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• W3187336349 abstract "On March 11, 2020, the World Health Organization declared that the coronavirus disease 2019 (COVID-19) was a pandemic.1Polack FP Thomas SJ Kitchin N et al.Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (8459) Google Scholar Since then, the disease has reached a 1% to 3% estimated overall mortality rate.2Wu Z McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention.JAMA. 2020; 323: 1239-1242Crossref PubMed Scopus (11886) Google Scholar COVID-19 severity ranges from asymptomatic to acute respiratory distress syndrome and possible death owing to multiorgan failure.2Wu Z McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention.JAMA. 2020; 323: 1239-1242Crossref PubMed Scopus (11886) Google Scholar Therefore, to ameliorate the resultant poor health and social and economic consequences, prophylactic vaccines were developed. On December 11, 2020, the US Food and Drug Administration issued the first emergency use authorization of Pfizer-BioNTech (Pfizer Inc, New York City, New York) messenger RNA (mRNA) vaccine (BNT162b2) for COVID-19 prevention.1Polack FP Thomas SJ Kitchin N et al.Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (8459) Google Scholar The vaccine was approved after a large randomized, placebo-controlled trial in approximately 44,000 participants aged 16 years or older and revealed that a 2-dose regimen of BNT162b2 conferred 95% protection against symptomatic COVID-19.1Polack FP Thomas SJ Kitchin N et al.Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (8459) Google Scholar This novel lipid nanoparticle-formulated nucleoside-modified RNA vaccine encodes the full-length spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which contains the receptor binding domain (RBD) within the S1 subunit.3Mulligan MJ Lyke KE Kitchin N et al.Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.Nature. 2020; 586: 589-593Crossref PubMed Scopus (963) Google Scholar The RBD is a key functional component within the S1 subunit responsible for binding SARS-CoV-2 to angiotensin-converting enzyme 2 receptor, a critical initial step enabling SARS-CoV-2 to penetrate target cells.4Walls AC Park YJ Tortorici MA Wall A McGuire AT Veesler D. Structure, function, and antigenicity of the SARS-CoV-2 spike glycoprotein.Cell. 2020; 181 (e6): 281-292Abstract Full Text Full Text PDF PubMed Scopus (5486) Google Scholar Among healthy adults, two 30 µg doses of BNT162b2 elicited robust antigen-specific CD8+ and TH1-type CD4+ T-cell responses and strong specific antibody responses directed against RBD.5Sahin U Muik A Derhovanessian E et al.COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses.Nature. 2020; 586: 594-599Crossref PubMed Scopus (1159) Google Scholar Nevertheless, it is unknown whether patients having primary immunodeficiency disorders of humoral immunity affecting B-cell differentiation and antibody production are able to produce effective specific antibody levels after the 2-dose BNT162b2 regimen. Common variable immunodeficiency (CVID) is an antibody deficiency with variable clinical manifestations; although patients mostly experience recurrent infections, there is an increased prevalence of autoimmune diseases and malignancy secondary to immune dysregulation.6Baloh C Reddy A Henson M Prince K Buckley R Lugar P. 30-year review of pediatric- and adult-onset CVID: clinical correlates and prognostic indicators.J Clin Immunol. 2019; 39: 678-687Crossref PubMed Scopus (21) Google Scholar A CVID diagnosis established after the fourth year of life requires a suggestive clinical history, a marked reduced total immunoglobulin G (IgG) serum concentration with low IgA or IgM, poor responses to vaccines (or absent isohemagglutinins), or low IgD⁻/CD27⁺/CD19⁺ switched memory B (smB) cells, and no evidence of profound T-cell deficiency; in addition, other causes of secondary hypogammaglobulinemia must be excluded.6Baloh C Reddy A Henson M Prince K Buckley R Lugar P. 30-year review of pediatric- and adult-onset CVID: clinical correlates and prognostic indicators.J Clin Immunol. 