Clinical Research Support Center, Tokyo Metropolitan Children's Medical Center, 2-8-29 Musashidai, Fuchu, Tokyo 183-8561, Japan.
Department of General Pediatrics, Tokyo Metropolitan Children's Medical Center, 2-8-29 Musashidai, Fuchu, Tokyo 183-8561, Japan.
Vaccine. 2021 Sep 15;39(39):5680-5687. doi: 10.1016/j.vaccine.2021.07.097. Epub 2021 Aug 25.
Due to the presence of maternal passive antibodies, the measles vaccine is ineffective if administered before age 12-15 months. The optimal timing for administering a live attenuated vaccine (LAV) after intravenous immunoglobulin therapy (IVIG) for Kawasaki disease (KD) has not been fully investigated. The recommended interval between vaccination and IVIG therapy for KD differs by country. The present study aimed to evaluate efficacy of LAV six months after IVIG therapy for KD in Japan.
The present, single-arm, prospective, interventional study included patients aged 6 months or older with no medical history of measles, rubella, varicella or mumps or vaccinations against these diseases. The subjects received these vaccinations for the first time at six months after IVIG therapy. Virus-specific IgG levels for each virus measured by EIA was examined at nine months after IVIG therapy. If the results were negative, the subjects received a booster vaccination at 12 months after IVIG therapy. The primary outcome was the prevalence of positivity for antibodies after the initial and booster vaccinations.
The present study enrolled 32 subjects, 31% of whom were female, with an average age of 10.8 (standard deviation 2.8) months at IVIG therapy. At six months after IVIG therapy, 9% and 6% of the subjects were seropositive for measles and varicella titers, respectively, but were seronegative for the mumps and rubella titers. The seroconversion rate for measles, mumps, rubella, and varicella after the initial vaccination was 88%, 6%, 78%, and 16%, respectively. The seroconversion rate after a booster vaccination was 100% for measles and rubella, 97% for mumps, and 77% for varicella.
The seroconversion rate was low for LAV at six months after a single dose of IVIG for KD, but seroconversion was achievable with a booster vaccination at 12 months.
UMIN-CTR, UMIN000007174, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008452.
由于母体被动抗体的存在，如果在 12-15 个月之前给予麻疹疫苗，疫苗将无效。对于接受静脉注射免疫球蛋白（IVIG）治疗后的川崎病（KD），何时最佳给予减毒活疫苗（LAV）尚未得到充分研究。不同国家对 KD 患者接种疫苗和 IVIG 治疗之间的推荐间隔时间有所不同。本研究旨在评估日本 KD 患者在 IVIG 治疗后 6 个月给予 LAV 的疗效。
本研究为单臂、前瞻性、干预性研究，纳入年龄在 6 个月或以上、无麻疹、风疹、水痘或腮腺炎病史或未接种过这些疾病疫苗的患者。这些患者在 IVIG 治疗后 6 个月首次接受这些疫苗接种。在 IVIG 治疗后 9 个月，通过 EIA 检测每种病毒的病毒特异性 IgG 水平。如果结果为阴性，患者在 IVIG 治疗后 12 个月接受加强免疫接种。主要结局是初次和加强免疫接种后的抗体阳性率。
本研究共纳入 32 名患者，其中 31%为女性，IVIG 治疗时的平均年龄为 10.8（标准差 2.8）个月。在 IVIG 治疗后 6 个月，9%和 6%的患者麻疹和水痘滴度呈阳性，但腮腺炎和风疹滴度呈阴性。初次接种后麻疹、腮腺炎、风疹和水痘的血清转化率分别为 88%、6%、78%和 16%。加强免疫接种后的血清转化率为麻疹和风疹 100%、腮腺炎 97%、水痘 77%。
KD 患者单次 IVIG 治疗后 6 个月 LAV 的血清转化率较低，但在 12 个月时加强免疫接种可实现血清转化率。
UMIN-CTR，UMIN000007174，https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008452。
