Kuter B J, Ngai A, Patterson C M, Staehle B O, Cho I, Matthews H, Provost P J, White C J
Merck Research Laboratories, West Point, PA, USA.
Vaccine. 1995 Aug;13(11):967-72. doi: 10.1016/0264-410x(95)00046-4.
A multicenter clinical trial was conducted among 757 healthy adolescents and adults, 13-54 years, to compare two regimens of Oka/Merck varicella vaccine with respect to safety, tolerability, and immunogenicity. Participants were randomized to receive two injections of vaccine either four or eight weeks apart and were followed for clinical reactions and serologic response. The two vaccine regimens were equally well tolerated. The seroconversion rates (gpELISA) four weeks after injection 1 and 2 were 72 and 99%, respectively, for those who received vaccine four weeks apart and 78 and 99%, respectively, for those who received vaccine eight weeks apart. The differences in seroconversion rates were not statistically significant. However, delaying the second dose to eight weeks resulted in a higher antibody titer one month after the second injection. Administration of a two-dose regimen of varicella vaccine to susceptible adolescents and adults is well tolerated and highly immunogenic.
在757名年龄在13至54岁的健康青少年和成年人中进行了一项多中心临床试验，以比较Oka/默克水痘疫苗的两种接种方案在安全性、耐受性和免疫原性方面的差异。参与者被随机分配接受间隔四周或八周的两次疫苗注射，并对临床反应和血清学反应进行随访。两种疫苗接种方案的耐受性同样良好。对于间隔四周接种疫苗的人，第一次和第二次注射四周后的血清转化率（gpELISA）分别为72%和99%；对于间隔八周接种疫苗的人，该转化率分别为78%和99%。血清转化率的差异无统计学意义。然而，将第二剂疫苗延迟至八周会导致第二次注射后一个月的抗体滴度更高。对易感青少年和成年人接种两剂次水痘疫苗耐受性良好且免疫原性高。
