WHO international standard for SARS-CoV-2 antibodies to determine markers of protection

Zhu, Feng; Althaus, Thomas; Tan, Chee Wah; Costantini, Alizée; Chia, Wan Ni; Châu, Nguyễn Văn Vĩnh; Tan, Le Van; Mattiuzzo, Giada; Rose, Nicola J.; Voiglio, Eric J.; Wang, Lin‐Fa

doi:10.1016/s2666-5247(21)00307-4

Cited by 61 publications

(69 citation statements)

References 12 publications

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“…1a). We rst tested the 16-plex sVNT using the WHO international standard 20/136 31 and the neutralization activities were reduced from SARS-CoV-2 in the following descending order for the human SARS-CoV-2 variants: Delta, Alpha, Delta plus, Lambda, Gamma, Beta, Mu and Omicron. Only limited cross-reactivity to SARS-CoV-1 and clade-1 sarbecoviruses was observed (Extended Data Fig 1b).…”

Section: Resultsmentioning

confidence: 99%

Differential escape of neutralizing antibodies by SARS-CoV-2 Omicron and pre-emergent sarbecoviruses

Wang

Tan

Chia

et al. 2022

Preprint

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The SARS-CoV-2 B.1.1.529 lineage, Omicron variant, was first detected in November 2021 and carries 32 amino acid mutations in the spike protein (15 in RBD) and exhibits significant escape of neutralizing antibodies targeting the parental SARS-CoV-2 virus. Here, we performed a high-resolution multiplex (16-plex) surrogate virus neutralization assay covering all major SARS-CoV-2 variants and pre-emergent ACE2-binding sarbecoviruses against 20 different human serum panels from infected, vaccinated and hybrid immune individuals which had vaccine-breakthrough infections or infection followed by vaccination. Among all sarbecoviruses tested, we observed 1.1 to 4.7-, 2.3 to 10.3- and 0.7 to 33.3-fold reduction in neutralization activities to SARS-CoV-2 Beta, Omicron and SARS-CoV-1, respectively. Among the SARS-CoV-2 related sarbecoviruses, it is found that the genetically more distant bat RaTG13 and pangolin GX-P5L sarbecoviruses had less neutralization escape than Omicron. Our data suggest that the SARS-CoV-2 variants emerged from the changed immune landscape of human populations are more potent in escaping neutralizing antibodies, from infection or vaccination, than pre-emergent sarbecoviruses naturally evolved in animal populations with no or less immune selection pressure.

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Section: Resultsmentioning

confidence: 99%

Differential escape of neutralizing antibodies by SARS-CoV-2 Omicron and pre-emergent sarbecoviruses

Wang

Tan

Chia

et al. 2022

Preprint

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“…All samples were stored at -80 °C prior to analyses. All readouts were performed using commercially available, well-validated assays deployable in a clinical lab setting 25–29 . To avoid the bias of inter-run variation, paired (baseline-dose 1-dose 2) samples were examined on the same plate for immunoglobulin, neutralization, and cytokine assays.…”

Section: Methodsmentioning

confidence: 99%

“…Surrogate neutralization assays (cPass SARS-CoV-2 Neutralization Antibody Detection Kit, #L00847-C, GenScript Biotech Co., Nanjing City, China) were performed by assessing inhibition of the interaction between the recombinant SARS-CoV-2 receptor binding domain (RBD) fragment and the human ACE2 receptor protein (hACE2) 29 . Briefly, plasma samples and manufacturer-provided controls were pre-incubated with the horseradish peroxidase (HRP)-conjugated RBD at 37 °C for 30 min, and then added to the hACE-2 pre-coated plate for incubation at 37 °C for 15 min.…”

Section: Methodsmentioning

confidence: 99%

Sputnik-V reactogenicity and immunogenicity in the blood and mucosa: a prospective cohort study