2019; 39: 678-687Crossref PubMed Scopus (21) Google Scholar We observed retrospectively the ability of patients with CVID to produce SARS-CoV-2 spike-specific IgG in response to the 2-dose BNT162b2 regimen as part of the national vaccination program of Israel. Furthermore, we looked for a correlation with CVID subgroups based on flow cytometry B-cell immunophenotyping.7Wehr C Kivioja T Schmitt C et al.The EUROclass trial: defining subgroups in common variable immunodeficiency.Blood. 2008; 111: 77-85Crossref PubMed Scopus (645) Google Scholar All patients diagnosed as having CVID (n = 17) were treated with intravenous immunoglobulin (IVIG) every 4 weeks at Lin, Zvulun, and Carmel Medical Centers belonging to Clalit Health Services in Haifa, Israel. Revised European Society for Immunodeficiencies registry criteria6Baloh C Reddy A Henson M Prince K Buckley R Lugar P. 30-year review of pediatric- and adult-onset CVID: clinical correlates and prognostic indicators.J Clin Immunol. 2019; 39: 678-687Crossref PubMed Scopus (21) Google Scholar were used for CVID diagnosis. Between December 23, 2020, and March 6, 2021, all patients with CVID were vaccinated with the 2-dose BNT162b2 regimen. Blood samples were taken at least 14 days after the second dose, before receiving IVIG to measure SARS-CoV-2 S1 IgG levels and obtain and updated flow cytometry analysis. Day 14 was chosen because mRNA vaccine-induced B-cell responses typically peak 2 weeks after the second dose and SARS-COV-2 neutralizing titers seem to follow this pattern.5Sahin U Muik A Derhovanessian E et al.COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses.Nature. 2020; 586: 594-599Crossref PubMed Scopus (1159) Google Scholar SARS-CoV-2 S1 IgG values more than 50 AU/mL were considered protective by the Abbott Architect SARS-CoV-2 S1 IgG assay (manufacturer's data: sensitivity, 98.1% [95% confidence interval, 89.9%-99.7%]; specificity, 99.6% [95% confidence interval, 99.2%-99.8%]) performed by the serology laboratory of Clalit Health Services. There were 2 patients who were excluded: COVID-19 was detected on prevaccination polymerase chain reaction testing in one patient, whereas the second was receiving ongoing immunosuppressive medication (rituximab). The remaining 15 patients were divided into the following 3 groups, based on their results: group B−, total circulating CD19⁺ B cells less than or equal to 1%; group B+/smB+, total circulating CD19⁺ B cells greater than 1% and smB cells greater than 2%; and group B+/smB−, total circulating CD19⁺ B cells greater than 1% and smB cells less than or equal to 2%.7Wehr C Kivioja T Schmitt C et al.The EUROclass trial: defining subgroups in common variable immunodeficiency.Blood. 2008; 111: 77-85Crossref PubMed Scopus (645) Google Scholar Table 1 provides the cohort characteristics and their serologic results. Patients ranged from the age of 22 to 81 years (average, 49.8 years). Blood serology samples were taken 14 to 61 days after the second dose (average, day 31). In addition, 4 patients (26.67%) did not produce SARS-CoV-2 S1 IgG after both BNT162b2 doses, whereas 11 (73.33%) had protective titers ranging from 58 AU/mL to 9780.3 AU/mL (average, 1764.00; median, 307.3). Note that although the 2 patients in group B− had negative serology result, all 6 patients in group B+/smB+ had seropositive result. For group B+/smB−, 5 of 7 patients were seropositive. Interestingly, the 2 patients with negative serology had a total peripheral CD19⁺ B-cell percentage below the lower limit for the normal range (6%-19%),7Wehr C Kivioja T Schmitt C et al.The EUROclass trial: defining subgroups in common variable immunodeficiency.Blood. 2008; 111: 77-85Crossref PubMed Scopus (645) Google Scholar whereas that of the 5 seropositive patients was within the normal range. It has been found that patients with CVID with nearly absent total CD19⁺ B cells (≤1%) have severe defects of early B-cell differentiation, whereas severely reduced smB cells (≤2%) indicate defective germinal center (GC) development.7Wehr C Kivioja T Schmitt C et al.The EUROclass trial: defining subgroups in common variable immunodeficiency.Blood. 