Ngai A L, Staehle B O, Kuter B J, Cyanovich N M, Cho I, Matthews H, Keller P, Arvin A M, Watson B, White C J
Merck Research Laboratories, West Point, PA, USA.
Pediatr Infect Dis J. 1996 Jan;15(1):49-54. doi: 10.1097/00006454-199601000-00011.
To compare the safety and immunogenicity of a one- vs. two-dose regimen of Oka/Merck varicella vaccine in approximately 2000 healthy children 12 months to 12 years of age.
Subjects with a negative history of varicella were randomized to receive either one or two injections of the vaccine given 3 months apart and were followed for clinical reactions and serologic response (glycoprotein-based enzyme-linked immunosorbent assay).
Both one- and two-dose vaccine regimens were generally well-tolerated. The incidences of varicelliform rash and fever were less frequent after the second injection. However, a slight increase in the incidence of injection site reactions was noted after the second injection; these were generally mild. Seroconversion rates by glycoprotein-based enzyme-linked immunosorbent assay were 98.2% (1700 of 1731) after one injection and 99.9% (717 of 718) after two injections. A significant (P < 0.001) boost in geometric mean titers was observed in children who received a second injection of vaccine 3 months after the first injection. Of the children who seroconverted at 6 weeks postregimen (one or two doses as assigned), 99.8% (528 of 529) of the one-dose group and 99.8% (473 of 474) of the two-dose group maintained antibody to varicella at 1 year with geometric mean titers of 19.5 and 31.2, respectively.
Administration of a one- or two-dose regimen of the live Oka/Merck varicella vaccine (VARIVAX) is immunogenic and is generally well-tolerated in healthy children 1 to 12 years old. Antibody to varicella persists in > 99% of vaccinees 1 year after vaccination regardless of a one- or two-dose regimen. Long-term follow-up studies of this cohort of children may determine whether a two-dose regimen offers superior protection against chickenpox.
比较单剂量与双剂量Oka/默克水痘疫苗接种方案在约2000名12个月至12岁健康儿童中的安全性和免疫原性。
水痘病史阴性的受试者被随机分为两组，分别接受间隔3个月的单剂或双剂疫苗注射，并对临床反应和血清学反应（基于糖蛋白的酶联免疫吸附测定）进行随访。
单剂量和双剂量疫苗接种方案总体耐受性良好。第二次注射后水痘样皮疹和发热的发生率较低。然而，第二次注射后注射部位反应的发生率略有增加；这些反应通常较轻。基于糖蛋白的酶联免疫吸附测定的血清转化率在单剂注射后为98.2%（1731例中的1700例），双剂注射后为99.9%（718例中的717例）。在首次注射疫苗3个月后接受第二次注射的儿童中，观察到几何平均滴度有显著提高（P<0.001）。在方案实施后6周血清转化的儿童中（按分配接受单剂或双剂），单剂组99.8%（529例中的528例）和双剂组99.8%（474例中的473例）在1年时维持对水痘的抗体，几何平均滴度分别为19.5和31.2。
接种单剂量或双剂量的活Oka/默克水痘疫苗（VARIVAX）具有免疫原性，在1至12岁的健康儿童中总体耐受性良好。无论单剂量还是双剂量接种方案，接种疫苗1年后超过99%的接种者体内仍有水痘抗体。对这组儿童的长期随访研究可能会确定双剂量接种方案是否能提供更好的水痘防护。
