Carla Santos-Araújo1,2, Pedro Mota Veiga3,4, Mário João Santos5, Lidia Santos6,7, Catarina Romãozinho7,8, Mónica Silva6, Carlos Lucas1, Mary Luz Duarte5, Mathias Haarhaus1,9, Michael Haase1,10,11, Fernando Macário1. 1. Diaverum AB, Malmö, Sweden. 2. Cardiovascular Research and Development Unit, Faculty of Medicine, Porto, Portugal. 3. Polytechnic Institute of Viseu, School of Education, Viseu, Portugal. 4. NECE Research Unit in Business Sciences, University of Beira Interior, Covilhã, Portugal. 5. Department of Serology of Unilabs, Porto, Portugal. 6. Diaverum Hemodialysis Unit of Aveiro, Aveiro, Portugal. 7. Department of Nephrology, Hospital and University Center of Coimbra, Coimbra, Portugal. 8. Nefrovida Diaverum Hemodialysis Unit of Coimbra, Coimbra, Portugal. 9. Division of Renal Medicine, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. 10. Medical Faculty, Otto-von-Guericke University Magdeburg, Magdeburg, Germany. 11. Diaverum Renal Care Center, Potsdam, Germany.
Abstract
BACKGROUND: Vaccination programs are essential for the containment of the coronavirus disease 2019 pandemic, which has hit haemodialysis populations especially hard. Early reports suggest a reduced immunologic response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in dialysis patients, in spite of a high degree of seroconversion. We aimed to identify risk factors for a reduced efficacy of an mRNA vaccine in a cohort of haemodialysis patients. METHOD: In a multicentre study, including 294 Portuguese haemodialysis patients who had received two doses of BNT162b2 with a 3-week interval, immunoglobulin G-class antibodies against the SARS-CoV-2 spike protein were determined 3 weeks after the first dose (M1) and 6 weeks after the second dose (M2). The threshold for seroconversion was 10 UR/mL. Demographic and clinical data were retrieved from a quality registry. Adverse events were registered using a questionnaire. RESULTS: At M2, seroconversion was 93.1% with a median antibody level of 197.5 U/mL (1.2-3237.0) and a median increase of 180.0 U/mL (-82.9 to 2244.6) from M1. Age [beta -8.9; 95% confidence interval (95% CI) -12.88 to -4.91; P < 0.0001], ferritin >600 ng/mL (beta 183.93; 95% CI 74.75-293.10; P = 0.001) and physical activity (beta 265.79; 95% CI 30.7-500.88; P = 0.03) were independent predictors of SARS-CoV-2 antibody levels after two vaccine doses. Plasma albumin >3.5 g/dL independently predicted the increase of antibody levels between both doses (odds ratio 14.72; 95% CI 1.38 to 157.45; P = 0.03). Only mild adverse reactions were observed in 10.9% of patients. CONCLUSIONS: The SARS-CoV-2 vaccine BNT162b2 is safe and effective in haemodialysis patients. Besides age, iron status and nutrition are possible modifiable modulators of the immunologic response to SARS-CoV-2 mRNA vaccines. These data suggest the need for an early identification of populations at higher risk for diminished antibody production and the potential advantage of the implementation of oriented strategies to maximize the immune response to vaccination in these patients.
BACKGROUND: Vaccination programs are essential for the containment of the coronavirus disease 2019 pandemic, which has hit haemodialysis populations especially hard. Early reports suggest a reduced immunologic response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in dialysis patients, in spite of a high degree of seroconversion. We aimed to identify risk factors for a reduced efficacy of an mRNA vaccine in a cohort of haemodialysis patients. METHOD: In a multicentre study, including 294 Portuguese haemodialysis patients who had received two doses of BNT162b2 with a 3-week interval, immunoglobulin G-class antibodies against the SARS-CoV-2 spike protein were determined 3 weeks after the first dose (M1) and 6 weeks after the second dose (M2). The threshold for seroconversion was 10 UR/mL. Demographic and clinical data were retrieved from a quality registry. Adverse events were registered using a questionnaire. RESULTS: At M2, seroconversion was 93.1% with a median antibody level of 197.5 U/mL (1.2-3237.0) and a median increase of 180.0 U/mL (-82.9 to 2244.6) from M1. Age [beta -8.9; 95% confidence interval (95% CI) -12.88 to -4.91; P < 0.0001], ferritin >600 ng/mL (beta 183.93; 95% CI 74.75-293.10; P = 0.001) and physical activity (beta 265.79; 95% CI 30.7-500.88; P = 0.03) were independent predictors of SARS-CoV-2 antibody levels after two vaccine doses. Plasma albumin >3.5 g/dL independently predicted the increase of antibody levels between both doses (odds ratio 14.72; 95% CI 1.38 to 157.45; P = 0.03). Only mild adverse reactions were observed in 10.9% of patients. CONCLUSIONS: The SARS-CoV-2 vaccine BNT162b2 is safe and effective in haemodialysis patients. Besides age, iron status and nutrition are possible modifiable modulators of the immunologic response to SARS-CoV-2 mRNA vaccines. These data suggest the need for an early identification of populations at higher risk for diminished antibody production and the potential advantage of the implementation of oriented strategies to maximize the immune response to vaccination in these patients.
Authors: Nayara Panizo; Eliseo Albert; Elena Giménez-Civera; Maria Jesús Puchades; Luis D'Marco; Lorena Gandía-Salmerón; Estela Giménez; Ignacio Torre; Asunción Sancho; Eva Gavela; Miguel Gonzalez-Rico; Marco Montomoli; Carmen Maria Perez-Baylach; Begoña Bonilla; Camila Solano; Mª Fernanda Alvarado; Isidro Torregrosa; María Jesús Alcaraz; José Luis Górriz; David Navarro Journal: Clin Kidney J Date: 2022-04-09
Authors: Ewa Kwiatkowska; Krzysztof Safranow; Iwona Wojciechowska-Koszko; Paulina Roszkowska; Violetta Dziedziejko; Marek Myślak; Jacek Różański; Kazimierz Ciechanowski; Tomasz Stompór; Jarosław Przybyciński; Piotr Wiśniewski; Norbert Kwella; Sebastian Kwiatkowski; Tomasz Prystacki; Wojciech Marcinkowski; Leszek Domański Journal: Biomedicines Date: 2022-03-09