While this study suggests a favorable safety profile, it was not designed to establish the vaccine’s clinical efficacy in this populace or the role of T cell response. in 14 (18%) HT recipients. Immune sera neutralized SARS-CoV-2 pseudo-virus in 8 (57%) of those with IgG anti-RBD antibodies. Immunosuppressive regimen made up of mycophenolic acid was associated with lower odds of an antibody response (OR?=?0.12, value /th /thead Recipient characteristicsAge, years, median (IQR)62.0 (49.0- 68.0)61.5 (47.8- 68.0)62.0 (49.5-68.5).648Female sex, n (%)27 (35.5)5 (35.7)22 (35.5)1.000BMI, kg/m2, (meanSD)26.4 5.428.4 6.626.1 5.1.214Diabetes mellitus, n (%)23 (35.4)4 (36.4)19 (35.2)1.000Hypertension, n (%)48 (73.8)9 (81.8)39 (72.2).777Dyslipidemia, n (%)57 (87.7)9 (81.8)48 (88.9).883Chronic kidney disease, n (%)a29 (37.7)6 (42.9)23 (36.5).890Blood type, n (%).996A24 (42.1)4 (40)20 (42.6)AB6 (10.5)1 (10)5 (10.6)B10 (17.5)2 (20)8 (17)O17 (29.8)3 (30)14 (29.8)Cardiac allograft vasculopathy, n (%)14 (23.3)1 (9.1)13 (26.5).400Immunosuppression databMycophenolic acid therapy, n (%)58 (75.3)5 (35.7)53 (84.1).001Mycophenolate sodium, n (%)41 (53.2)3 (21.4)38 (60.3).019Mycophenolate mofetil, n (%)17 (22.1)2 (14.3)15 (23.8).674Mycophenolate sodium dose, mg, (meanSD)1225.4 385.41386.7 641.71212.6 368.8.458Mycophenolate mofetil dose, mg, (meanSD)1441.2 496.31500 707.11433.3 495.2.865Everolimus therapy, n (%)20 (26.0)9 (64.3)11 (17.5).001Immunosuppression protocol .001Tacrolimus?+?Mycophenolate?+?Prednisone, n (%)32 (41.6)3 (21.4)29 (46)Cyclosporine +Mycophenolate?+?Prednisone n (%)5 (6.4)1 (7.1)4 (6.3)Tacrolimus?+?Mycophenolate, n (%)13 (16.8)0 (0)13 (20.6)Cyclosporine?+?Mycophenolate, n (%)2 (2.6)0 (0)2 (3.2)Cyclosporine?+?Everolimus?+?Prednisone, n (%)3 (3.9)3 (21.4)0 (0)Tacrolimus?+?Everolimus?+?Prednisone, n (%)9 (11.7)3 (21.4)6 (9.5)Mycophenolate?+?Everolimus?+?Prednisone, n (%)3 (3.9)0 (0)3 (4.8)Everolimus?+?Cyclosporine, n (%)2 (2.6)2 (14.3)0 (0)Everolimus?+?Mycophenolate, n (%)2 (2.6)0 (0)2 (3.2)Cyclosporine+ Prednisone, n (%)4 (5.2)1 (7.1)3 (4.8)Tacrolimus?+?Prednisone, n (%)1 (1.3)0 (0)1 (1.6)Tacrolimus?+?Everolimus?+?Mycophenolate?+?Prednisone, n (%)1 (1.3)1 (7.1)0 (0)Chronic prednisone, n (%)58 (75.3)12 (85.7)46 (73.0).513Prednisone dose, mg, median (IQR)2.50 (1.5- 2.5)2.50 (2.1, 2.9)2.5 (0- 2.5).408Tacrolimus trough level, g/L, (meanSD)c8.1 3.76.6 4.48.4 3.5.191Tacrolimus trough level, g/L, median (IQR)c9.00 (5.4, 10.5)5.00 (4.2, 6.7)9.6 (5.7, 10.7).063Cyclosporine trough level, g/L, (meanSD)c91.1 49.380.5 50.996.4 50.0.535Cyclosporine trough level, g/L, median (IQR)c102.5 (54.0, 118.0)58.0 (47.8, 92.3)112.5 (89.3, 122.5).261Laboratory data*Lymphocyte absolute, K/L, n (%)1.4 0.71.5 0.61.4 0.7.575White blood cell, K/L, n (%)6.8 2.36.9 2.66.8 2.3.895Neutrophil absolute, K/L, n (%)4.6 2.04.9 2.74.5 1.8.546Neutrophil/lymphocyte ratio, n (%)4.2 4.63.4 1.84.4 5.0.480Creatinine, mg/dL, n (%)1.2 0.61.2 0.51.2 0.6.963C-reactive protein, mg/L, n (%)7.3 10.810.6 15.06.6 9.7.234Low-density lipoprotein, mg/dL, n (%)85.5 34.199.1 