Huang L M, Lee C Y, Lin T Y, Chen J M, Lee P I, Hsu C Y
Department of Pediatrics, National Taiwan University Hospital, Taipei, Republic of China.
Vaccine. 1996 Jun;14(9):916-22. doi: 10.1016/0264-410x(95)00257-2.
A second generation acellular pertussis vaccine (component pertussis vaccine) containing purified pertussis toxin (PT) and filamentous hemagglutinin (FHA) was tested for its immunogenicity and safety in 2-month-old infants in comparison with first-generation acellular and whole-cell pertussis vaccines. At the ages of 2, 4, 6, and 18 months, respectively, 350 subjects were inoculated one dose of pertussis vaccine, which was combined with diphtheria and tetanus toxoids. Both acellular and component vaccines elicited significantly much fewer local and systemic reactions than whole-cell vaccine did. Besides, although not reaching statistical significance, the component vaccine was less reactogenic than the acellular vaccine. After each dose of the primary immunization, antibodies against PT and FHA were much higher in acellular and component pertussis vaccinees than in whole-cell vaccinees. However, at 18 months of age, just before the booster dose, both anti-PT and anti-FHA declined very close to, or even lower than, the prevaccination levels in all three groups and then responded rapidly to a booster dose to attain high levels. The booster responses were also significantly higher (P < 0.01) in acellular and component groups than in whole-cell group. Component and acellular vaccines induced similar levels of anti-FHA but the former induced higher anti-PT than the latter (P < 0.01). Our results indicate that both in primary immunization and as a booster, acellular and component pertussis vaccines are much more immunogenic for PT and FHA and much less reactogenic than whole-cell vaccine. However, the persistence of anti-PT and anti-FHA was not as good as one can expect from other protein antigens without giving a booster dose. A long-term follow-up of the vaccinees has been underway to understand the persistence of these antibodies after the first booster.
一种含有纯化百日咳毒素（PT）和丝状血凝素（FHA）的第二代无细胞百日咳疫苗（组分百日咳疫苗），与第一代无细胞和全细胞百日咳疫苗相比，在2月龄婴儿中进行了免疫原性和安全性测试。分别在2、4、6和18月龄时给350名受试者接种一剂与白喉和破伤风类毒素联合的百日咳疫苗。无细胞疫苗和组分疫苗引起的局部和全身反应均明显少于全细胞疫苗。此外，尽管未达到统计学显著性，但组分疫苗的反应原性低于无细胞疫苗。在每次初免剂量后，无细胞和组分百日咳疫苗接种者体内针对PT和FHA的抗体水平远高于全细胞疫苗接种者。然而，在18月龄即将进行加强免疫前，所有三组中抗PT和抗FHA均下降至非常接近甚至低于接种前水平，随后对加强剂量迅速产生反应并达到高水平。无细胞组和组分组的加强免疫反应也显著高于全细胞组（P<0.01）。组分疫苗和无细胞疫苗诱导的抗FHA水平相似，但前者诱导的抗PT水平高于后者（P<0.01）。我们的结果表明，无论是在初次免疫还是作为加强免疫，无细胞和组分百日咳疫苗对PT和FHA的免疫原性都更强，且反应原性远低于全细胞疫苗。然而，抗PT和抗FHA的持久性不如其他无需加强免疫的蛋白质抗原所预期的那样好。目前正在对疫苗接种者进行长期随访，以了解首次加强免疫后这些抗体的持久性。
