Glode M, Joffe L, Reisinger K, Blatter M, Plotkin S, Watson B, Grossman L, Asmar B, Berry M, Starobin S
Department of Pediatrics, University of Colorado Health Sciences Center, Denver.
Pediatr Infect Dis J. 1992 Jul;11(7):530-5. doi: 10.1097/00006454-199207000-00005.
A double-blind, randomized, controlled trial comparing 4 lots of acellular pertussis-diphtheria tetanus toxoids vaccine (APDT) to whole cell DTP vaccine in 397 children was conducted at 7 clinical centers. Children were immunized at 17 to 24 months of age and sera were obtained pre- and postimmunization. Sera were analyzed for antibody to pertussis antigens (pertussis toxin, filamentous hemagglutinin, with a molecular weight of 69,000 (69k) outer membrane protein and agglutinogens) and to diphtheria and tetanus toxoids. Information concerning local reactions and systemic events was collected daily for 10 days postimmunization. The acellular vaccine produced significantly fewer local reactions than whole cell DTP. Parents reported that drowsiness or fretfulness occurred significantly less often in APDT vaccine recipients compared with whole cell DTP recipients. Fever greater than or equal to 38.3 degrees C occurred in 8% of APDT vaccine recipients and in 15% of whole cell DTP vaccine recipients (P = 0.06). The only significant difference in immune response to pertussis antigens between the two vaccines was for filamentous hemagglutinin (P less than 0.01) for which significantly higher antibody concentrations were found in the APDT vaccine group. We conclude that this APDT vaccine is safe and immunogenic when administered as a booster dose to 18-month-old children.
在7个临床中心对397名儿童进行了一项双盲、随机、对照试验，比较4批无细胞百日咳-白喉-破伤风类毒素疫苗（APDT）与全细胞百白破疫苗（DTP）。儿童在17至24个月龄时进行免疫接种，并在免疫接种前后采集血清。分析血清中针对百日咳抗原（百日咳毒素、丝状血凝素、分子量为69000（69k）的外膜蛋白和凝集原）以及白喉和破伤风类毒素的抗体。在免疫接种后10天每天收集有关局部反应和全身反应的信息。无细胞疫苗产生的局部反应明显少于全细胞DTP疫苗。家长报告称，与接种全细胞DTP疫苗的儿童相比，接种APDT疫苗的儿童出现嗜睡或烦躁的情况明显较少。8%的APDT疫苗接种者和15%的全细胞DTP疫苗接种者出现体温高于或等于38.3摄氏度的情况（P = 0.06）。两种疫苗在对百日咳抗原的免疫反应方面唯一的显著差异在于丝状血凝素（P < 0.01），在APDT疫苗组中发现该抗原的抗体浓度明显更高。我们得出结论，当作为加强剂量给18个月大的儿童接种时，这种APDT疫苗是安全且具有免疫原性的。