36.382.7 33.2.116Triglycerides, mg/dL, n (%)172.6 69.2181.9 74.1170.7 68.6.599Donor specific antibody, n (%)5 (7.0)2 (15.4)3 (5.2).483Troponin I HS baseline, ng/L, baseline, CACNA2 median (IQR)4.2 (3.0-6.9)4.4 (3.9-6.8)4.1 (3.0-6.8)0.307Troponin I HS post second vaccine, ng/L, median (IQR)4.3 (3.1-7.3)4.3 (3.6-9.3)4.4 (3.0-6.6).172? Troponin, ng/L, median (IQR)0.0 (-0.2- 0.3)0.0 (-0.3, 0.6)0.0 (-0.2- 0.3).537Time-tableHT to second vaccine, years, median (IQR)7.4 (3.3-15.1)9.8 (4.1-17.3)7.4 (3.2-14.8).615Second vaccine to antibody testing, days (meanSD)20.6 10.020.5 10.420.7 10.0.955Follow-up from second vaccine, days (meanSD)40.8 7.640.3 4.140.9 8.2.781EchocardiographyEjection fraction, baseline, % Demethoxydeacetoxypseudolaric acid B analog (meanSD)58.9 (3.2)57.9 (4.7)59.2 (2.7).148Ejection fraction, post second vaccine, % (meanSD)59.1 (3.0)57.5 (5.0)59.4 (2.3).057? Ejection fraction, % (meanSD)0.03 (0.72)0.00 (0.00)0.04 (0.79).875 Open Demethoxydeacetoxypseudolaric acid B analog in a separate window BMI, Body mass index; HT, heart transplantation; SD, standard deviation. aDefined as estimated glomerular filtration rate (GFR) 60 mL/min/1.73 m2 using the CKD-EPI formula. bOn day of antibody testing. cWhole blood trough levels were measured on the day of antibody testing (at least 4 half-lives on fixed-dose regimen).A Demethoxydeacetoxypseudolaric acid B analog chi-square test was used for comparison of categorical variables between the groups. Student’s em t /em -test was performed for comparison of normally distributed continuous variables, and the Mann-Whitney U test was used for non-normal distribution. Among the vaccine recipients, 60% and 53% reported at least one adverse event after the first and second doses, respectively. By age group, 77% and 69% in the younger group (aged 55 years) and 51% and 45% in the older group (aged 55 years) reported at least one adverse event after the first and second Demethoxydeacetoxypseudolaric acid B analog doses, respectively. Among the vaccine recipients, 56% and 49% reported at least one local injection site reaction (Table S1) after the first and second doses, respectively. By age group, 80% and 72% in the younger group and 44% and 38% in the older group reported at least one local reaction after the first and second Demethoxydeacetoxypseudolaric acid B analog doses, respectively. Pain at the injection site was the most frequent local reaction, and was more frequently reported by the younger age group. At least one systemic reaction (mainly fatigue or headache) after the first and second doses was reported by 37% and 49% of the recipients, respectively (Table S2). The frequency of systemic adverse events was higher in the younger than the older age group, being 72% vs 20% and 100% vs 22% after the first and second doses, respectively. The majority of systemic events were moderate or moderate, and no emergency room visits or hospitalizations for adverse events were reported. Patients who produced antibodies did not demonstrate higher rates of adverse events.