者(n = 47)以及新冠病毒病患者对照组(n = 120)。通过使用蚀斑减少中和试验(PRNT)和假病毒中和试验(pVNT)测量针对SARS-CoV-2刺突蛋白S1亚基受体结合域的IgG抗体水平(抗SRBD)以及针对关注变异株(VOC)的中和抗体(NAb)水平来评估免疫原性。通过在接种后1个月随访时进行访谈来记录安全性。科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗组在第二次加强剂量后2周的抗SRBD水平高于4周时。在第二次加强剂量后4周,科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗组的抗SRBD水平显著高于同源科兴新冠疫苗组、同源牛津-阿斯利康腺病毒载体疫苗组和对照组(p < 0.001)。在科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗组中,针对野生型的PRNT50水平最高(434.5 BAU/mL);其次是阿尔法变异株(80.4)、德尔塔变异株(67.4)和贝塔变异株(19.8)。还发现针对野生型的PVNT50水平最高(432.1);其次分别是德尔塔变异株(178.3)、阿尔法变异株(163.9)和贝塔变异株(42.2)。科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗组的不良事件耐受性良好,总体无显著异常。科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗异源接种方案诱导了更高的免疫原性和可耐受的安全性。在仅可获得科兴新冠疫苗-牛津-阿斯利康腺病毒载体疫苗的情况下,应考虑使用它们来应对德尔塔变异株。

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8
Effectiveness of an Inactivated SARS-CoV-2 Vaccine.一种灭活新型冠状病毒疫苗的有效性
N Engl J Med. 2021 Sep 2;385(10):946-948. doi: 10.1056/NEJMe2111165.
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Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial.腺病毒载体新冠疫苗和 mRNA 新冠疫苗序贯和同源加强接种的安全性和免疫原性比较(Com-COV):一项单盲、随机、非劣效性试验。
Lancet. 2021 Sep 4;398(10303):856-869. doi: 10.1016/S0140-6736(21)01694-9. Epub 2021 Aug 6.
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Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant.Covid-19 疫苗对 B.1.617.2(德尔塔)变异株的有效性。
N Engl J Med. 2021 Aug 12;385(7):585-594. doi: 10.1056/NEJMoa2108891. Epub 2021 Jul 21.