Badgett J T, Rodgers G C
South Med J. 1987 Sep;80(9):1075-8. doi: 10.1097/00007611-198708090-00002.
In an open-label study, we evaluated the safety and immunogenicity of a diphtheria-tetanus-pertussis (DTP) vaccine containing an acellular pertussis component. Thirty-one normal, healthy children 4 to 6 years old received a single dose. All subjects had received their primary DTP series and DTP booster at age 18 months. All but three of the subjects were followed up for one month. Two subjects developed fever (100 F [37.8 C]) during the 24 hours after dosing. Eleven subjects had mild local reactions reported by parents at the 24-hour visit. One subject had a small "sterile abscess." Paired antibody assays revealed enhancement of titers in 19 of 21 for pertussis, 20 of 21 for diphtheria, and 19 of 21 for tetanus. Although the sample is small, the experimental vaccine appears to have been safe and effective in the subjects studied.
在一项开放标签研究中，我们评估了一种含有无细胞百日咳成分的白喉-破伤风-百日咳（DTP）疫苗的安全性和免疫原性。31名4至6岁的正常健康儿童接受了单剂量疫苗接种。所有受试者在18个月大时均已完成其主要的DTP系列接种和DTP加强接种。除3名受试者外，其余所有受试者均接受了为期1个月的随访。两名受试者在接种后24小时内出现发热（100°F [37.8°C]）。11名受试者的父母在24小时随访时报告有轻度局部反应。一名受试者出现了一个小的“无菌脓肿”。配对抗体检测显示，21名受试者中有19名百日咳抗体滴度升高，21名中有20名白喉抗体滴度升高，21名中有19名破伤风抗体滴度升高。尽管样本量较小，但在研究的受试者中，该实验性疫苗似乎是安全有效的。
