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Koichi Kamei - One of the best experts on this subject based on the ideXlab platform.
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Live attenuated vaccines under Immunosuppressive Agents or biological Agents: survey and clinical data from Japan
European Journal of Pediatrics, 2021Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Mayumi Sako, Hidefumi NakamuraAbstract:Live attenuated vaccines are contraindicated for patients on Immunosuppressive Agents or biological agent, except for live attenuated varicella vaccine, although previous reports showed their effectiveness and safety. This study is the nationwide cross-sectional research about the current utilization of live attenuated vaccines for patients on Immunosuppressive Agents or biological Agents in Japan. We sent questionnaires to pediatric centers and examined whether each institution offered live attenuated vaccines to patients with Immunosuppressive Agents or biological Agents (institutional research). We also examined adverse events associated with live attenuated vaccines between 2013 and 2017 (patient research). In the institutional research, 46 out of 334 institutions (13.8%) administered live attenuated vaccines to patients receiving Immunosuppressive Agents. In contrast, only six out of 270 institutions (2.2%) administered live attenuated vaccines to patients receiving biological Agents. However, 66.3% of physicians answered that patients receiving Immunosuppressive Agents should be immunized with live attenuated vaccines, and only 7.0% disagreed with them. In the patient research, data for 781 patients were collected. Vaccine-associated infections were observed in only two patients (0.3%), both of whom had varicella, although they recovered promptly. No life-threatening adverse events were noted. Conclusion : In pediatric centers, the demand for live attenuated vaccines in patients receiving Immunosuppressive Agents was high and most physicians think they should be immunized. Immunization with live attenuated vaccines appeared safe in patients receiving Immunosuppressive Agents, although further studies are needed for patients receiving biological Agents What is known: • Live attenuated vaccines (LAV) are generally contraindicated for patients on Immunosuppressive Agents (IS) or biological Agents (BA), except for live attenuated varicella vaccine, as immunocompromised patients are at greater risk for serious viral infection from the vaccine strains. • Viral infections, such as measles and varicella, cause serious complications in children receiving IS. • Several previous reports showed that LAV is relatively effective and safe for patients receiving IS. What is new: • In Japan, the demand for LAV in patients receiving IS was high, and most physicians hoped they should be immunized. • Vaccine-associated infection is rarely observed in patients with IS after LAV administration. • Immunization with LAV appeared safe in patients receiving IS. Trial registration : University Hospital Medical Information Network (UMIN). Trial registration number : UMIN000029176. Date of registration : 2017/09/19.
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Prospective study of live attenuated vaccines for patients receiving Immunosuppressive Agents.
PloS one, 2020Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Reiko Ito, Shuichi ItoAbstract:Patients receiving Immunosuppressive Agents are at risk of life-threatening infections. However, live vaccines are generally contraindicated in them. We conducted a prospective study regarding live attenuated vaccines for them. Patients elder than one year of age with Immunosuppressive Agents who showed negative or borderline antibody titers (virus-specific IgG levels < 4.0) against one or more of measles, rubella, varicella, and mumps and fulfilled the criteria (CD4 cell counts ≥ 500/mm3, stimulation index of lymphocyte blast transformation by PHA ≥ 101.6, serum IgG level ≥ 300 mg/dl, no steroid use or prednisolone < 1 mg/kg/day or < 2 mg/kg/2 days, trough levels of tacrolimus or cyclosporine were < 10 ng/ml or < 100 ng/ml and under good control of primary disease) were enrolled. Sixty-four vaccinations were administered to 32 patients. The seroconversion rates for measles, rubella, varicella, and mumps were 80.0%, 100.0%, 59.1%, and 69.2%, respectively. No life-threatening adverse events were observed, although one patient suffered from vaccine-strain varicella who showed cellular and humoral immunodeficiency (CD4 cell counts = 511/mm3, stimulation index of lymphocyte blast transformation by PHA = 91.1, serum IgG level = 208 mg/dl). This girl was immunized before we established the criteria for vaccination. Immunization with live attenuated vaccines for patients receiving Immunosuppressive Agents might be effective and safe if their cellular and humoral immunological parameters are within normal levels. However, determining the criteria for vaccination by immunological parameters should be established to guarantee the safety of live vaccines in the future. Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000007710. The date of registration: 2012/4/13.
