Safety and immunogenicity protocol of vaccination for SARS-COV 2 in solid organ transplant patients in Argentina-sociedad Argentina de trasplante
Maria C Giordani7, Jorge Geffner1, Laura A Barcan2, Astrid Smud2, Susana k Villamil Cortez7, Vladimir A Suarez Muñoz7, Pilar Remersano1, Silvia R Groppa7, Cesar A Belziti3, Marcelo Ferreira4, Silvia Dipietrantonio6, Roberto Sabbatiello5, Graciela N Svetliza9, Diego J Arrigo10, Alejandra M Villamil8.
1INBIRS, UBA-CONICET, Ciudad de Buenos Aires, Argentina; 2Infectology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina; 3Cardiology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina; 4Nephrology, IOT- Clinica de Nefrologia, Misiones, Argentina; 5Nephrology, Hospital Gral. de Agudos Dr. Cosme Argerich, Ciudad de Buenos Aires, Argentina; 6Nephrology, Hospital del Cruce Dr. Nestor Kirchner, Buenos Aires, Argentina; 7Nephrology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina; 8Hepatology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina; 9Neumonology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina; 10Virology, Hospital Italiano de Buenos Aires, Ciudad de Buenos Aires, Argentina
Sociedad Argentina de Trasplante.
Introduction: Coronavirus 19 disease (COVID-19) in solid organ transplant recipients (SOT) is associated with increased morbidity and mortality. The WHO recommends vaccination as a primary prevention tool. We evaluate the safety and generation of Ab Anti-Spike in SOT patients at 28 and 90 days after Covid 19 vaccination schedule.
Methods: This is a Multicenter prospective study in SOT with a complete vaccination schedule who agreed to participate in the study. Demographic, vaccination schedule, adverse events and transplant variables were collected. Anti-spike antibodies were evaluated by the COVIDAR-IgG method at the Universidad de Buenos Aires School of Medicine.
Results: 244 SOT patients were included from September 2021 to February 2022. Median age was 50 (IQR 41-61, women 47%).Transplant type: 62.1% kidney, 14.8% cardiac, 15.6% liver, 0.6% pancreas, kidney-pancreas 5.3% and 1.6% lung. Deceased donors 70%. The median time since transplantation to vaccination was 72.3 months (IQR 30.6 -140). Only 10.3% of patients had developed rejection one year prior to vaccination and 3.3% of patients rejected post-vaccination. 146 ptes (60.3%) had triple immunosuppressive maintenance regimen (steroids +calcineurin inhibitors (ICN) + antiproliferatives), 46ptes19.8% (received double regimen without steroids and 12 ptes 5.2% monotherapy with ICN. Vaccination scheme was: Sputnik 33%, Sputnik-AstraZeneca 5.4%, Sputnik-Moderna 19.6%, Sinopharm 6.7%, AstraZeneca 35%. The eGFR (CKD-EPI Cr) in patients who had a positive anti-Spike antibody response was higher than in those with no response: 60 ml/min/1.73 m2 (IQR 41.65 - 78.15) vs 49.4 ml/min/1.73 m2 (IQR 35.60 - 65.40) (p=0.010). Vaccine-related adverse events were observed in 22.3% of patients, 76% were mild. Patients with no response at 28 days had triple immunosuppressive regimen (p < 0.001, RR 0.419 (0.26 -0.66) and lower time post-transplant 55 vs 107 months (p < 0.001). Patients infected with Covid-19 prior to vaccine (13%), had a higher response rate: p <0.0001 RR 2.58 (1.90-3.51). Patients previously infected with Covid-19 and Anti-Spike Ab + at 28 days had a higher response at 90 days. 16% of patients were infected with COVID-19 after vaccination.
Conclusion: In our SOT population, a lower generation rate of anti-spike Ab was observed, compared to the reported in the general population. Lower eGFR and the triple IS regimen were associated with a lower response rate. Covid-19 prior to vaccination was associated with a higher antibody response to the vaccine.
