Greenberg D P, Ward J I, Burkart K, Christenson P D, Guravitz L, Marcy S M
Pediatr Infect Dis J. 1987 Jul;6(7):660-5. doi: 10.1097/00006454-198707000-00008.
The purpose of this study was to evaluate differences in the safety and immunogenicity of Haemophilus influenzae type b (Hib) capsular polysaccharide vaccine produced by two manufacturers (Connaught and Praxis) in children 18 and 24 months of age. Eighty-five children were evaluated in a prospective, double-blind, randomized fashion. Postvaccination antibody concentrations (measured by radioimmunoassay) and response rates were not significantly different between the two manufacturers' vaccines but immunogenicity was significantly less in 18-month-old children (antibody concentration, 0.149 microgram/ml) compared with 24-month-old children (0.838 microgram/ml) (P = 0.001). No significant differences were noted in the safety of the two vaccines. This study suggests that previously observed differences of immunogenicity data between various type b capsular polysaccharide vaccines are due to differences in antibody assays, not in vaccines. Eighteen-month-old children appear to have a relatively poor immune response to type b capsular polysaccharide. Therefore to optimize the benefits of immunization, we suggest children receive this vaccine at 24 months of age.
本研究的目的是评估由两家制造商（康诺特和普 Praxis）生产的 b 型流感嗜血杆菌（Hib）荚膜多糖疫苗在 18 个月和 24 个月大儿童中的安全性和免疫原性差异。85 名儿童以前瞻性、双盲、随机方式接受评估。两种制造商疫苗接种后的抗体浓度（通过放射免疫测定法测量）和应答率无显著差异，但 18 个月大儿童（抗体浓度为 0.149 微克/毫升）的免疫原性明显低于 24 个月大儿童（0.838 微克/毫升）（P = 0.001）。两种疫苗的安全性未发现显著差异。本研究表明，先前观察到的各种 b 型荚膜多糖疫苗之间免疫原性数据的差异是由于抗体检测方法的不同，而非疫苗本身的差异。18 个月大的儿童对 b 型荚膜多糖的免疫应答似乎相对较差。因此，为了优化免疫接种的益处，我们建议儿童在 24 个月大时接种该疫苗。