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Prospective Study of Live Attenuated Vaccines for Patients with Nephrotic Syndrome Receiving Immunosuppressive Agents.
The Journal of pediatrics, 2018Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Masao Ogura, Kenji Ishikura, Reiko Ito, Takanori Funaki, Jun Abe, Toshinao KawaiAbstract:To conduct a prospective study to evaluate the immunogenicity and safety of live attenuated vaccines in patients with nephrotic syndrome receiving Immunosuppressive Agents. Patients with nephrotic syndrome receiving Immunosuppressive Agents with negative or borderline antibody titers (virus-specific IgG levels <4.0) against measles, rubella, varicella, and/or mumps fulfilling the criteria of cellular and humoral immunity were enrolled. Virus-specific IgG levels were measured using an enzyme immunoassay. The primary endpoint was the seroconversion rate (ie, achievement of virus-specific IgG levels ≥4.0) at 2 months after vaccination. Virus-specific IgG levels at 1 year, breakthrough infections (wild-type infections), and adverse events were also evaluated. A total of 116 vaccinations were administered to 60 patients. Seroconversion rates were 95.7% for measles, 100% for rubella, 61.9% for varicella, and 40.0% for mumps. More patients with a borderline antibody titer before vaccination achieved seroconversion than those with negative antibody titer, with statistical significance after varicella and mumps vaccination. The rate of patients who maintained seropositivity at 1 year after vaccination was 83.3% for measles, 94.1% for rubella, 76.7% for varicella, and 20.0% for mumps. No patient experienced breakthrough infection. No serious adverse events, including vaccine-associated infection, were observed. Immunization with live attenuated vaccines may be immunogenic and is apparently safe in our cohort of patients with nephrotic syndrome receiving Immunosuppressive Agents if their cellular and humoral immunologic measures are within clinically acceptable levels. UMIN-CTR UMIN 000007710. Copyright © 2017 Elsevier Inc. All rights reserved.
Toshinao Kawai - One of the best experts on this subject based on the ideXlab platform.
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Live attenuated vaccines under Immunosuppressive Agents or biological Agents: survey and clinical data from Japan
European Journal of Pediatrics, 2021Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Mayumi Sako, Hidefumi NakamuraAbstract:Live attenuated vaccines are contraindicated for patients on Immunosuppressive Agents or biological agent, except for live attenuated varicella vaccine, although previous reports showed their effectiveness and safety. This study is the nationwide cross-sectional research about the current utilization of live attenuated vaccines for patients on Immunosuppressive Agents or biological Agents in Japan. We sent questionnaires to pediatric centers and examined whether each institution offered live attenuated vaccines to patients with Immunosuppressive Agents or biological Agents (institutional research). We also examined adverse events associated with live attenuated vaccines between 2013 and 2017 (patient research). In the institutional research, 46 out of 334 institutions (13.8%) administered live attenuated vaccines to patients receiving Immunosuppressive Agents. In contrast, only six out of 270 institutions (2.2%) administered live attenuated vaccines to patients receiving biological Agents. However, 66.3% of physicians answered that patients receiving Immunosuppressive Agents should be immunized with live attenuated vaccines, and only 7.0% disagreed with them. In the patient research, data for 781 patients were collected. Vaccine-associated infections were observed in only two patients (0.3%), both of whom had varicella, although they recovered promptly. No life-threatening adverse events were noted. Conclusion : In pediatric centers, the demand for live attenuated vaccines in patients receiving Immunosuppressive Agents was high and most physicians think they should be immunized. Immunization with live attenuated vaccines appeared safe in patients receiving Immunosuppressive Agents, although further studies are needed for patients receiving biological Agents What is known: • Live attenuated vaccines (LAV) are generally contraindicated for patients on Immunosuppressive Agents (IS) or biological Agents (BA), except for live attenuated varicella vaccine, as immunocompromised patients are at greater risk for serious viral infection from the vaccine strains. • Viral infections, such as measles and varicella, cause serious complications in children receiving IS. • Several previous reports showed that LAV is relatively effective and safe for patients receiving IS. What is new: • In Japan, the demand for LAV in patients receiving IS was high, and most physicians hoped they should be immunized. • Vaccine-associated infection is rarely observed in patients with IS after LAV administration. • Immunization with LAV appeared safe in patients receiving IS. Trial registration : University Hospital Medical Information Network (UMIN). Trial registration number : UMIN000029176. Date of registration : 2017/09/19.
