Correlation of the Commercial Anti-SARS-CoV-2 Receptor Binding Domain Antibody Test with the Chemiluminescent Reduction Neutralizing Test and Possible Detection of Antibodies to Emerging Variants DOI Creative Commons

Yoshitomo Morinaga,

Hideki Tani,

Yasushi Terasaki

et al.

Microbiology Spectrum, Journal Year: 2021, Volume and Issue: 9(3)

Published: Dec. 1, 2021

Serological tests are beneficial for recognizing the immune response against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). To identify protective immunity, optimization of chemiluminescent reduction neutralizing test (CRNT) is critical. Whether commercial antibody have comparable accuracy unknown. Serum samples were obtained from COVID-19 patients (n = 74), SARS-CoV-2 PCR-negative 179), and suspected healthy individuals 229) before variants had been detected locally. The convalescent phase was defined as period after day 10 disease onset or episode close contact. CRNT using pseudotyped viruses displaying wild-type (WT) spike protein a anti-receptor-binding domain (RBD) assayed. Serology B.1.1.7 B.1.351 also Both concurred symptomatic in phase. They clearly differentiated between (sensitivity: 95.8% 100%, respectively; specificity: 99.1% respectively). Anti-RBD results correlated with titers (r 0.31, 95% confidence interval [CI] 0.22-0.38). Compared WT, lower values observed variants. Of ≥100 U/mL by anti-RBD test, 77.8% 88.9% showed ≥50% neutralization variants, respectively. Exceeding 100 associated (P < 0.01). effectively classified patients. Strong positive can reflect activity emerging IMPORTANCE This study provides diagnostic evidence validity, which lead to vaccine efficacy proof recovery COVID-19. It not easy know clinical laboratory because technical biohazard issues. correlation quantitative widely available, indicates that we indirectly state acquisition functional immunity wild variant-type laboratory.

Language: Английский

Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies DOI Creative Commons
Maria Pia Sormani, Matilde Inglese, Irene Schiavetti

et al.

EBioMedicine, Journal Year: 2021, Volume and Issue: 72, P. 103581 - 103581

Published: Sept. 22, 2021

In patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) affects immune response to antigens. Therefore, post-vaccination serological assessments are needed evaluate the effect of vaccine on SARS-CoV-2 antibody response.We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination mRNA vaccines (BNT162b2, Pfizer/BioNTech,Inc or mRNA-1273, Moderna Tx,Inc). A blood collection before first dose and 4 weeks after second was planned, centralized assessment (electrochemiluminescence immunoassay, ECLIA, Roche-Diagnostics). The log-transform levels analyzed by multivariable linear regression.780 (76% BNT162b2 24% mRNA-1273) had pre- 4-week assessments. 87 (11·2%) untreated, 154 (19·7%) ocrelizumab, 25 (3·2%) rituximab, 85 (10·9%) fingolimod, cladribine 404 (51·7%) other DMTs. 677 (86·8%) detectable antibodies. At analysis, ocrelizumab (201-fold decrease (95%CI=128-317), p < 0·001), fingolimod (26-fold (95%CI=16-42), 0·001) rituximab (20-fold (95%CI=10-43), significantly reduced as compared untreated patients. Vaccination mRNA-1273 resulted in systematically 3·25-fold higher level (95%CI=2·46-4·27) than (p 0·001). anti-CD20 correlated time since last infusion, longer intervals (mean=386 days) (mean=129 days).In pwMS, treatment led humoral mRNA-based vaccines. As elicits 3·25-higher BNT162b2, this may be preferentially considered under fingolimod. Combining our data those cellular vaccines, including clinical follow-up, will contribute better define most appropriate strategies context DMTs MS.FISM[2021/Special-Multi/001]; Italian Ministry Health'Progetto Z844A 5 × 1000'.

Language: Английский

Citations

213
SARS-CoV2-specific Humoral and T-cell Immune Response After Second Vaccination in Liver Cirrhosis and Transplant Patients DOI Open Access
Darius F. Ruether,

Golda Schaub,

Paul Duengelhoef

et al.

Clinical Gastroenterology and Hepatology, Journal Year: 2021, Volume and Issue: 20(1), P. 162 - 172.e9

Published: Sept. 9, 2021

Language: Английский

Citations

133
Antibody responses to BNT162b2 mRNA COVID-19 vaccine and their predictors among healthcare workers in a tertiary referral hospital in Japan DOI Creative Commons
Takahiro Kageyama, Kei Ikeda, Shigeru Tanaka

et al.

