Charles University, Faculty of Medicine, Hradec Kralove, Czech Republic.
GSK, Wavre, Belgium.
Vaccine. 2021 May 6;39(19):2643-2651. doi: 10.1016/j.vaccine.2021.03.085. Epub 2021 Apr 12.
We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia.
This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded.
A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified.
Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.
我们评估了两剂麻疹-腮腺炎-风疹-水痘联合疫苗（MMRV）或一剂单价水痘疫苗（V）在捷克共和国、立陶宛、波兰、罗马尼亚和斯洛伐克儿童中的 10 年疗效、免疫原性和安全性。
这是一项 IIIB 期随访观察、盲法、随机对照试验（NCT00226499）。在 A 阶段，来自 10 个欧洲国家的 12-22 月龄健康儿童以 3:3:1 的比例随机分为三组，分别接受两剂 MMRV（MMRV 组）、一剂 MMR 后一剂 V（MMR+V 组）或两剂 MMR（MMR 组），间隔 42 天。采用 Cox 比例风险回归模型计算水痘（通过病毒 DNA 检测或流行病学关联和临床评估证实）的疫苗效力（VE），置信区间为 95%。免疫原性通过血清阳性率和几何平均浓度（GMC）评估。记录了不良事件（AE）和严重不良事件（SAE）。
共 3705 名儿童接种疫苗（MMRV 组 1590 名，MMR+V 组 1586 名，MMR 组 529 名）。共有 663 例水痘确诊病例（MMRV 组 47 例，MMR+V 组 349 例，MMR 组 267 例）。MMRV 组 VE 范围为 95.4%（立陶宛）至 97.4%（斯洛伐克），MMR+V 组 VE 范围为 59.3%（立陶宛）至 74%（斯洛伐克）。第 10 年时，MMRV 组血清阳性率为 99.5%-100%，MMR+V 组为 98%-100%，MMR 组为 50%-100%，MMRV 组和 MMR+V 组的抗 VZV 抗体 GMC 相当。各组报告的不良反应发生率相似，无任何 SAE 被认为与疫苗接种相关。未发现新的安全性问题。
我们的结果表明，水痘带状疱疹病毒含量疫苗两剂接种比一剂接种能更好地预防水痘，且诱导的抗体反应在接种后 10 年仍持续存在。
