Vaxinostics BV, University Vaccine Center Rotterdam Nijmegen, Rotterdam, The Netherlands.
Vaccine. 2011 May 17;29(22):3842-9. doi: 10.1016/j.vaccine.2011.02.067. Epub 2011 Mar 5.
The MMRV combination vaccine, Priorix-Tetra™, is currently licensed in several European countries using a two-dose schedule in infants aged ≥9 months, with a preferred 6-week to 3-month interval between doses. This study was undertaken to generate safety and immunogenicity data for two doses of MMRV vaccine administered according to dose schedules using the shortest permitted interval of 4 weeks versus a longer interval of 12 months, which would allow flexible adaptation to local immunization calendars.
Healthy children aged 11-13 months were randomized (1:1:1) to receive 2 doses of either: MMRV vaccine with a 4-week interval between doses (MMRV-4W group, N=188), MMRV vaccine with a 12-month interval between doses (MMRV-12M group, N=184), or MMR vaccine with a 4-week interval between doses (MMR group, N=187). Blood samples were taken prior to, and 4-6 weeks after each vaccination.
Post-Dose 2, both MMRV groups exhibited an adequate immunogenic response for all components; however the MMRV-12M group showed significantly greater geometric mean titers for mumps, rubella and varicella. Two varicella breakthrough cases occurred within the 12-month interval between doses in the MMRV-12M group. Local and general reactogenicity results were similar for all groups except for the MMRV-4W group, which had a greater incidence of fever during Days 0-14 post-Dose 1.
Two doses of MMRV vaccine administered in the second year of life elicited adequate immunogenicity and were well-tolerated whether administered with a dose interval of 4 weeks or 12 months.
MMRV 联合疫苗（Priorix-Tetra™）目前在几个欧洲国家获得许可，适用于≥9 月龄婴儿，采用两剂方案，两剂之间的最佳间隔为 6 周到 3 个月。本研究旨在评估按照最短间隔 4 周和较长间隔 12 个月（允许灵活适应当地免疫计划）接种两剂 MMRV 疫苗的安全性和免疫原性。
健康的 11-13 月龄儿童按 1:1:1 的比例随机分组，分别接受以下两种方案的 2 剂 MMRV 疫苗：两剂之间间隔 4 周（MMRV-4W 组，N=188）、两剂之间间隔 12 个月（MMRV-12M 组，N=184）或两剂之间间隔 4 周的 MMR 疫苗（MMR 组，N=187）。在每次接种前和接种后 4-6 周采集血样。
在接种第 2 剂后，MMRV 组均对所有成分产生了足够的免疫应答；然而，MMRV-12M 组的腮腺炎、风疹和水痘的几何平均滴度显著更高。在 MMRV-12M 组的 12 个月间隔期间，2 例水痘突破性病例发生。除 MMRV-4W 组外，所有组的局部和全身反应性结果相似，MMRV-4W 组在接种第 1 剂后第 0-14 天发热发生率更高。
在生命第二年接种两剂 MMRV 疫苗可产生足够的免疫原性，且无论接种间隔为 4 周还是 12 个月，均可耐受。