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Prospective study of live attenuated vaccines for patients receiving Immunosuppressive Agents.
PloS one, 2020Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Reiko Ito, Shuichi ItoAbstract:Patients receiving Immunosuppressive Agents are at risk of life-threatening infections. However, live vaccines are generally contraindicated in them. We conducted a prospective study regarding live attenuated vaccines for them. Patients elder than one year of age with Immunosuppressive Agents who showed negative or borderline antibody titers (virus-specific IgG levels < 4.0) against one or more of measles, rubella, varicella, and mumps and fulfilled the criteria (CD4 cell counts ≥ 500/mm3, stimulation index of lymphocyte blast transformation by PHA ≥ 101.6, serum IgG level ≥ 300 mg/dl, no steroid use or prednisolone < 1 mg/kg/day or < 2 mg/kg/2 days, trough levels of tacrolimus or cyclosporine were < 10 ng/ml or < 100 ng/ml and under good control of primary disease) were enrolled. Sixty-four vaccinations were administered to 32 patients. The seroconversion rates for measles, rubella, varicella, and mumps were 80.0%, 100.0%, 59.1%, and 69.2%, respectively. No life-threatening adverse events were observed, although one patient suffered from vaccine-strain varicella who showed cellular and humoral immunodeficiency (CD4 cell counts = 511/mm3, stimulation index of lymphocyte blast transformation by PHA = 91.1, serum IgG level = 208 mg/dl). This girl was immunized before we established the criteria for vaccination. Immunization with live attenuated vaccines for patients receiving Immunosuppressive Agents might be effective and safe if their cellular and humoral immunological parameters are within normal levels. However, determining the criteria for vaccination by immunological parameters should be established to guarantee the safety of live vaccines in the future. Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000007710. The date of registration: 2012/4/13.
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Prospective Study of Live Attenuated Vaccines for Patients with Nephrotic Syndrome Receiving Immunosuppressive Agents.
The Journal of pediatrics, 2018Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Masao Ogura, Kenji Ishikura, Reiko Ito, Takanori Funaki, Jun Abe, Toshinao KawaiAbstract:To conduct a prospective study to evaluate the immunogenicity and safety of live attenuated vaccines in patients with nephrotic syndrome receiving Immunosuppressive Agents. Patients with nephrotic syndrome receiving Immunosuppressive Agents with negative or borderline antibody titers (virus-specific IgG levels <4.0) against measles, rubella, varicella, and/or mumps fulfilling the criteria of cellular and humoral immunity were enrolled. Virus-specific IgG levels were measured using an enzyme immunoassay. The primary endpoint was the seroconversion rate (ie, achievement of virus-specific IgG levels ≥4.0) at 2 months after vaccination. Virus-specific IgG levels at 1 year, breakthrough infections (wild-type infections), and adverse events were also evaluated. A total of 116 vaccinations were administered to 60 patients. Seroconversion rates were 95.7% for measles, 100% for rubella, 61.9% for varicella, and 40.0% for mumps. More patients with a borderline antibody titer before vaccination achieved seroconversion than those with negative antibody titer, with statistical significance after varicella and mumps vaccination. The rate of patients who maintained seropositivity at 1 year after vaccination was 83.3% for measles, 94.1% for rubella, 76.7% for varicella, and 20.0% for mumps. No patient experienced breakthrough infection. No serious adverse events, including vaccine-associated infection, were observed. Immunization with live attenuated vaccines may be immunogenic and is apparently safe in our cohort of patients with nephrotic syndrome receiving Immunosuppressive Agents if their cellular and humoral immunologic measures are within clinically acceptable levels. UMIN-CTR UMIN 000007710. Copyright © 2017 Elsevier Inc. All rights reserved.
Antoine Blancher - One of the best experts on this subject based on the ideXlab platform.
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QuantiFERON test interpretation in patients receiving Immunosuppressive Agents: an alert.
