Immunogenicity and safety of a third dose of anti-SARS-CoV-2 BNT16b2 vaccine in liver transplant recipients.

ABSTRACT

BACKGROUND & AIMS: A strategy to improve the low rate of anti-SARS-CoV-2 mRNA vaccine-induced immunogenicity in liver transplant recipients (LTs) is urgently needed. METHODS: We analyzed the rate of positive (≥0.8 U/ml) anti-SARS-CoV-2 receptor domain binding protein (RBD) antibody response two months after a third dose of the BNT16b2 vaccine in 107 LTs who completed the second vaccine dose seven months earlier. RESULTS: A positive anti-SARS-CoV-2-s-RBD antibody response after the third vaccine dose was detected in 98 (91.6%) LTs compared to 82 (76.6%) after the second vaccine dose (p=0.003). The median of anti-SARS-CoV-2 RBD antibody titers increased from 22.9 U/ml six months after the second to 3500 U/ml two months after the third vaccine dose (p<0.001). Fourteen (14.3%) responder patients presented antibody titers <100 U/ml, 57 (58.2%) between 100 and 9999 U/ml and 27 (27.6%) ≥10000 U/ml. Seropositivity after the second dose was maintained after the third dose. Independent predictors of antibody response failure after the third vaccine dose were taking a higher daily dose of mycophenolate mofetil (MMF, p<0.001) and had a lower (<60 ml/min/1.73m2 ) estimated glomerular filtration rate (p=0.007). Nine (9.1%) LTs experienced symptomatic SARS-CoV-2 infection after the third vaccine dose. Median antibody titers were not statistically different between infected and not infected LTs (1325 vs 3515 U/ml, p=0.678). CONCLUSIONS: The third dose of the BNT16b2 vaccine increased the number of LTs who developed a positive anti-SARS-CoV-2 s-RBD antibody response. A proportion of patients remained unresponsive, mainly for modifiable factors, such the use of MMF or multiple immunosuppressants.