Avendano A, Ferreccio C, Lagos R, Horwitz I, Cayazzo M, Fritzell B, Meschievitz C, Levine M
Departmento de Pediatria, Facultad de Medicina Campus Norte, Universidad de Chile, Santiago.
Pediatr Infect Dis J. 1993 Aug;12(8):638-43. doi: 10.1097/00006454-199308000-00003.
The safety and immunogenicity of a vaccine against Haemophilus influenzae type b consisting of purified polyribosylribitol phosphate conjugated to tetanus toxoid (PRP-T) were evaluated in 277 Chilean infants who were randomly assigned to one of three treatment groups: Group A, PRP-T mixed with diphtheria-tetanus-pertussis (DTP) vaccine in a single syringe and given as a single inoculation in one arm and placebo in the other arm; Group B, PRP-T given in one arm and DTP in the other arm; Group C, DTP given in one arm and placebo in the other. Infants were immunized at 2, 4 and 6 months of age and examined daily for 4 days after each immunization. Serum PRP antibodies; tetanus, diphtheria and pertussis antitoxin; pertussis agglutinins; and antibodies to Bordetella pertussis filamentous hemagglutinin were measured at baseline and 2 months after each dose. PRP-T was well-tolerated. After three doses of PRP-T vaccine 100% of infants attained PRP antibody concentrations > or = 0.15 micrograms/ml and 96 to 99% achieved high anti-PRP concentrations (> or = 1.0 micrograms/ml). The post-third dose anti-PRP geometric mean titer was high (6.94 micrograms/ml) in infants who were given PRP-T combined with DTP, although it was somewhat lower than the geometric mean titer of the group who received PRP-T in a separate arm (9.93 micrograms/ml) (P not significant).(ABSTRACT TRUNCATED AT 250 WORDS)
对由与破伤风类毒素结合的纯化多聚核糖基核糖醇磷酸(PRP-T)组成的b型流感嗜血杆菌疫苗的安全性和免疫原性进行了评估,研究对象为277名智利婴儿,他们被随机分配到三个治疗组之一:A组,PRP-T与白喉-破伤风-百日咳(DTP)疫苗混合在一个注射器中,在一侧手臂进行单次接种,另一侧手臂接种安慰剂;B组,一侧手臂接种PRP-T,另一侧手臂接种DTP;C组,一侧手臂接种DTP,另一侧手臂接种安慰剂。婴儿在2、4和6月龄时进行免疫接种,每次免疫接种后每天检查4天。在基线和每次接种后2个月测量血清PRP抗体、破伤风、白喉和百日咳抗毒素、百日咳凝集素以及针对百日咳博德特氏菌丝状血凝素的抗体。PRP-T耐受性良好。在接种三剂PRP-T疫苗后,100%的婴儿PRP抗体浓度≥0.15微克/毫升,96%至99%的婴儿达到高抗PRP浓度(≥1.0微克/毫升)。在接受PRP-T与DTP联合接种的婴儿中,第三剂接种后的抗PRP几何平均滴度较高(6.94微克/毫升),尽管略低于在另一手臂单独接种PRP-T的组的几何平均滴度(9.93微克/毫升)(P值不显著)。(摘要截短于250字)