Original Paper Nephron Clin Pract 2014;128:341–344 DOI: 10.1159/000368410
Received: September 11, 2013 Accepted: August 4, 2014 Published online: December 19, 2014
Safety and Effectiveness of a 2009 H1N1 Vaccine in Chronic Kidney Disease Children Osman Donmez a, b Okan Akaci a Nurhan Albayrak c Ayse Altas c Departments of a Pediatric Nephrology and b Rheumotalogy, School of Medicine, University of Uludag, Bursa, and c Refik Saydam National Public Health Agency, Unit of Virology, Ankara, Turkey
Key Words Child · Chronic kidney diseases · Dialysis · Influenza · Renal transplantation
Abstract Background/Aims: Influenza vaccination is the most effective method for preventing influenza infection and its complications. The risk groups are children with chronic kidney diseases (CKDs) such as children on peritoneal dialysis (PD) and hemodialysis (HD), predialysis CKD (pCKD) and renal transplant (RTx) patients and immunosuppressed children. The aim of the present study was to assess the safety and immunogenicity of a single administration of a monovalent inactivated pandemic (H1N1) 2009 vaccine in children with CKD. Methods: Patients were given a single intramuscular injection of 0.5 ml of monovalent inactivated vaccine. Results: Totally, there were 25 pediatric patients with a diagnosis of CKD (16 PD, 2 HD, 3 pCKD and 4 RTx). Seroconversion was observed in 15 of the 16 patients with PD. Seroconversion occurred in all patients undergoing pCKD and HD. However, 3 of the RTx patients were seronegative. Conclusion: This study demonstrated a high level of immunogenicity and safety of an (H1N1) 2009 influenza vaccine in children with CKD. © 2014 S. Karger AG, Basel
© 2014 S. Karger AG, Basel 1660–2110/14/1284–0341$39.50/0 E-Mail [email protected] www.karger.com/nec
Introduction
In April 2009, the emergence of swine flu caused an influenza pandemic in humans. Influenza infection causes serious morbidity and mortality. Most of the H1N1-infected people were children and young adults [1]. Influenza vaccination is the most effective method for preventing influenza infection and its complications. Infection rates of seasonal influenza were generally the highest in children, ranging from 25 to 43% [2]. Thus, the World Health Organization (WHO) recommends that vaccination efforts should initially focus on children who are at a higher risk for infections or related complications. According to these recommendations, attention should be paid to children with chronic kidney diseases (CKDs) such as children on peritoneal dialysis (PD) and hemodialysis (HD), predialysis CKD (pCKD) and renal transplant (RTx) patients and immunosuppressed children [3]. The morbidity and mortality associated with infectious diseases is very high in patients undergoing dialysis and renal transplantation [4]. In dialysis patients, the death rate from influenza (H1N1) was reported to be 5%, with the main cause of death being pneumonia [5]. Very few studies have been conducted to investigate the efficacy of influenza vaccination in children with Dr. Okan Akaci Department of Pediatric Nephrology School of Medicine, University of Uludag TR–16059 Görükle, Bursa (Turkey) E-Mail okanakaci @ gmail.com
chronic renal failure. The aim of this study was to assess the safety and immunogenicity of a single dose of a monovalent inactivated pandemic (H1N1) 2009 vaccine in children with CKD.
Materials and Methods Patients This study was performed between October and December 2009 at Uludag University Faculty of Medicine, Pediatric Nephrology and Rheumatology Unit, Bursa, Turkey. All subjects provided their written informed consent. The study design was approved by the local ethics committee. Totally, 25 pediatric patients with a diagnosis of CKD (16 PD, 2 HD, 3 pCKD and 4 RTx) and 18 children as a control group were included in this study. All children were older than 7 years. None of the patients had received vaccination against the 2009 H1N1 virus before. Those who had had a respiratory or febrile infection within the last month in their history, who developed a hypersensitivity reaction to vaccination and who were allergic to eggs were excluded from the study. All RTx patients were on a standard immunosuppression regimen (triple therapy; calcineurin inhibitors, mycophenolate sodium and prednisolone). Immunogenicity Assay – Hemagglutination Inhibition Assay A single intramuscular injection (deltoid muscle) of 0.5 ml influenza A (H1N1) 2009 monovalent inactivated vaccine (0.5 ml prefilled syringe; Sanofi-Pasteur®) was administered. The vaccine did not contain live virus particles. Before vaccination and 21 or 28 days after vaccination, serum samples were obtained from all patients. Serum aliquots were stored at –80 ° C in the deep-freezer until analyses at Virology Laboratories of Ankara Refik Saydam Hıfzıssıhha Institute took place. To measure antibody response against H1N1, a hemagglutination inhibition (HI) test was used. The HI assay presented the highest reciprocal dilution which induced complete HI. No antibody response means that the HI antibody titer is
