Holmes S J, Fritzell B, Guito K P, Esbenshade J F, Blatter M M, Reisinger K S, Keyserling H L, Rothstein E P, Bernstein H H, Feldman S
Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine, St Louis, Mo 63110.
Am J Dis Child. 1993 Aug;147(8):832-6. doi: 10.1001/archpedi.1993.02160320034015.
To compare the safety and immunogenicity of three investigational lots of Haemophilus influenzae type b polysaccharide-tetanus toxoid (PRP-T) conjugate vaccine in infants.
A multicenter, randomized immunogenicity trial. Infants were vaccinated at 2, 4, and 6 months of age with one of three lots of PRP-T. A control group received H influenzae type b oligomers conjugated to CRM197 (HbOC). Serum was obtained before each injection and 1 month after the third dose, and assayed blindly for antibody in one laboratory.
Four hundred eighty-four infants from private pediatric practices located in five geographic areas.
There were no significant differences in the number of adverse events reported for infants receiving PRP-T or HbOC, and the rates did not exceed those observed previously in infants given diphtheria-tetanus-pertussis vaccine alone. Total serum anti-PRP antibody responses were analyzed in 336 infants who met strict inclusion criteria. After one, two, or three doses, the respective antibody responses to each of the three lots of PRP-T and to HbOC vaccine were similar. The only exception was one lot of PRP-T, which after one or two injections elicited significantly higher geometric mean antibody responses than the other two lots or the HbOC vaccine. After a third injection, there were no significant lot differences. Combining the data from the different lots, there were no significant differences in the geometric mean antibody concentration after three doses of PRP-T or HbOC (8.3 vs 7.7 micrograms/mL), and 95% and 91%, respectively, of infants had greater than 1.0 microgram/mL of antibody. There were no significant differences in the magnitudes of the respective IgG1-, IgG2-, and IgM-specific antibody concentrations between infants given PRP-T or HbOC.
The three investigational lots of PRP-T tested were safe and were as immunogenic as or more so than the licensed HbOC conjugate vaccine.
比较三种研究用b型流感嗜血杆菌多糖-破伤风类毒素（PRP-T）结合疫苗在婴儿中的安全性和免疫原性。
一项多中心随机免疫原性试验。婴儿在2、4和6月龄时接种三种PRP-T批次中的一种。对照组接种与CRM197结合的b型流感嗜血杆菌寡聚物（HbOC）。在每次注射前和第三剂后1个月采集血清，并在一个实验室进行抗体盲测。
来自五个地理区域私立儿科诊所的484名婴儿。
接受PRP-T或HbOC的婴儿报告的不良事件数量无显著差异，发生率未超过之前单独接种白喉-破伤风-百日咳疫苗的婴儿。对336名符合严格纳入标准的婴儿的血清总抗PRP抗体反应进行了分析。接种一剂、两剂或三剂后，三种PRP-T批次和HbOC疫苗各自的抗体反应相似。唯一的例外是一个PRP-T批次，在接种一剂或两剂后，其几何平均抗体反应显著高于其他两个批次或HbOC疫苗。第三次注射后，批次间无显著差异。合并不同批次的数据，三剂PRP-T或HbOC后的几何平均抗体浓度无显著差异（8.3 vs 7.7微克/毫升），分别有95%和91%的婴儿抗体浓度大于1.0微克/毫升。接受PRP-T或HbOC的婴儿之间，各自的IgG1、IgG2和IgM特异性抗体浓度大小无显著差异。
所测试的三种研究用PRP-T批次是安全的，其免疫原性与已获许可的HbOC结合疫苗相当或更强。