2008; 111: 77-85Crossref PubMed Scopus (645) Google Scholar Our results suggest that patients with both CD19⁺ B% cells lower than the normal range (6%-19%) and reduced smB cells (≤2%) have prominent GC generation impairment. In line with this idea, the GC has been found to play a pivotal role on protective antibody generation for SARS-CoV-2 mRNA vaccines and that GC responses are strongly correlated with neutralizing antibody production.8Lederer K Castaño D Gómez Atria D et al.SARS-CoV-2 mRNA vaccines foster potent antigen-specific germinal center responses associated with neutralizing antibody generation.Immunity. 2020; 53 (e5): 1281-1295Abstract Full Text Full Text PDF PubMed Scopus (201) Google ScholarTable 1Cohort CharacteristicsaPhenotypes are not listed because no correlation was found between a specific phenotype and vaccination response; there are no comorbidities that might have affected patients’ BNT162b2 response. (n = 15) and Serologic ResultsGroupSexAge (y)Flow cytometry resultsSecond vaccination/serology interval (d)SARS-CoV-2 S1 IgG (AU/mL)B−MbReceiving 10 mg prednisone for inflammatory bowel disease.51B% = 129<21F30B% = 014<21B+/smB+M50B% = 4, smB% = 914307.3M72B% = 3, smB% = 1434300.4M22B% = 9, smB% = 3184924.9M81B% = 2, smB% = 104158F28B% = 9, smB% = 11159780.3M61B% = 11, smB% = 7282178.3B+/smB−FcReceiving 40 mg prednisone for autoimmune hemolytic anemia.44B% = 8, smB% = 061205.7F62B% = 20, smB% = 03684.6F48B% = 8, smB% = 255625.8F40B% = 17, smB% = 018109.9M54B% = 6, smB% = 248828.7F38B% = 4, smB% = 125<21F66B% = 5, smB% = 030<21Abbreviations: B%, percentage of total circulating CD19+ B cells as fraction of lymphocytes; smB%, percentage of IgD−/CD27+/CD19+ switch memory B cells as fraction of total circulating CD19+ B cells; F, female; IgG, immunoglobulin G; M, male; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.a Phenotypes are not listed because no correlation was found between a specific phenotype and vaccination response; there are no comorbidities that might have affected patients’ BNT162b2 response.b Receiving 10 mg prednisone for inflammatory bowel disease.c Receiving 40 mg prednisone for autoimmune hemolytic anemia. Open table in a new tab Abbreviations: B%, percentage of total circulating CD19+ B cells as fraction of lymphocytes; smB%, percentage of IgD−/CD27+/CD19+ switch memory B cells as fraction of total circulating CD19+ B cells; F, female; IgG, immunoglobulin G; M, male; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2. A possible study limitation may be that patients acquired protective antibodies from the IVIG. Nevertheless, all patients with CVID were on PRIVIGEN (CSL Behring, Bern, Switzerland; manufacture date: January 14, 2020). Hence, IVIG-stimulated cross-reactive antibodies cannot explain the wide differences between protective antibody levels after vaccination. The presence of considerable protective COVID-19 antibody levels in these products is doubtful. In addition, although 2 patients were receiving steroids, their serologic results (Table 1) indicate that steroid use was not responsible for the lack of response to BNT162b2 vaccination. In conclusion, vaccination of patients with CVID with the 2-dose BNT162b2 regimen is important, because most of them will produce specific SARS-CoV-2 S1 antibodies in good titers. Nevertheless, our data indicate that total peripheral CD19⁺ B cells below the normal range (6%-19%) together with smB cells (≤2%) or total peripheral CD19⁺ B cells (≤1%) may predict unresponsiveness to BNT162b2. Our data require further validation in larger populations with CVID and subsequent research to detect the rate of postvaccination antibody decay compared with that of the general population." @default.
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• W3187336349 title "Specific antibody response of patients with common variable immunodeficiency to BNT162b2 coronavirus disease 2019 vaccination" @default.
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