Clinical Microbiology and Infection, Journal Year: 2021, Volume and Issue: 27(12), P. 1861.e1 - 1861.e5

Published: Aug. 8, 2021

Language: Английский

Citations

127
Waning of IgG, Total and Neutralizing Antibodies 6 Months Post-Vaccination with BNT162b2 in Healthcare Workers DOI Creative Commons
Jean‐Louis Bayart, Jonathan Douxfils, Constant Gillot

et al.

Vaccines, Journal Year: 2021, Volume and Issue: 9(10), P. 1092 - 1092

Published: Sept. 28, 2021

Data about the long-term duration of antibodies after SARS-CoV-2 vaccination are still scarce and important to design strategies. In this study, 231 healthcare professionals received two-dose regimen BNT162b2. Of these, 158 were seronegative 73 seropositive at baseline. Samples collected several time points. The neutralizing (NAbs) against nucleocapsid spike protein measured. At day 180, a significant antibody decline was observed in (-55.4% with total assay; -89.6% IgG assay) individuals (-74.8% -79.4% assay). estimated half-life from peak humoral response 21 days (95% CI: 13-65) 53 40-79) individuals. longer ranged 68 54-90) 114 87-167) individuals, respectively. NAbs more pronounced (-98.6%) around 45% subjects tested negative 180. Whether decrease correlates an equivalent drop clinical effectiveness virus would require appropriate studies.

Language: Английский

Citations

114
Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay DOI Creative Commons

Elena Riester,

Peter Findeisen,

Johannes Kolja Hegel

et al.

Journal of Virological Methods, Journal Year: 2021, Volume and Issue: 297, P. 114271 - 114271

Published: Aug. 27, 2021

The Elecsys® Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated assay performance using samples from seven sites in Germany, Austria, and Switzerland. For specificity sensitivity analyses, 7880 presumed negative pre-pandemic 827 SARS-CoV-2 PCR-confirmed single or sequential 272 different patients were tested, respectively. overall (≥14 days post-PCR) Elecsys 99.95% (95% confidence interval [CI]: 99.87-99.99; 7876/7880) 97.92% CI: 95.21-99.32; 235/240), had significantly higher compared with LIAISON® S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/2033]), ADVIA Centaur® Total (100% [928/928] 86.96% [807/928]), ARCHITECT (99.97% [2931/2932] 99.69% [2923/2932]), iFlash-SARS-CoV-2 IgM (100.00% 99.57% [924/928]), EUROIMMUN [903/903] 97.45% [880/903]) IgA [895/895] 95.75% [857/895]) assays. (98.70% [76/77] 87.01% [67/77]), [76/76] 93.42% [71/76]) 35.53% [27/76]), (98.26% [113/115] 93.91% [108/115]) Therefore, demonstrated a reliable across various sample populations anti-S antibodies.

Language: Английский

Citations

108
Anti-spike antibody response to SARS-CoV-2 booster vaccination in patients with B cell-derived hematologic malignancies DOI Creative Commons
Lee M. Greenberger, Larry A. Saltzman, Jonathon W. Senefeld

et al.

Cancer Cell, Journal Year: 2021, Volume and Issue: 39(10), P. 1297 - 1299

Published: Sept. 7, 2021

Language: Английский

Citations

94
Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in persons with HIV DOI Open Access
Jake A. Ruddy, Brian J. Boyarsky, Justin R. Bailey

et al.

AIDS, Journal Year: 2021, Volume and Issue: 35(14), P. 2399 - 2401

Published: July 8, 2021

This study of SARS-CoV-2 mRNA vaccination in 14 persons with HIV (PWH) demonstrated uniformly high anti-SARS-CoV-2 receptor binding domain (RBD) antibody titres after two doses, despite varied a single dose. The majority vaccine reactions were mild and no adverse events occurred.

Language: Английский

Citations

72
Humoral immune response to COVID‐19 vaccination in diabetes is age‐dependent but independent of type of diabetes and glycaemic control: The prospective COVAC‐DM cohort study DOI Creative Commons
Caren Sourij, Norbert J. Tripolt, Faisal Aziz

et al.

