Sperber S J, Smith B V, Hayden F G
Department of Internal Medicine, University of Virginia School of Medicine, Charlottesville 22908.
Antiviral Res. 1992 Mar;17(3):213-22. doi: 10.1016/0166-3542(92)90042-4.
The immunogenicity and reactogenicity of live and heat-inactivated varicella vaccine were evaluated in 95 healthy seropositive adults (mean age, 32 yrs). Live-attenuated vaccine containing 28,000 pfu, 2800 pfu, or 280 pfu of Oka/Merck strain virus (8.4, 0.84, and 0.08 antigen units, respectively) or heat-inactivated vaccine with comparable antigen content (7.1, 0.71, and 0.07 antigen units) was administered subcutaneously to 15 to 16 adults per group in a randomized, single-blind study. ELISA antibody responses were dose-dependent but independent of whether the vaccine was live or inactivated. Mean titers reached a peak on day 14 and remained elevated through day 42 in recipients of the highest dosages but declined by followup at eleven months. A minority of vaccinees developed a four-fold or greater increase in antibody titer on day 14 (25 to 31 percent in the high-dose groups [greater than or equal to 7.1 antigen units], less than or equal to 7 percent of other groups). The vaccine was generally well tolerated. Localized erythema and swelling occurred at the injection site in 44 to 56 percent of the high- and middle dose recipients [greater than or equal to 0.71 antigen units], compared with 0 to 6 percent of those receiving the lowest dose. Although statistically significant increases in varicella antibody titer were observed after immunization with high doses of live or inactivated vaccine, the duration and clinical significance of this booster effect remains to be determined.
在95名健康的血清阳性成年人(平均年龄32岁)中评估了活的和热灭活水痘疫苗的免疫原性和反应原性。将含有28,000 pfu、2800 pfu或280 pfu Oka/Merck株病毒(分别为8.4、0.84和0.08抗原单位)的减毒活疫苗或具有相当抗原含量(7.1、0.71和0.07抗原单位)的热灭活疫苗,以随机、单盲研究的方式皮下注射给每组15至16名成年人。ELISA抗体反应呈剂量依赖性,但与疫苗是活的还是灭活的无关。最高剂量组的接受者平均滴度在第14天达到峰值,并在第42天之前一直保持升高,但在11个月的随访中下降。少数接种者在第14天抗体滴度增加了四倍或更多(高剂量组[大于或等于7.1抗原单位]中为25%至31%,其他组中小于或等于7%)。该疫苗总体耐受性良好。高剂量和中剂量接受者(大于或等于0.71抗原单位)中有44%至56%在注射部位出现局部红斑和肿胀,而接受最低剂量者中这一比例为0%至6%。虽然在高剂量活疫苗或灭活疫苗免疫后观察到水痘抗体滴度有统计学显著升高,但这种加强作用的持续时间和临床意义仍有待确定。