Parke J C, Schneerson R, Reimer C, Black C, Welfare S, Bryla D, Levi L, Pavliakova D, Cramton T, Schulz D
Department of Pediatrics, Carolinas Medical Center, Charlotte, NC 28232-2861.
J Pediatr. 1991 Feb;118(2):184-90. doi: 10.1016/s0022-3476(05)80480-9.
The safety and immunogenicity of Haemophilus influenzae type b-tetanus toxoid conjugate vaccine (Hib-TT) were evaluated in 77 healthy infants receiving injections at 3, 5, 7, and 18 months of age. No serious local or systemic reactions were noted. After the first injection the geometric mean Hib antibody level rose to 0.55 micrograms/ml, and each subsequent injection elicited a statistically significant rise in the geometric mean. The percentage of vaccinees with Hib antibody levels greater than 0.15 micrograms/ml serum was 75.5% after the first, 97.4% after the second, and 100% after the third Hib-TT injection. This percentage fell to 90.9% at 18 months of age but rose again to 100% after the fourth injection. Control infants (n = 10) injected with diphtheria-tetanus toxoid-pertussis vaccine only had nondetectable levels after the second injection. Hib-TT elicited increases of Hib antibody in all isotypes: IgG greater than IgM greater than IgA. Among IgG subclasses the highest increases were of IgG1. All vaccinated subjects had greater than 0.01 U/ml of TT antibody (estimated protective level) throughout the study. We conclude that Hib-TT, injected at 3, 5, 7, and 18 months, is safe and induces protective levels of antibodies during the age of highest incidence of meningitis caused by Hib.
对77名在3、5、7和18月龄时接受注射的健康婴儿评估了b型流感嗜血杆菌-破伤风类毒素结合疫苗（Hib-TT）的安全性和免疫原性。未观察到严重的局部或全身反应。首次注射后，Hib抗体几何平均水平升至0.55微克/毫升，随后每次注射均引起几何平均值有统计学意义的升高。首次Hib-TT注射后，血清Hib抗体水平大于0.15微克/毫升的接种者百分比为75.5%，第二次注射后为97.4%，第三次注射后为100%。该百分比在18月龄时降至90.9%，但在第四次注射后再次升至100%。仅接种白喉-破伤风类毒素-百日咳疫苗的对照婴儿（n = 10）在第二次注射后检测不到抗体水平。Hib-TT在所有同种型中均引起Hib抗体增加：IgG＞IgM＞IgA。在IgG亚类中，IgG1增加最多。在整个研究过程中，所有接种疫苗的受试者的破伤风抗体水平均大于0.01 U/ml（估计的保护水平）。我们得出结论，在3、5、7和18月龄时注射Hib-TT是安全的，并且在由b型流感嗜血杆菌引起的脑膜炎发病率最高的年龄段可诱导产生保护性抗体水平。