Diabetes Obesity and Metabolism, Journal Year: 2022, Volume and Issue: 24(5), P. 849 - 858

Published: Jan. 5, 2022

Abstract Aims To investigate the seroconversion following first and second COVID‐19 vaccination in people with type 1 2 diabetes relation to glycaemic control prior analyse response comparison individuals without diabetes. Materials methods This prospective, multicentre cohort study analysed a glycated haemoglobin level ≤58 mmol/mol (7.5%) or >58 (7.5%), respectively, healthy controls. Roche's Elecsys anti‐SARS‐CoV‐2 S immunoassay targeting receptor‐binding domain was used quantify anti‐spike protein antibodies 7 14 days after 21 vaccination. Results A total of 86 controls were enrolled study, as well 161 participants diabetes, whom 150 (75 75 diabetes) eligible for analysis. After vaccination, only 52.7% group 48.0% those showed antibody levels above cut‐off positivity. Antibody similar adjusting age, sex multiple testing ( P > 0.05). Age r = −0.45, < 0.001) glomerular filtration rate 0.28, significantly associated response. Conclusions Anti‐SARS‐CoV‐2 comparable irrespective control. renal function correlated extent levels.

Language: Английский

Citations

54
Anti-SARS-CoV-2 mRNA vaccine in patients with rheumatoid arthritis DOI Creative Commons
Andrea Rubbert‐Roth,

Nicolas Vuilleumier,

Burkhard Ludewig

et al.

The Lancet Rheumatology, Journal Year: 2021, Volume and Issue: 3(7), P. e470 - e472

Published: June 8, 2021

Long-term vaccine-induced immunity is crucial for controlling the COVID-19 pandemic. Vaccination against recommended patients with rheumatic diseases, but a paucity of data are available regarding vaccines in rheumatoid arthritis. Because receiving immunosuppressive treatment were excluded from phase 3 clinical trials,1Polack FP Thomas SJ Kitchin N et al.Safety and efficacy BNT162b2 mRNA vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (9627) Google Scholar, 2Walsh EE Frenck Jr, RW Falsey AR immunogenicity two RNA-based vaccine candidates.N 2439-2450Crossref (1752) Scholar it not clear whether disease-modifying anti-rheumatic drug (DMARD) should be continued before after vaccination. In addition, some published reports limited to follow-up single dose.3Boyarsky BJ Ruddy JA Connolly CM al.Antibody response dose SARS-CoV-2 musculoskeletal diseases.Ann Rheum Dis. 2021; (published online March 23.)https://doi.org/10.1136/annrheumdis-2021-220289Crossref (148) 4Geisen UM Berner DK Tran F al.Immunogenicity safety anti-SARS-CoV-2 chronic inflammatory conditions therapy monocentric cohort.Ann 24.)https://doi.org/10.1136/annrheumdis-2021-220272Crossref (280) 5Sadoff Gray G Vandebosch A single-dose Ad26.COV2.S COVID-19.N April 21.)https://doi.org/10.1056/NEJMoa2101544Crossref (1609) Here we report 53 consecutive arthritis on DMARDs 20 healthy controls (appendix p 1) who eligible vaccination according Swiss federal regulations enrolled RECOVER study, non-randomised, prospective, observational trial. The study was approved by Ethical Committee St Gallen, Switzerland, written consent obtained all inclusion. itself part study. Nine received doses mRNA-1273 (Moderna), others (Pfizer–BioNTech). Serum samples collected at baseline, weeks first vaccination, 2 second Quantitative antibody testing done using Roche Elecsys Anti-SARS-CoV-2 spike subunit 1 (S1) assay that measures antibodies protein (range 0·4–2500 U/mL) nucleoprotein. This used because can distinguish between people develop an anti-S1 or natural infection, when typically both S1 nucleoprotein generated. threshold this might correspond neutralisation viral infectivity still being discussed, cutoff level 133 U/mL has been proposed.6Resman Rus K Korva M Knap Avšič Županc T Poljak Performance rapid high-throughput automated electrochemiluminescence immunoassay targeting total receptor binding domain comparison neutralization assay.J Clin Virol. 139104820Crossref (85) lower >15 suggested,7Rubio-Acero R Castelletti Fingerle V al.In search protection correlate: head-to-head quantitative assays group pre-characterized oligo-/asymptomatic patients.medRxiv. Feb 23.) (preprint)https://www.medrxiv.org/content/10.1101/2021.02.19.21252080v1Google emphasising need establish formal levels titres associated infection severe disease. Intervals intervals serum sampling comparable 1). All continuous conventional synthetic, biological, targeted synthetic DMARDs. Methotrexate 28 (53%) median 15 mg per day (IQR 10–20). 17 (32%) low prednisone mean daily 5 (SD 1·9 mg). None reported symptoms suggestive baseline during observation period, none had positive antigen RT-PCR test. Two consistent previously unnoticed COVID-19, these further analysis. Vaccine-induced significantly (median 0·4 U/mL, IQR 0·4–2·13) (657 188–2500) than control group, which mainly consisted health-care workers (3 vaccination: 99·2 24·8–172; 2500 2500–2500 (upper limit detection U/mL); p<0·0001; figure). 18 (90%) reached titre above whereas only five (10%) 51 did (p<0·001). (45%) higher their compared (2%) Six (12%) have more dose, four JAK inhibitor monotheray combination therapy, one patient methotrexate abatacept 2). (18%) less developed high (ceiling U/mL). 13 (81%) 16 csDMARDs, (94%) anti-cytokine directed biologics monotherapy 2), (80%) abatacept, eight (67%) 12 inhibitors humoral immune line neutralising capacity (ie, dose. Anti-S1 differ age, sex, disease duration, use low-dose prednisone. These suggest kinetics differs taking individuals. Significantly required mount considered correlate neutralisation, cutoffs analysed. countries, delayed administration discussed increase number least dose.8Joint ImmunisationOptimising programme maximum short-term impact.https://www.gov.uk/government/publications/prioritising-the-first-covid-19-vaccine-dose-jcvi-statement/optimising-the-covid-19-vaccination-programme-for-maximum-short-term-impactDate: Jan 26, 2021Date accessed: January 29, 2021Google Our implies successful depend schedule includes vaccinations within interval 3–6 weeks. Limitations our include age-matched, as result regulatory recommendations long-term persistence cellular responses, numerical possible correlates protection. shows different protein, importance Studies large cohorts longer duration define optimal strategy arthritis, clarify paused monitoring concentrations ensure AR-R consulting fees AbbVie, Gilead, Lilly, BMS, Sanofi, honoraria Pfizer, UCB, Roche, payment expert testimony AbbVie support travel meeting attendance compensation participation Data Safety Monitoring Board R-Pharm. KS Deutschland. JvK Eli Pfizer. other authors declare no competing interests. access accessed verified trial registered Business Administration System Ethics Committees (number2021-00156). Download .pdf (.07 MB) Help pdf files Supplementary appendix Pausing drugs spacing vaccines: open question – Authors' replyWe thank Mia Rodziewicz colleagues interest Comment1 mRNA-based discussion doses. Most (44 [83%] 53) (Pfizer–BioNTech) nine (17%) (Moderna); regulations, based proposed manufacturers. Full-Text PDF questionWe read Article Andrea Rubbert-Roth colleagues,1 among various (DMARDs), responses reduced controls.