European Respiratory Journal, 2017Co-Authors: Julie Belliere, Antoine BlancherAbstract:Caution to patients with negative QuantiFERON and low mitogen response receiving Immunosuppressive Agents http://ow.ly/MKsP308O3jo
Kenji Ishikura - One of the best experts on this subject based on the ideXlab platform.
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Live attenuated vaccines under Immunosuppressive Agents or biological Agents: survey and clinical data from Japan
European Journal of Pediatrics, 2021Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Mayumi Sako, Hidefumi NakamuraAbstract:Live attenuated vaccines are contraindicated for patients on Immunosuppressive Agents or biological agent, except for live attenuated varicella vaccine, although previous reports showed their effectiveness and safety. This study is the nationwide cross-sectional research about the current utilization of live attenuated vaccines for patients on Immunosuppressive Agents or biological Agents in Japan. We sent questionnaires to pediatric centers and examined whether each institution offered live attenuated vaccines to patients with Immunosuppressive Agents or biological Agents (institutional research). We also examined adverse events associated with live attenuated vaccines between 2013 and 2017 (patient research). In the institutional research, 46 out of 334 institutions (13.8%) administered live attenuated vaccines to patients receiving Immunosuppressive Agents. In contrast, only six out of 270 institutions (2.2%) administered live attenuated vaccines to patients receiving biological Agents. However, 66.3% of physicians answered that patients receiving Immunosuppressive Agents should be immunized with live attenuated vaccines, and only 7.0% disagreed with them. In the patient research, data for 781 patients were collected. Vaccine-associated infections were observed in only two patients (0.3%), both of whom had varicella, although they recovered promptly. No life-threatening adverse events were noted. Conclusion : In pediatric centers, the demand for live attenuated vaccines in patients receiving Immunosuppressive Agents was high and most physicians think they should be immunized. Immunization with live attenuated vaccines appeared safe in patients receiving Immunosuppressive Agents, although further studies are needed for patients receiving biological Agents What is known: • Live attenuated vaccines (LAV) are generally contraindicated for patients on Immunosuppressive Agents (IS) or biological Agents (BA), except for live attenuated varicella vaccine, as immunocompromised patients are at greater risk for serious viral infection from the vaccine strains. • Viral infections, such as measles and varicella, cause serious complications in children receiving IS. • Several previous reports showed that LAV is relatively effective and safe for patients receiving IS. What is new: • In Japan, the demand for LAV in patients receiving IS was high, and most physicians hoped they should be immunized. • Vaccine-associated infection is rarely observed in patients with IS after LAV administration. • Immunization with LAV appeared safe in patients receiving IS. Trial registration : University Hospital Medical Information Network (UMIN). Trial registration number : UMIN000029176. Date of registration : 2017/09/19.
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Prospective study of live attenuated vaccines for patients receiving Immunosuppressive Agents.
PloS one, 2020Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Reiko Ito, Shuichi ItoAbstract:Patients receiving Immunosuppressive Agents are at risk of life-threatening infections. However, live vaccines are generally contraindicated in them. We conducted a prospective study regarding live attenuated vaccines for them. Patients elder than one year of age with Immunosuppressive Agents who showed negative or borderline antibody titers (virus-specific IgG levels < 4.0) against one or more of measles, rubella, varicella, and mumps and fulfilled the criteria (CD4 cell counts ≥ 500/mm3, stimulation index of lymphocyte blast transformation by PHA ≥ 101.6, serum IgG level ≥ 300 mg/dl, no steroid use or prednisolone < 1 mg/kg/day or < 2 mg/kg/2 days, trough levels of tacrolimus or cyclosporine were < 10 ng/ml or < 100 ng/ml and under good control of primary disease) were enrolled. Sixty-four vaccinations were administered to 32 patients. The seroconversion rates for measles, rubella, varicella, and mumps were 80.0%, 100.0%, 59.1%, and 69.2%, respectively. No life-threatening adverse events were observed, although one patient suffered from vaccine-strain varicella who showed cellular and humoral immunodeficiency (CD4 cell counts = 511/mm3, stimulation index of lymphocyte blast transformation by PHA = 91.1, serum IgG level = 208 mg/dl). This girl was immunized before we established the criteria for vaccination. Immunization with live attenuated vaccines for patients receiving Immunosuppressive Agents might be effective and safe if their cellular and humoral immunological parameters are within normal levels. However, determining the criteria for vaccination by immunological parameters should be established to guarantee the safety of live vaccines in the future. Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000007710. The date of registration: 2012/4/13.
