key: cord-0291417-vw326uf8 authors: Laham, G.; Martinez, A. P.; Rojas Gimenez, W.; Amaya, L.; Abib, A.; Echegoyen, N.; Diaz, C.; Lucero, A.; Martelli, A.; Videla, C.; Neukam, K.; Di Lello, F. A. title: Assessment of the humoral response to the homologous Gam-COVID-Vac (Sputnik V) or heterologous Sputnik V/mRNA-1273 (Moderna) vaccination against SARS-CoV-2 in dialysis patients. date: 2022-05-19 journal: nan DOI: 10.1101/2022.05.13.22275049 sha: 9f35edf73e3060c7a6cc65024dc26e51cd303b75 doc_id: 291417 cord_uid: vw326uf8 Introduction: The humoral response to vaccines is the most used tool to evaluate the protection against SARS-CoV-2 infection. Dialysis patients are a high-risk population and have a reduced immune response to vaccination. Objective: To assess the humoral response to homologous Gam-COVID-Vac (Sputnik V) and heterologous Sputnik V/mRNA-1273 (Moderna) vaccination in dialysis patients. Methods: SARS-CoV-2 anti-spike IgG (RBD) concentration was estimated 3-16 weeks after complete vaccination. Reactogenicity was evaluated until day 7 by patients self-reported side events. Results: 107 participants were enrolled [n=84 homologous (SpV/SpV), n=23 heterologous (SpV/Mod)]. Median (IQR) age was 64 (50-75) years old and 79 (73.8%) were male. Additionally, 19 (22.6%) of the SpV/SpV and 4 (17.4%) of the SpV/Mod group had a prior confirmed SARS-CoV-2 infection (p=0.589). In the overall population, 103 patients reached seroconversion (96.3%). Anti-S-RBD IgG median titers (IQR) were higher in the heterologous [1222 (288-5680) BAU/mL] than in the homologous scheme [447 (100-1551) BAU/mL], p=0.022. In a linear model adjusted for age and gender, previous SARS-COV-2 infection (B: 1944.3; CI95: 1136.2-2753.4; p<0.001), and SpV/Mod vaccination scheme (B: 1241.5; CI95: 420.39-2062.6; p=0.003) were independently associated with anti-S-RBD levels. Finally, a higher frequency of adverse effects was associated with the heterologous scheme, although they were well tolerated by all individuals. Conclusion: The present study provides evidence that the homologous SpV/SpV and heterologous SpV/Mod schemes showed good efficacy and safety under dialysis conditions. These results could be useful for future vaccination strategies, especially aimed at this risk group. Patients under dialysis are at increased risk for severe coronavirus infectious disease 2019 60 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) than 61 the general population, with reported mortality rates of up to 28.3% [1-3-] . This situation mainly 62 obeys to a considerably higher mean patients' age (approximately 65 years old) and the frequent 63 presence of comorbid conditions such as obesity, diabetes, and high blood pressure that are In this scenario, the present study aimed to assess the humoral response to homologous Sputnik 78 V and heterologous Sputnik V/Moderna vaccination in dialysis patients. 79 80 81 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 6 Reactogenicity 108 All patients were invited to complete an online questionnaire to report all possible post-boost 109 vaccination adverse events and required medical assistance. The intensity of adverse effects was 110 graded as mild, moderate, and severe depending on the interference with daily activities. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. CoV-2 infection (p=0.589). Table 1 shows detailed characteristics of the study population. 158 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The present work shows that the implementation of SpV/SpV or SpV/Mod vaccination schemes 183 against SARS-CoV-2 in patients under dialysis was effective leading to a seroconversion rate of 184 96.3%. Overall, the heterologous scheme showed an anti-S-RBD level almost 3-fold higher than 185 the homologous one. Moreover, both vaccination schemes were well tolerated, and no medical 186 assistance was required. To our knowledge, this is the first study on the heterologous scheme including Sputnik V and All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 Regarding PROT-80, almost 50% of the studied population achieved this threshold while 208 heterologous scheme and prior SARS-CoV-2 infection were associated with higher PROT-80 209 proportions. Furthermore, the multivariate analysis showed that the 80% vaccine efficacy was not In the present study, there were no anti-S-RBD IgG significant differences between genders. Additionally, the current study found that the body mass index, time on dialysis, weekly total Kt/V, 230 as well as other evaluated laboratory parameters showed no association with Anti-S-RBD or 231 PROT-80 levels. There are previous contradictory results regarding this issue. While some 232 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 authors, as we did, could not find an association between these variables and the anti-S-RBD IgG In conclusion, both analyzed vaccine schemes were immunogenic and showed a high 255 seroconversion rate. In addition, a significant correlation was found between higher anti-S-RBD IgG titers and a confirmed prior infection with SARS-CoV-2 for both schemes. Moreover, the 257 heterologous scheme was also associated with a better humoral response. Finally, local and 258 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 systemic adverse effects were scarce and mostly mild, demonstrating that both schemes are safe 259 and well-tolerated. These findings should promote patients on dialysis to receive these 260 immunization schemes. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 Antibody Response to mRNA SARS-CoV-2 Vaccine Safety and Tolerability of the BNT162b2 412 mRNA COVID-19 Vaccine in Dialyzed Patients Real-world data shows increased reactogenicity in 415 adults after heterologous compared to homologous prime-boost COVID-19 vaccination Humoral immunogenicity and tolerability of 420 heterologous ChAd/BNT compared with homologous BNT/BNT and ChAd/ChAd SARS-CoV-2 421 vaccination in hemodialysis patients: A multicenter prospective observational study No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted High blood pressure, n (%) Polycystic kidney disease, n (%) Glomerular diseases, n (%) C-reactive protein* (mg/dL) No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 384 All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022 Weekly total Kt/V median, Hemoglobin, Albumin, C-reactive protein, Transferrin saturation, and Body mass index showed no association with Anti-S-RBD or PROT-80. All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this preprint this version posted May 19, 2022. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this preprint this version posted May 19, 2022. All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.The copyright holder for this preprint this version posted https://doi.org/10.1101 https://doi.org/10. /2022