Received: September 11, 2013 Accepted: August 4, 2014 Published online: December 19, 2014
Safety and Effectiveness of a 2009 H1N1 Vaccine in Chronic Kidney Disease Children Osman Donmez a, b Okan Akaci a Nurhan Albayrak c Ayse Altas c Departments of a Pediatric Nephrology and b Rheumotalogy, School of Medicine, University of Uludag, Bursa, and c Refik Saydam National Public Health Agency, Unit of Virology, Ankara, Turkey
Key Words Child · Chronic kidney diseases · Dialysis · Influenza · Renal transplantation
Abstract Background/Aims: Influenza vaccination is the most effective method for preventing influenza infection and its complications. The risk groups are children with chronic kidney diseases (CKDs) such as children on peritoneal dialysis (PD) and hemodialysis (HD), predialysis CKD (pCKD) and renal transplant (RTx) patients and immunosuppressed children. The aim of the present study was to assess the safety and immunogenicity of a single administration of a monovalent inactivated pandemic (H1N1) 2009 vaccine in children with CKD. Methods: Patients were given a single intramuscular injection of 0.5 ml of monovalent inactivated vaccine. Results: Totally, there were 25 pediatric patients with a diagnosis of CKD (16 PD, 2 HD, 3 pCKD and 4 RTx). Seroconversion was observed in 15 of the 16 patients with PD. Seroconversion occurred in all patients undergoing pCKD and HD. However, 3 of the RTx patients were seronegative. Conclusion: This study demonstrated a high level of immunogenicity and safety of an (H1N1) 2009 influenza vaccine in children with CKD. © 2014 S. Karger AG, Basel
© 2014 S. Karger AG, Basel 1660–2110/14/1284–0341$39.50/0 E-Mail [email protected] www.karger.com/nec
Introduction
In April 2009, the emergence of swine flu caused an influenza pandemic in humans. Influenza infection causes serious morbidity and mortality. Most of the H1N1-infected people were children and young adults [1]. Influenza vaccination is the most effective method for preventing influenza infection and its complications. Infection rates of seasonal influenza were generally the highest in children, ranging from 25 to 43% [2]. Thus, the World Health Organization (WHO) recommends that vaccination efforts should initially focus on children who are at a higher risk for infections or related complications. According to these recommendations, attention should be paid to children with chronic kidney diseases (CKDs) such as children on peritoneal dialysis (PD) and hemodialysis (HD), predialysis CKD (pCKD) and renal transplant (RTx) patients and immunosuppressed children [3]. The morbidity and mortality associated with infectious diseases is very high in patients undergoing dialysis and renal transplantation [4]. In dialysis patients, the death rate from influenza (H1N1) was reported to be 5%, with the main cause of death being pneumonia [5]. Very few studies have been conducted to investigate the efficacy of influenza vaccination in children with Dr. Okan Akaci Department of Pediatric Nephrology School of Medicine, University of Uludag TR–16059 Görükle, Bursa (Turkey) E-Mail okanakaci @ gmail.com
chronic renal failure. The aim of this study was to assess the safety and immunogenicity of a single dose of a monovalent inactivated pandemic (H1N1) 2009 vaccine in children with CKD.
Materials and Methods Patients This study was performed between October and December 2009 at Uludag University Faculty of Medicine, Pediatric Nephrology and Rheumatology Unit, Bursa, Turkey. All subjects provided their written informed consent. The study design was approved by the local ethics committee. Totally, 25 pediatric patients with a diagnosis of CKD (16 PD, 2 HD, 3 pCKD and 4 RTx) and 18 children as a control group were included in this study. All children were older than 7 years. None of the patients had received vaccination against the 2009 H1N1 virus before. Those who had had a respiratory or febrile infection within the last month in their history, who developed a hypersensitivity reaction to vaccination and who were allergic to eggs were excluded from the study. All RTx patients were on a standard immunosuppression regimen (triple therapy; calcineurin inhibitors, mycophenolate sodium and prednisolone). Immunogenicity Assay – Hemagglutination Inhibition Assay A single intramuscular injection (deltoid muscle) of 0.5 ml influenza A (H1N1) 2009 monovalent inactivated vaccine (0.5 ml prefilled syringe; Sanofi-Pasteur®) was administered. The vaccine did not contain live virus particles. Before vaccination and 21 or 28 days after vaccination, serum samples were obtained from all patients. Serum aliquots were stored at –80 ° C in the deep-freezer until analyses at Virology Laboratories of Ankara Refik Saydam Hıfzıssıhha Institute took place. To measure antibody response against H1N1, a hemagglutination inhibition (HI) test was used. The HI assay presented the highest reciprocal dilution which induced complete HI. No antibody response means that the HI antibody titer is
