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      Long term persistence of SARS-CoV-2 humoral response in Multiple Sclerosis subjects

      research-article
      Author(s): 1 , 2 , * , # , 3 , 4 , # , 3 , 1 , 1 , 2 , 1 , 2 , 5 , 6 , 7 , 2 , 2 , 1 , 1 , 1 , 1 , ǂ , 3 , * , ǂ
      Publication date (Electronic):
      Journal: Multiple Sclerosis and Related Disorders
      Publisher: Elsevier B.V.
      Keywords: BNT162b2-mRNA vaccine, coronavirus-19, disease modifying therapies, multiple sclerosis, humoral persistence, SARS-CoV-2 Spike protein, CLAD, Cladribine, COVID-19, Coronavirus disease 2019, DMF, Dimethyl fumarate, DMTs, Disease modifying therapies, EDSS, Expanded disability status scale, FTY, Fingolimod, GA, Glatiramer acetate, HC, Healthy controls, IgG, Immunoglobulin G, INF, Interferon β 1a, IQR, Interquartile range, MS, Multiple sclerosis, NAT, Natalizumab, OCRE, Ocrelizumab, PPMS, Primary progressive multiple sclerosis, RRMS, Relapsing remitting multiple sclerosis, SARS-CoV-2, severe acute respiratory syndrome coronavirus-2, SPMS, Secondary progressive multiple sclerosis, TERI, Teriflunomide

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          Abstract

          Background & Objectives

          The persistence of the severe acute respiratory syndrome coronavirus (SARS-CoV)-2 pandemic, partly due to the appearance of highly infectious variants, has made booster vaccinations necessary for vulnerable groups. Here, we present data regarding the decline of the SARS-CoV-2 BNT162b2 mRNA vaccine-induced humoral immune response in a monocentric cohort of MS patients.

          Methods

          96 MS patients undergoing eight different DMTs, all without previous SARS-CoV-2 infection, were evaluated for anti-Spike IgG levels, 21 days (T1) and 5-6 months (T2) after the second SARS-CoV-2 BNT162b2 mRNA vaccine dose. The anti-Spike IgG titres from MS subjects were compared with 21 age- and sex-matched healthy controls (HC).

          Results

          When compared with SARS-CoV-2 IgG levels at T2 in HC, we observed comparable levels in interferon-β 1a-, dimethyl fumarate-, teriflunomide- and natalizumab-treated MS subjects, but an impaired humoral response in MS subjects undergoing glatiramer acetate-, cladribine-, fingolimod- and ocrelizumab-treatments. Moreover, comparison between SARS-CoV-2 IgG Spike titre at T1 and T2 revealed a faster decline of the humoral response in patients undergoing dimethyl fumarate-, interferon-β 1a- and glatiramer acetate-therapies, while those receiving teriflunomide and natalizumab show higher persistence compared to healthy controls.

          Conclusion

          The prominent decline in humoral responses in MS subjects undergoing dimethyl fumarate-, interferon-β 1a- and glatiramer acetate-therapies should be considered when formulating booster regimens as these subjects would benefit of early booster vaccinations.

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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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            Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

            Edward E Walsh, Robert W Frenck, Ann Falsey … (2021)
            Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States. Methods In an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor–binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose. Results A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples. Conclusions The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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              Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant

