Trollfors B, Taranger J, Lagergård T, Lind L, Sundh V, Zackrisson G, Lowe C U, Blackwelder W, Robbins J B
Department of Pediatrics, Göteborg University, Sweden.
N Engl J Med. 1995 Oct 19;333(16):1045-50. doi: 10.1056/NEJM199510193331604.
Although many whole-cell vaccines have been effective in preventing pertussis, these vaccines are difficult to standardize and can produce side effects. In Sweden, pertussis became endemic during the 1970s despite vaccination. Because of its limited efficacy, the Swedish-made whole-cell vaccine was withdrawn in 1979.
To evaluate the efficacy of an acellular vaccine consisting of pertussis toxin inactivated by hydrogen peroxide (pertussis toxoid), we conducted a randomized, double-blind, placebo-controlled trial in Sweden. Infants were vaccinated with either diphtheria and tetanus toxoids alone (DT toxoids, 1726 infants) or diphtheria, tetanus, and pertussis toxoids (DTP toxoids, 1724 infants) at 3, 5, and 12 months of age.
There were no serious reactions. With the pertussis vaccine there were slightly more local reactions than with the DT toxoids alone, but the rates of postvaccination fever were the same. The main period of surveillance, which began 30 days after the third vaccination, continued for a median of 17.5 months. There were 312 cases of pertussis (72 in the DTP-toxoids group and 240 in the DT-toxoids group) that met the clinical criterion (paroxysmal cough lasting > or = 21 days) and laboratory criteria for pertussis as defined by the World Health Organization. The efficacy of this acellular vaccine was 71 percent (95 percent confidence interval, 63 to 78 percent). The recipients of DTP toxoids who had pertussis had cough of shorter duration than the recipients of DT toxoids, and fewer had whooping and vomiting. The vaccine efficacy after two doses was 55 percent (95 percent confidence interval, 12 to 78 percent), on the basis of 14 cases in the DTP-toxoids group and 31 in the DT-toxoids group that met the definition of the World Health Organization.
A pharmacologically inert, acellular pertussis-toxoid vaccine that is easily standardized is safe and confers substantial protection against pertussis.
尽管许多全细胞疫苗在预防百日咳方面有效，但这些疫苗难以标准化且可能产生副作用。在瑞典，尽管进行了疫苗接种，百日咳在20世纪70年代仍成为地方病。由于其疗效有限，瑞典生产的全细胞疫苗于1979年被停用。
为评估一种由过氧化氢灭活的百日咳毒素（百日咳类毒素）组成的无细胞疫苗的疗效，我们在瑞典进行了一项随机、双盲、安慰剂对照试验。婴儿在3、5和12月龄时分别接种白喉和破伤风类毒素（DT类毒素，1726名婴儿）或白喉、破伤风和百日咳类毒素（DTP类毒素，1724名婴儿）。
未出现严重反应。与单独使用DT类毒素相比，接种百日咳疫苗后局部反应略多，但接种后发热率相同。主要监测期在第三次接种后30天开始，持续时间中位数为17.5个月。有312例百日咳病例（DTP类毒素组72例，DT类毒素组240例）符合临床标准（阵发性咳嗽持续≥21天）以及世界卫生组织定义的百日咳实验室标准。这种无细胞疫苗的疗效为71%（95%置信区间，63%至78%）。患百日咳的DTP类毒素接种者咳嗽持续时间比DT类毒素接种者短，且出现哮吼和呕吐的较少。根据DTP类毒素组14例和DT类毒素组31例符合世界卫生组织定义的病例，两剂疫苗后的疫苗效力为55%（95%置信区间，12%至78%）。
一种药理学上无活性、易于标准化的无细胞百日咳类毒素疫苗是安全的，并且能提供对百日咳的实质性保护。
