Siber G R, Thakrar N, Yancey B A, Herzog L, Todd C, Cohen N, Sekura R D, Lowe C U
Laboratory of Infectious Diseases, Dana-Farber Cancer Institute, Boston, MA.
Vaccine. 1991 Oct;9(10):735-40. doi: 10.1016/0264-410x(91)90289-i.
The immunogenicity and adverse effects of an acellular pertussis vaccine consisting of a purified pertussis toxin inactivated with hydrogen peroxide (PTxd) was evaluated. Children aged 15 to 30 months were injected with 10 (n = 33) or 50 micrograms (n = 34) of PTxd or with diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP) (n = 34). All children had previously received three doses of DTP during infancy. Both dosages of PTxd induced higher IgG antibody (p less than 0.05 for 10 micrograms dose and p less than 0.01 for 50 micrograms dose) and pertussis antitoxin responses (p less than 0.01 for 50 micrograms dose) than DTP. The 50 micrograms dose gave slightly higher (though not significantly) antibody responses than the 10 micrograms dose of PTxd. None of the vaccines induced detectable IgM or IgA antibody responses to pertussis toxin. At 24 h, local reactions occurred in none of the children injected with 10 micrograms PTxd, 12% with 50 micrograms PTxd and 78% with DTP. Fever at 24 h occurred in 13% after 10 micrograms PTxd, in none after 50 micrograms PTxd and in 53% after DTP. Recipients of DTP, but not of PTxd, had significant increases in neutrophils and decreases in lymphocytes and haematocrit at 24 h (all p less than 0.05). None of the groups showed changes in blood glucose at 24 h. PTxd induced pertussis toxin antibody levels similar to those observed in patients convalescing from natural pertussis. This acellular pertussis vaccine deserves further evaluation for safety and immunogenicity in infants and for efficacy in preventing pertussis.
对一种由用过氧化氢灭活的纯化百日咳毒素（PTxd）组成的无细胞百日咳疫苗的免疫原性和不良反应进行了评估。对15至30个月大的儿童注射10微克（n = 33）或50微克（n = 34）的PTxd，或注射白喉和破伤风类毒素及全细胞百日咳疫苗（DTP）（n = 34）。所有儿童在婴儿期均已接种过三剂DTP。PTxd的两种剂量诱导的IgG抗体（10微克剂量时p < 0.05，50微克剂量时p < 0.01）和百日咳抗毒素反应（50微克剂量时p < 0.01）均高于DTP。50微克剂量的PTxd产生的抗体反应略高于10微克剂量的PTxd（尽管无统计学意义）。没有一种疫苗诱导出可检测到的针对百日咳毒素的IgM或IgA抗体反应。在24小时时，注射10微克PTxd的儿童均未出现局部反应，注射50微克PTxd的儿童中有12%出现局部反应，注射DTP的儿童中有78%出现局部反应。注射10微克PTxd后，24小时时13%的儿童出现发热，注射50微克PTxd后无儿童发热，注射DTP后53%的儿童发热。注射DTP的儿童在24小时时中性粒细胞显著增加，淋巴细胞和血细胞比容降低（所有p < 0.05），而注射PTxd的儿童则无此现象。所有组在24小时时血糖均无变化。PTxd诱导的百日咳毒素抗体水平与自然感染百日咳康复患者中观察到的水平相似。这种无细胞百日咳疫苗在婴儿的安全性和免疫原性以及预防百日咳的有效性方面值得进一步评估。