              Nick Andrews, Julia Stowe, Freja Kirsebom … (2022)
              Background A rapid increase in coronavirus disease 2019 (Covid-19) cases due to the omicron (B.1.1.529) variant of severe acute respiratory syndrome coronavirus 2 in highly vaccinated populations has aroused concerns about the effectiveness of current vaccines. Methods We used a test-negative case–control design to estimate vaccine effectiveness against symptomatic disease caused by the omicron and delta (B.1.617.2) variants in England. Vaccine effectiveness was calculated after primary immunization with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine and after a booster dose of BNT162b2, ChAdOx1 nCoV-19, or mRNA-1273. Results Between November 27, 2021, and January 12, 2022, a total of 886,774 eligible persons infected with the omicron variant, 204,154 eligible persons infected with the delta variant, and 1,572,621 eligible test-negative controls were identified. At all time points investigated and for all combinations of primary course and booster vaccines, vaccine effectiveness against symptomatic disease was higher for the delta variant than for the omicron variant. No effect against the omicron variant was noted from 20 weeks after two ChAdOx1 nCoV-19 doses, whereas vaccine effectiveness after two BNT162b2 doses was 65.5% (95% confidence interval [CI], 63.9 to 67.0) at 2 to 4 weeks, dropping to 8.8% (95% CI, 7.0 to 10.5) at 25 or more weeks. Among ChAdOx1 nCoV-19 primary course recipients, vaccine effectiveness increased to 62.4% (95% CI, 61.8 to 63.0) at 2 to 4 weeks after a BNT162b2 booster before decreasing to 39.6% (95% CI, 38.0 to 41.1) at 10 or more weeks. Among BNT162b2 primary course recipients, vaccine effectiveness increased to 67.2% (95% CI, 66.5 to 67.8) at 2 to 4 weeks after a BNT162b2 booster before declining to 45.7% (95% CI, 44.7 to 46.7) at 10 or more weeks. Vaccine effectiveness after a ChAdOx1 nCoV-19 primary course increased to 70.1% (95% CI, 69.5 to 70.7) at 2 to 4 weeks after an mRNA-1273 booster and decreased to 60.9% (95% CI, 59.7 to 62.1) at 5 to 9 weeks. After a BNT162b2 primary course, the mRNA-1273 booster increased vaccine effectiveness to 73.9% (95% CI, 73.1 to 74.6) at 2 to 4 weeks; vaccine effectiveness fell to 64.4% (95% CI, 62.6 to 66.1) at 5 to 9 weeks. Conclusions Primary immunization with two doses of ChAdOx1 nCoV-19 or BNT162b2 vaccine provided limited protection against symptomatic disease caused by the omicron variant. A BNT162b2 or mRNA-1273 booster after either the ChAdOx1 nCoV-19 or BNT162b2 primary course substantially increased protection, but that protection waned over time. (Funded by the U.K. Health Security Agency.)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Mult Scler Relat Disord
                Journal ID (iso-abbrev): Mult Scler Relat Disord
                Title: Multiple Sclerosis and Related Disorders
                Publisher: Elsevier B.V.
                ISSN (Print): 2211-0348
                ISSN (Electronic): 2211-0356
                Publication date PMC-release: 12 April 2022
                Publication date (Electronic): 12 April 2022
                Electronic Location Identifier: 103800
                Affiliations
                [1 ]Neurological Clinic and Stroke Unit, "A. Cardarelli" Hospital, Via A. Cardarelli 9, 80131, Naples, Italy
                [2 ]Multiple Sclerosis Center, "A. Cardarelli" Hospital, Via A. Cardarelli 9, 80131, Naples, Italy
                [3 ]Institute of Endocrinology and Experimental Oncology (IEOS-CNR), Via S. Pansini 5, 80131, Naples, Italy
                [4 ]Department of Translational Medical Science and Center for Basic and Clinical Immunology Research (CISI), University of Naples "Federico II", Via S. Pansini 5, Naples 80131, Italy
                [5 ]Unit of Trasfusional Medicine, SIMT, "A. Cardarelli" Hospital, Via A. Cardarelli 9, 80131, Naples, Italy
                [6 ]Molecular Biology Laboratory, Hematology and Transplantation CSE; "A. Cardarelli" Hospital, Via A. Cardarelli 9, 80131, Naples, Italy
                [7 ]Clinical Pathology and Microbiology Laboratory “A. Cardarelli" Hospital, Via A. Cardarelli 9, 80131, Naples, Italy
                Author notes
                [* ]Corresponding author.
                [#]

                GTM and ALF contributed equally to this work.

                [ǂ]

                VA and VDR contributed equally as senior authors to this work.

                Article
                Publisher Item ID: S2211-0348(22)00312-1 Publisher ID: 103800
                DOI: 10.1016/j.msard.2022.103800
                PMC ID: 9005241
                SO-VID: 9c64e9c2-a7a6-4b6d-a9ac-a36cb9b1ed2d
                Copyright © © 2022 Elsevier B.V. All rights reserved.
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 9 March 2022
                Date revision received : 18 March 2022
                Date accepted : 8 April 2022
                Categories
                Subject: Article

                Keywords: bnt162b2-mrna vaccine,coronavirus-19,disease modifying therapies,multiple sclerosis,humoral persistence,sars-cov-2 spike protein,clad, cladribine,covid-19, coronavirus disease 2019,dmf, dimethyl fumarate,dmts, disease modifying therapies,edss, expanded disability status scale,fty, fingolimod,ga, glatiramer acetate,hc, healthy controls,igg, immunoglobulin g,inf, interferon β 1a,iqr, interquartile range,ms, multiple sclerosis,nat, natalizumab,ocre, ocrelizumab,ppms, primary progressive multiple sclerosis,rrms, relapsing remitting multiple sclerosis,sars-cov-2, severe acute respiratory syndrome coronavirus-2,spms, secondary progressive multiple sclerosis,teri, teriflunomide
                Data availability:
                Keywords: bnt162b2-mrna vaccine, coronavirus-19, disease modifying therapies, multiple sclerosis, humoral persistence, sars-cov-2 spike protein, clad, cladribine, covid-19, coronavirus disease 2019, dmf, dimethyl fumarate, dmts, disease modifying therapies, edss, expanded disability status scale, fty, fingolimod, ga, glatiramer acetate, hc, healthy controls, igg, immunoglobulin g, inf, interferon β 1a, iqr, interquartile range, ms, multiple sclerosis, nat, natalizumab, ocre, ocrelizumab, ppms, primary progressive multiple sclerosis, rrms, relapsing remitting multiple sclerosis, sars-cov-2, severe acute respiratory syndrome coronavirus-2, spms, secondary progressive multiple sclerosis, teri, teriflunomide

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