Language: Английский

Citations

50
Effect of Different Disease-Modifying Therapies on Humoral Response to BNT162b2 Vaccine in Sardinian Multiple Sclerosis Patients DOI Creative Commons
Maristella Pitzalis, Maria Laura Idda, Valeria Lodde

et al.

Frontiers in Immunology, Journal Year: 2021, Volume and Issue: 12

Published: Dec. 9, 2021

Objectives Vaccination against COVID-19 is highly recommended to patients affected by multiple sclerosis (MS); however, the impact of MS disease-modifying therapies (DMTs) on immune response following vaccination has been only partially investigated. Here, we aimed elucidate effect DMTs humoral mRNA-based anti-SARS-CoV-2 vaccines in patients. Methods We obtained sera from 912 Sardinian and 63 healthy controls 30 days after second dose BNT162b2 vaccine tested them for SARS-CoV-2 using anti-Spike (S) protein-based serology. Previous infection was assessed anti-Nucleocapsid (N) Patients were either untreated or undergoing treatment with a total 13 different DMTs. Differences between groups comprised at least 10 generalized linear mixed-effects model. Demographic clinical data smoking status analyzed as additional factors potentially influencing immunity vaccine. Results treated natalizumab, teriflunomide, azathioprine, fingolimod, ocrelizumab, rituximab showed significantly lower responses compared did not observe statistically significant difference other drugs (dimethyl fumarate, interferon, alemtuzumab glatiramer acetate) In addition, older age, male sex active associated antibody titers SARS-CoV-2. previously infected had higher than uninfected Conclusion Humoral influenced specific followed patients, well such previous infection, sex, status. These results are important inform targeted strategies prevent clinically relevant

Language: Английский

Citations

50