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      The significant immune escape of pseudotyped SARS-CoV-2 variant Omicron

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          ABSTRACT

          The emergence of Omicron/BA.1 has brought new challenges to fight against SARS-CoV-2. A large number of mutations in the Spike protein suggest that its susceptibility to immune protection elicited by the existing COVID-19 infection and vaccines may be altered. In this study, we constructed the pseudotyped SARS-CoV-2 variant Omicron. The sensitivity of 28 serum samples from COVID-19 convalescent patients infected with SARS-CoV-2 original strain was tested against pseudotyped Omicron as well as the other variants of concern (VOCs, Alpha, Beta, Gamma, Delta) and variants of interest (VOIs, Lambda, Mu). Our results indicated that the mean neutralization ED50 of these sera against Omicron decreased to 66, which is about 8.4-folds compared to the D614G reference strain (ED50 = 556), whereas the neutralization activity of other VOC and VOI pseudotyped viruses decreased only about 1.2–4.5-folds. The finding from our in vitro assay suggest that Omicron variant may lead to more significant escape from immune protection elicited by previous SARS-CoV-2 infection and perhaps even by existing COVID-19 vaccines.

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          Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

          David Khoury, Deborah Cromer, Arnold Reynaldi … (2021)
          Predictive models of immune protection from COVID-19 are urgently needed to identify correlates of protection to assist in the future deployment of vaccines. To address this, we analyzed the relationship between in vitro neutralization levels and the observed protection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using data from seven current vaccines and from convalescent cohorts. We estimated the neutralization level for 50% protection against detectable SARS-CoV-2 infection to be 20.2% of the mean convalescent level (95% confidence interval (CI) = 14.4-28.4%). The estimated neutralization level required for 50% protection from severe infection was significantly lower (3% of the mean convalescent level; 95% CI = 0.7-13%, P = 0.0004). Modeling of the decay of the neutralization titer over the first 250 d after immunization predicts that a significant loss in protection from SARS-CoV-2 infection will occur, although protection from severe disease should be largely retained. Neutralization titers against some SARS-CoV-2 variants of concern are reduced compared with the vaccine strain, and our model predicts the relationship between neutralization and efficacy against viral variants. Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic.
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            A human neutralizing antibody targets the receptor binding site of SARS-CoV-2

            Rui Shi, Chao Shan, Xiaomin Duan … (2020)
            An outbreak of coronavirus disease 2019 (COVID-19)1-3, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)4, has spread globally. Countermeasures are needed to treat and prevent further dissemination of the virus. Here we report the isolation of two specific human monoclonal antibodies (termed CA1 and CB6) from a patient convalescing from COVID-19. CA1 and CB6 demonstrated potent SARS-CoV-2-specific neutralization activity in vitro. In addition, CB6 inhibited infection with SARS-CoV-2 in rhesus monkeys in both prophylactic and treatment settings. We also performed structural studies, which revealed that CB6 recognizes an epitope that overlaps with angiotensin-converting enzyme 2 (ACE2)-binding sites in the SARS-CoV-2 receptor-binding domain, and thereby interferes with virus-receptor interactions by both steric hindrance and direct competition for interface residues. Our results suggest that CB6 deserves further study as a candidate for translation to the clinic.
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              Establishment and validation of a pseudovirus neutralization assay for SARS-CoV-2

              Jianhui Nie, Qianqian Li, Jiajing Wu … (2020)
              ABSTRACT Pseudoviruses are useful virological tools because of their safety and versatility, especially for emerging and re-emerging viruses. Due to its high pathogenicity and infectivity and the lack of effective vaccines and therapeutics, live SARS-CoV-2 has to be handled under biosafety level 3 conditions, which has hindered the development of vaccines and therapeutics. Based on a VSV pseudovirus production system, a pseudovirus-based neutralization assay has been developed for evaluating neutralizing antibodies against SARS-CoV-2 in biosafety level 2 facilities. The key parameters for this assay were optimized, including cell types, cell numbers, virus inoculum. When tested against the SARS-CoV-2 pseudovirus, SARS-CoV-2 convalescent patient sera showed high neutralizing potency, which underscore its potential as therapeutics. The limit of detection for this assay was determined as 22.1 and 43.2 for human and mouse serum samples respectively using a panel of 120 negative samples. The cutoff values were set as 30 and 50 for human and mouse serum samples, respectively. This assay showed relatively low coefficient of variations with 15.9% and 16.2% for the intra- and inter-assay analyses respectively. Taken together, we established a robust pseudovirus-based neutralization assay for SARS-CoV-2 and are glad to share pseudoviruses and related protocols with the developers of vaccines or therapeutics to fight against this lethal virus.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Emerg Microbes Infect
                Journal ID (iso-abbrev): Emerg Microbes Infect
                Title: Emerging Microbes & Infections
                Publisher: Taylor & Francis
                ISSN (Electronic): 2222-1751
                Publication date (Electronic, pub): 21 December 2021
                Publication date (Electronic, collection): 2022
                Publication date PMC-release: 21 December 2021
                Volume: 11
                Issue: 1
                Pages: 1-5
                Affiliations
                [a ]Division of HIV/AIDS and Sex-transmitted Virus Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control (NIFDC) , Beijing, People’s Republic of China
                [b ]Jiangsu Recbio Technology Co., Ltd. , Taizhou, People’s Republic of China
                [c ]Graduate School of Peking Union Medical College , Beijing, People’s Republic of China
                [d ]Translational Medicine Institute, The First People’s Hospital of Chenzhou, University of South China , Chenzhou, People’s Republic of China
                Author notes
                [CONTACT ] Youchun Wang wangyc@ 123456nifdc.org.cn Division of HIV/AIDS and Sex-transmitted Virus Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control (NIFDC) , No. 31 Huatuo Street, Daxing District, Beijing 102629, People’s Republic of China
                Xiaowang Qu quxiaowang@ 123456163.com Translational Medicine Institute, The First People’s Hospital of Chenzhou, University of South China , Chenzhou 423000, People’s Republic of China
                Weijin Huang huangweijin@ 123456nifdc.org.cn Division of HIV/AIDS and Sex-transmitted Virus Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control (NIFDC) , Beijing, People’s Republic of China
                [*]

                Lead contact

                [†]

                These authors contributed equally to this work.

                Supplemental data for this article can be accessed at https://doi.org/10.1080/22221751.2021.2017757

                Author information
                https://orcid.org/0000-0001-9769-5141
                Article
                Publisher ID: 2017757
                DOI: 10.1080/22221751.2021.2017757
                PMC ID: 8725892
                PubMed ID: 34890524
                SO-VID: 29f74df0-dbef-43e9-ba68-28adb7933310
                Copyright © © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group, on behalf of Shanghai Shangyixun Cultural Communication Co., Ltd
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Page count
                Figures: 1, Tables: 0, Equations: 0, References: 12, Pages: 5
                Categories
                Subject: Coronaviruses
                Subject: Research Article

                Keywords: sars-cov-2,ba.1,neutralization,convalescence serum,voc
                Data availability:
                Keywords: sars-cov-2, ba.1, neutralization, convalescence serum, voc

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