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Abstract
AimsImmunocompromised patients have been excluded from studies of SARS-CoV-2 messenger RNA vaccines. The immune response to vaccines against other infectious agents has been shown to be blunted in such patients. We aimed to analyse the humoral and cellular response to prime-boost vaccination with the BNT162b2 vaccine (Pfizer-BioNTech) in cardiothoracic transplant recipients.Methods and resultsA total of 50 transplant patients [1–3 years post heart (42), lung (7), or heart–lung (1) transplant, mean age 55 ± 10 years] and a control group of 50 healthy staff members were included. Blood samples were analysed 21 days after the prime and the boosting dose, respectively, to quantify anti-SARS-CoV-2 spike protein (S) immunoglobulin titres (tested by Abbott, Euroimmun and RocheElecsys Immunoassays, each) and the functional inhibitory capacity of neutralizing antibodies (Genscript). To test for a specific T-cell response, heparinized whole blood was stimulated with SARS-CoV-2 specific peptides, covering domains of the viral spike, nucleocapsid and membrane protein, and the interferon-γ release was measured (QuantiFERON Monitor ELISA, Qiagen). The vast majority of transplant patients (90%) showed neither a detectable humoral nor a T-cell response three weeks after the completed two-dose BNT162b2 vaccination; these results are in sharp contrast to the robust immunogenicity seen in the control group: 98% exhibited seroconversion after the prime dose already, with a further significant increase of IgG titres after the booster dose (average > tenfold increase), a more than 90% inhibition capability of neutralizing antibodies as well as evidence of a T-cell responsiveness.ConclusionsThe findings of poor immune responses to a two-dose BNT162b2 vaccination in cardiothoracic transplant patients have a significant impact for organ transplant recipients specifically and possibly for immunocompromised patients in general. It urges for a review of future vaccine strategies in these patients.
Highlights
Four vaccines have been approved by the European Medicines Agency (EMA) on base of the phase 3 clinical efficacy studies showing good safety and immunogenicity [6,7,8,9] immunocompromised patients have been excluded from these studies
The commercial SARS-CoV-2 IgG II Quant assay (Abbott, Lake Forrest, IL, USA) is a chemiluminescent microparticle immunoassay (CMIA) which was used for the quantitative measurement of IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2 in human serum on the Alinity I system
This study demonstrates a lack of immunogenicity of the completed prime-boost vaccination with the mRNA SARSCoV-2 vaccine BNT162b2 in cardiothoracic transplant recipients even 3 weeks after the second dose, strongly suggesting that immunosuppressed cardiothoracic organ
Summary
The Covid-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a widespread impact on health, including a substantial mortality among. Vaccination has emerged as a key tool for controlling the pandemic health crisis by preventing severe disease and mortality and by increasing population immunity. To gain more insights in the immunogenicity of mRNA vaccines under immunosuppressive therapy, we analysed the antibody as well as the T-cell response after the first and second dose of the BNT162b2 vaccination in cardiothoracic organ transplant recipients. According to the manufacturer’s recommendation, values below 7.1 BAU/ml were regarded as negative whereas values equal to or above 7.1 BAU/ml were interpreted as positive for IgG antibodies against SARS-CoV-2. Values below 10 RU/ml were regarded as negative whereas values above 10 RU/ml were interpreted as positive as stated by the manufacturer
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