Preliminary Data of the Safety and Immunogenicity Protocol of Vaccination for SARS-CoV 2 in Solid Organ Transplant Patients in Argentina

ABSTRACT

Purpose: To evaluate the safety and generation rate of Ab anti spike rate in SOT patients at 28 and 90 days after completing the Covid 19 vaccination scheme. Method(s) Multicenter prospective study in SOT with a complete vaccination scheme who agreed to participate in the study . Demographic , vaccination schedule;time;adverse effects and transplant variables were collected. The generation rate of antispike antibodies was evaluated by the COVIDAR-IgG method at the Universidad de Buenos Aires School of Medicine. Result(s) 113 SOT patients were included (September 6th to October 4th). Median age was 53 (IQR 42.5-63, women 36.8%). Transplant type 72.8% renal , 13.1% cardiac, 12.3% liver, 0.9% pancreas and 0.9% lung. Deceased donors 71.1%. The median time after transplantation to vaccination was 65 months (IQR 30 120 R 2-429). Only 7% of patients developed rejection within the year prior to vaccination and no patient rejected post vaccination. 74.3% (n 84) had triple immunosuppressive maintenance regimen (steroids + calcineurin inhibitors (ICN) + antiproliferative), 24 pts (21.1%) double regimen WITHOUT steroids and 5 (4.3%) monotherapy with IC. Vaccination schedule Sputnik 14.5%, Sputnik-Astrazeneca 4.4%, Sputnik-Moderna 28.9%, Sinopharm 3.5%, Astrazeneca 34.2%. Vaccine-related adverse events were observed in 18.4% of patients, 82% were mild. 40% of SOT responded with Antispike Ab , with a lower response rate in kidney transplantation p <0.0007 RR 0.48 (0.32-0.71) and use of triple immunosuppressive maintenance regimen p <0.00009 RR 0.419 (0.26 -0.66). Patients previously infected with Covid-19 prior to vaccine (11.45% pts), had a higher response rate p <0.0001 RR 2.58 (1.90-3.51).No patients developed COVID-19 after vaccination. Conclusion(s) In our SOT population, a lower generation rate of anti-spike Ab was observed, compared to the reported in the general population. Renal Tx 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.