Kadyrova

Yegorov

Negmetzhanov

et al. 2022

Preprint

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Background: Sputnik-V (Gam-COVID-Vac) is a heterologous, recombinant adenoviral (rAdv) vector-based, COVID-19 vaccine now used in >70 countries. Yet there is a shortage of data on this vaccine's performance in diverse populations. Here, we performed a prospective cohort study to assess the reactogenicity and immunologic outcomes of Sputnik-V vaccination in a multi-ethnic cohort from Kazakhstan. Methods: COVID-19-free participants (n=82 at baseline) were followed at day 21 after Sputnik-V dose 1 (rAd5) and dose 2 (rAd26). Self-reported local and systemic adverse events were captured using questionnaires. Blood and nasopharyngeal swabs were collected to perform SARS-CoV-2 diagnostic and immunologic assays. Findings: Of the 73 and 70 participants retained post-dose 1 and 2, respectively, most (>50%) reported mild-to-moderate injection site or systemic reactions to vaccination; no severe or potentially life-threatening conditions were reported. dose 1 appeared to be more reactogenic than dose 2, with fatigue and headache more frequent in participants with prior COVID-19 exposure. After dose 2 nausea was more common in subjects without prior COVID-19. The combined S-IgG and S-IgA seroconversion rate was 97% post-dose 1, remaining the same post-dose 2. The proportion of participants with detectable virus neutralization titers was 83% post-dose 1', and increased to 98% post-dose 2', with the largest relative increase observed in participants without prior COVID-19 exposure. Nasal S-IgG and S-IgA increased post-dose 1, while the boosting effect of dose 2 on mucosal S-IgG, but not S-IgA, was only observed in subjects without prior COVID-19. Systemically, vaccination reduced serum levels of growth regulated oncogene (GRO), which correlated with an elevation in blood platelet count. Interpretation: Sputnik-V dose 1 elicited both blood and mucosal SARS-CoV-2 immunity, while the immune boosting effect of dose 2 was minimal, suggesting that adjustments to the current vaccine dosing regimen may be necessary to optimize immunization efficacy and cost-effectiveness. Although Sputnik-V appears to have a reactogenicity profile similar to that of other COVID-19 vaccines, the observed alterations to the GRO/platelet axis call for further investigation of Sputnik V effects on systemic immunology. Funding: Ministry of Education and Science of the Republic of Kazakhstan.

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“…One approach would be to standardize the method for assessing neutralizing activity [49]. Another approach is to use an external standard, such as that provided by the World Health Organization (WHO) to calibrate the results of assays performed under different conditions [49,59]. However, this reagent's limited and non-renewable nature currently limits its widescale utilization [60].…”

Section: Discussionmentioning

confidence: 99%

Susceptibility of SARS-CoV-2 Omicron Variants to Therapeutic Monoclonal Antibodies: Systematic Review and Meta-Analysis

Tao¹,

Tzou²,

Pond³

et al. 2022

Preprint

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SARS-CoV-2 Omicron variants contain many mutations in its spike receptor binding domain, the target of all authorized monoclonal antibodies (mAbs). Determining the extent to which Omicron variants reduced mAb susceptibility is critical to preventing and treating COVID-19. We systematically reviewed PubMed and three preprint servers, last updated February 22, 2022, of the in vitro activity of authorized mAbs against the Omicron variants. Thirty-three studies were eligible including 33 containing Omicron BA.1 susceptibility data and five that also contained Omicron BA.2 susceptibility data. The first two authorized mAb combinations, bamlanivimab/etesevimab and casirivimab/imdevimab, were inactive against the Omicron BA.1 and BA.2 variants. In 24 studies, sotrovimab (third authorized mAb) displayed a median 4.1-fold (IQR: 2.4-7.6) reduced activity against Omicron BA.1 and, in four studies, a median 26-fold (IQR:16-35) reduced activity against Omicron BA.2. In 18 studies, cilgavimab and tixagevimab independently displayed median reductions in activity of >300-fold against Omicron BA.1, while in ten studies, the cilgavimab/tixagevimab combination (fourth authorized mAb preparation) displayed a median 63-fold (IQR: 26-145) reduced activity against Omicron BA.1. In two studies, cilgavimab was approximately 100-fold more susceptible to BA.2 than to BA.1. In two studies, bebtelovimab, the most recently authorized mAb, was fully active against both the Omicron variants. Disparate results between assays were common as evidenced by a median 42-fold range (IQR: 25-625) in IC50 between assays for the eight authorized individual mAbs and three authorized mAb combinations. Highly disparate results between published assays indicates a need for improved mAb susceptibility test standardization or inter-assay calibration.

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WHO international standard for SARS-CoV-2 antibodies to determine markers of protection

Cited by 61 publications

References 12 publications

Differential escape of neutralizing antibodies by SARS-CoV-2 Omicron and pre-emergent sarbecoviruses

Differential escape of neutralizing antibodies by SARS-CoV-2 Omicron and pre-emergent sarbecoviruses

Sputnik-V reactogenicity and immunogenicity in the blood and mucosa: a prospective cohort study

Susceptibility of SARS-CoV-2 Omicron Variants to Therapeutic Monoclonal Antibodies: Systematic Review and Meta-Analysis

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