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Prospective Study of Live Attenuated Vaccines for Patients with Nephrotic Syndrome Receiving Immunosuppressive Agents.
The Journal of pediatrics, 2018Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Masao Ogura, Kenji Ishikura, Reiko Ito, Takanori Funaki, Jun Abe, Toshinao KawaiAbstract:To conduct a prospective study to evaluate the immunogenicity and safety of live attenuated vaccines in patients with nephrotic syndrome receiving Immunosuppressive Agents. Patients with nephrotic syndrome receiving Immunosuppressive Agents with negative or borderline antibody titers (virus-specific IgG levels <4.0) against measles, rubella, varicella, and/or mumps fulfilling the criteria of cellular and humoral immunity were enrolled. Virus-specific IgG levels were measured using an enzyme immunoassay. The primary endpoint was the seroconversion rate (ie, achievement of virus-specific IgG levels ≥4.0) at 2 months after vaccination. Virus-specific IgG levels at 1 year, breakthrough infections (wild-type infections), and adverse events were also evaluated. A total of 116 vaccinations were administered to 60 patients. Seroconversion rates were 95.7% for measles, 100% for rubella, 61.9% for varicella, and 40.0% for mumps. More patients with a borderline antibody titer before vaccination achieved seroconversion than those with negative antibody titer, with statistical significance after varicella and mumps vaccination. The rate of patients who maintained seropositivity at 1 year after vaccination was 83.3% for measles, 94.1% for rubella, 76.7% for varicella, and 20.0% for mumps. No patient experienced breakthrough infection. No serious adverse events, including vaccine-associated infection, were observed. Immunization with live attenuated vaccines may be immunogenic and is apparently safe in our cohort of patients with nephrotic syndrome receiving Immunosuppressive Agents if their cellular and humoral immunologic measures are within clinically acceptable levels. UMIN-CTR UMIN 000007710. Copyright © 2017 Elsevier Inc. All rights reserved.
Masao Ogura - One of the best experts on this subject based on the ideXlab platform.
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Live attenuated vaccines under Immunosuppressive Agents or biological Agents: survey and clinical data from Japan
European Journal of Pediatrics, 2021Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Mayumi Sako, Hidefumi NakamuraAbstract:Live attenuated vaccines are contraindicated for patients on Immunosuppressive Agents or biological agent, except for live attenuated varicella vaccine, although previous reports showed their effectiveness and safety. This study is the nationwide cross-sectional research about the current utilization of live attenuated vaccines for patients on Immunosuppressive Agents or biological Agents in Japan. We sent questionnaires to pediatric centers and examined whether each institution offered live attenuated vaccines to patients with Immunosuppressive Agents or biological Agents (institutional research). We also examined adverse events associated with live attenuated vaccines between 2013 and 2017 (patient research). In the institutional research, 46 out of 334 institutions (13.8%) administered live attenuated vaccines to patients receiving Immunosuppressive Agents. In contrast, only six out of 270 institutions (2.2%) administered live attenuated vaccines to patients receiving biological Agents. However, 66.3% of physicians answered that patients receiving Immunosuppressive Agents should be immunized with live attenuated vaccines, and only 7.0% disagreed with them. In the patient research, data for 781 patients were collected. Vaccine-associated infections were observed in only two patients (0.3%), both of whom had varicella, although they recovered promptly. No life-threatening adverse events were noted. Conclusion : In pediatric centers, the demand for live attenuated vaccines in patients receiving Immunosuppressive Agents was high and most physicians think they should be immunized. Immunization with live attenuated vaccines appeared safe in patients receiving Immunosuppressive Agents, although further studies are needed for patients receiving biological Agents What is known: • Live attenuated vaccines (LAV) are generally contraindicated for patients on Immunosuppressive Agents (IS) or biological Agents (BA), except for live attenuated varicella vaccine, as immunocompromised patients are at greater risk for serious viral infection from the vaccine strains. • Viral infections, such as measles and varicella, cause serious complications in children receiving IS. • Several previous reports showed that LAV is relatively effective and safe for patients receiving IS. What is new: • In Japan, the demand for LAV in patients receiving IS was high, and most physicians hoped they should be immunized. • Vaccine-associated infection is rarely observed in patients with IS after LAV administration. • Immunization with LAV appeared safe in patients receiving IS. Trial registration : University Hospital Medical Information Network (UMIN). Trial registration number : UMIN000029176. Date of registration : 2017/09/19.
