Gillet Y, Steri G C, Behre U, Arsène J P, Lanse X, Helm K, Esposito S, Meister N, Desole M G, Douha M, Willems P
Hôpital Femme Mère Enfant, Urgences Pédiatriques Lyon France, 59 Bd Pinel, 69500 BRON, France.
Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.
In this open, randomized, comparative study (105908/NCT00353288), 458 age-stratified children (15 months-2 years and 2-6 years) previously primed with MMR received one dose of either a combined MMRV vaccine (Priorix-Tetra, MMRV group) or concomitant MMR and varicella vaccines (Priorix and Varilrix, MMR+V group), followed 42-56 days later by another dose of varicella vaccine (Varilrix) in both groups. Post-vaccination measles, mumps and rubella seropositivity rates and antibody geometric mean titers (GMTs) were high (99.5% for anti-measles and 100% for anti-mumps and anti-rubella) in both vaccine groups. In the two age strata, varicella seroconversion rates were, post-dose 1: > or =97.6% (MMRV), > or =96.6% (MMR+V) and, post-dose 2: 100% in both groups. Post-dose 2, anti-varicella GMTs increased respectively 14.1- and 12.6-fold (MMRV), and 9.8- and 13.1-fold (MMR+V). Both vaccine regimens were well-tolerated. Post-dose 1, the incidence of any solicited local symptom during the 4-days follow-up was < or =28.2% (MMRV) and < or =19.8% (MMR+V) and the incidence of fever >39.5 degrees C (rectal temperature) within 15 days was < or =2.8% (MMRV) and < or =2.6% (MMR+V). This MMRV vaccine appears an immunogenic and safe substitute for a second dose of MMR vaccine in young children. The increase in anti-varicella antibodies observed after a second dose of varicella vaccine supports a two-dose schedule for varicella-containing vaccine.
在这项开放性、随机、对照研究（105908/NCT00353288）中，458名按年龄分层的儿童（15个月至2岁以及2至6岁）之前已接种过MMR疫苗，他们分别接种一剂联合MMRV疫苗（Priorix-Tetra，MMRV组）或同时接种MMR疫苗和水痘疫苗（Priorix和Varilrix，MMR+V组），42至56天后两组均再接种一剂水痘疫苗（Varilrix）。接种疫苗后，两组的麻疹、腮腺炎和风疹血清阳性率及抗体几何平均滴度（GMT）均较高（抗麻疹为99.5%，抗腮腺炎和抗风疹为100%）。在两个年龄层中，第1剂接种后水痘血清转化率为：MMRV组≥97.6%，MMR+V组≥96.6%；第2剂接种后两组均为100%。第2剂接种后，抗水痘GMT分别升高了14.1倍和12.6倍（MMRV组），以及9.8倍和13.1倍（MMR+V组）。两种疫苗接种方案耐受性均良好。第1剂接种后，4天随访期间任何主动报告的局部症状发生率为：MMRV组≤28.2%，MMR+V组≤19.8%；15天内体温>39.5℃（直肠温度）的发生率为：MMRV组≤2.8%，MMR+V组≤2.6%。这种MMRV疫苗似乎是幼儿第二剂MMR疫苗的一种具有免疫原性且安全的替代疫苗。接种第二剂水痘疫苗后观察到的抗水痘抗体增加支持了含水痘疫苗的两剂接种程序。
