Abstract
Background: Data about SARS-CoV-2 vaccines efficacy in renal transplant recipients (RTR) are lacking.
Methods: To reveal predictors for humoral response to BNT162b2 vaccine among RTR, patients were divided into positive (N = 42) and negative (N = 78) response groups based on receptor-binding domain (RBD) immunoglobulin G (IgG) ≥1.1 and neutralizing antibodies (NA) ≥16 dilution versus RBD IgG <1.1 or NA <16, respectively. NA were detected using a SARS-CoV-2 pseudo-virus.
Results: NA were detected in only 42 of 120 (35%) of RTR versus 197 of 202 (97.5%) immunocompetent controls (P < 0.001). NA geometric mean titers in RTR were significantly lower versus the control group {83.7 (95% confidence interval [CI], 50.5-138.8) versus 482 (95% CI, 411-566), P < 0.001}. In a multivariable analysis, mycophenolic acid (MPA) dose and hemoglobin level were found to be independent predictors for antibody response in RTR. A positive response rate of 27% versus 63% was observed in patients on and off MPA, respectively. An increase in MPA dose by 1 mg/kg weight reduced the odds for a positive response by 17% (odds ratio = 0.83; 95% CI, 0.75-0.92; P < 0.001). Geometric mean titers for RBD IgG were significantly reduced as MPA daily dose increased. Hemoglobin blood level <13 g/dL reduced the antibody response by 63% (P = 0.04). Pain at the injection site after the second vaccine dose was significantly higher in the responders versus nonresponders (20.5% versus 5.5%, P = 0.01).
Conclusions: Only 35% of RTR develop NA to the BNT162b2 mRNA vaccine. MPA is a major suppressor of antibody response in RTR.
【초록키워드】 neutralizing antibody, SARS-CoV-2, IgG, Efficacy, BNT162b2 vaccine, Neutralizing antibodies, Antibody Response, SARS-CoV-2 vaccines, SARS-CoV-2 vaccine, vaccine dose, BNT162b2, Immunoglobulin G, Receptor-binding domain, Humoral response, Immunoglobulin, RBD, Patient, Control, hemoglobin, predictor, Responder, group, BNT162b2 mRNA, BNT162b2 mRNA vaccine, Blood level, dose, Odds ratio, independent predictors, humoral, Dilution, response rate, mycophenolic acid, geometric mean, control group, 95% CI, 95% confidence interval, domain, multivariable analysis, geometric mean titers, RBD IgG, injection, responders, injection site, positive response, renal, positive, geometric mean titer, recipient, daily dose, significantly lower, pseudo-virus, develop, significantly, reduced, increase in, significantly higher, the antibody response, independent predictor, 【제목키워드】 SARS-CoV-2, Transplant, mRNA, response, recipient,