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Prospective study of live attenuated vaccines for patients receiving Immunosuppressive Agents.
PloS one, 2020Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Toshinao Kawai, Masao Ogura, Kenji Ishikura, Reiko Ito, Shuichi ItoAbstract:Patients receiving Immunosuppressive Agents are at risk of life-threatening infections. However, live vaccines are generally contraindicated in them. We conducted a prospective study regarding live attenuated vaccines for them. Patients elder than one year of age with Immunosuppressive Agents who showed negative or borderline antibody titers (virus-specific IgG levels < 4.0) against one or more of measles, rubella, varicella, and mumps and fulfilled the criteria (CD4 cell counts ≥ 500/mm3, stimulation index of lymphocyte blast transformation by PHA ≥ 101.6, serum IgG level ≥ 300 mg/dl, no steroid use or prednisolone < 1 mg/kg/day or < 2 mg/kg/2 days, trough levels of tacrolimus or cyclosporine were < 10 ng/ml or < 100 ng/ml and under good control of primary disease) were enrolled. Sixty-four vaccinations were administered to 32 patients. The seroconversion rates for measles, rubella, varicella, and mumps were 80.0%, 100.0%, 59.1%, and 69.2%, respectively. No life-threatening adverse events were observed, although one patient suffered from vaccine-strain varicella who showed cellular and humoral immunodeficiency (CD4 cell counts = 511/mm3, stimulation index of lymphocyte blast transformation by PHA = 91.1, serum IgG level = 208 mg/dl). This girl was immunized before we established the criteria for vaccination. Immunization with live attenuated vaccines for patients receiving Immunosuppressive Agents might be effective and safe if their cellular and humoral immunological parameters are within normal levels. However, determining the criteria for vaccination by immunological parameters should be established to guarantee the safety of live vaccines in the future. Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) UMIN000007710. The date of registration: 2012/4/13.
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Prospective Study of Live Attenuated Vaccines for Patients with Nephrotic Syndrome Receiving Immunosuppressive Agents.
The Journal of pediatrics, 2018Co-Authors: Koichi Kamei, Isao Miyairi, Kensuke Shoji, Katsuhiro Arai, Masao Ogura, Kenji Ishikura, Reiko Ito, Takanori Funaki, Jun Abe, Toshinao KawaiAbstract:To conduct a prospective study to evaluate the immunogenicity and safety of live attenuated vaccines in patients with nephrotic syndrome receiving Immunosuppressive Agents. Patients with nephrotic syndrome receiving Immunosuppressive Agents with negative or borderline antibody titers (virus-specific IgG levels <4.0) against measles, rubella, varicella, and/or mumps fulfilling the criteria of cellular and humoral immunity were enrolled. Virus-specific IgG levels were measured using an enzyme immunoassay. The primary endpoint was the seroconversion rate (ie, achievement of virus-specific IgG levels ≥4.0) at 2 months after vaccination. Virus-specific IgG levels at 1 year, breakthrough infections (wild-type infections), and adverse events were also evaluated. A total of 116 vaccinations were administered to 60 patients. Seroconversion rates were 95.7% for measles, 100% for rubella, 61.9% for varicella, and 40.0% for mumps. More patients with a borderline antibody titer before vaccination achieved seroconversion than those with negative antibody titer, with statistical significance after varicella and mumps vaccination. The rate of patients who maintained seropositivity at 1 year after vaccination was 83.3% for measles, 94.1% for rubella, 76.7% for varicella, and 20.0% for mumps. No patient experienced breakthrough infection. No serious adverse events, including vaccine-associated infection, were observed. Immunization with live attenuated vaccines may be immunogenic and is apparently safe in our cohort of patients with nephrotic syndrome receiving Immunosuppressive Agents if their cellular and humoral immunologic measures are within clinically acceptable levels. UMIN-CTR UMIN 000007710. Copyright © 2017 Elsevier Inc. All rights reserved.
