Division of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.
Division of Infectious Diseases, National Center for Child Health and Development, Tokyo, Japan.
J Pediatr. 2018 May;196:217-222.e1. doi: 10.1016/j.jpeds.2017.12.061. Epub 2018 Feb 28.
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.
前瞻性研究评估肾病综合征患者接受免疫抑制剂治疗时，减毒活疫苗的免疫原性和安全性。
符合细胞和体液免疫标准的肾病综合征患者接受免疫抑制剂治疗，其麻疹、风疹、水痘和/或腮腺炎抗体滴度阴性或临界（病毒特异性 IgG 水平＜4.0）纳入研究。采用酶联免疫吸附试验检测病毒特异性 IgG 水平。主要终点为接种后 2 个月的血清转化率（即病毒特异性 IgG 水平≥4.0）。还评估了病毒特异性 IgG 水平在 1 年时、突破性感染（野生型感染）和不良事件。
共为 60 例患者接种了 116 剂疫苗。麻疹、风疹、水痘和腮腺炎的血清转化率分别为 95.7%、100%、61.9%和 40.0%。接种前抗体滴度临界的患者比抗体滴度阴性的患者更易实现血清转化率，接种水痘和腮腺炎疫苗时具有统计学意义。接种后 1 年时，保持血清阳性的患者比例分别为麻疹 83.3%、风疹 94.1%、水痘 76.7%和腮腺炎 20.0%。无患者发生突破性感染。未观察到与疫苗相关的感染等严重不良事件。
如果肾病综合征患者接受免疫抑制剂治疗时细胞和体液免疫指标处于临床可接受水平，接种减毒活疫苗可能具有免疫原性，且明显安全。
UMIN-CTR UMIN 000007710。
