Feldman S, Perry C S, Andrew M, Jones L, Moffitt J E, Lamb D, Meschievitz C
Department of Pediatrics, University of Mississippi Medical Center, Jackson 39216.
South Med J. 1993 Mar;86(3):269-75, 284.
At 2 months of age, 145 infants were randomized to receive either a two-component acellular pertussis vaccine [lymphocytosis-promoting factor (LPF)/filamentous hemagglutinin (FHA)] or standard whole-cell pertussis vaccine, each combined with diphtheria-tetanus toxoids, as their primary immunization series. Of the 132 subjects (91%) who completed the study, those receiving the acellular vaccine had significantly fewer adverse reactions: 5% vs 30% (local) and 17% vs 30% (systemic, including fever). During the first 24 hours acetaminophen usage, a general measure of adverse reactions, was lower in the test group. Overall, 35% of the acellular vaccine doses were reaction free vs 12% of the whole-cell doses. No serious reactions occurred in either group. Antibody responses to LPF and to FHA were significantly increased after the second and third immunizations with the test vaccine and were consistently higher than levels achieved with the standard vaccine. Thus the two-component acellular pertussis vaccine was associated with fewer adverse reactions and improved serologic responses to LPF and FHA as compared with the currently recommended whole-cell vaccine.
在2个月大时，145名婴儿被随机分为两组，一组接受两成分无细胞百日咳疫苗[淋巴细胞增多促进因子（LPF）/丝状血凝素（FHA）]，另一组接受标准全细胞百日咳疫苗，每组均与白喉-破伤风类毒素联合，作为其初次免疫系列。在完成研究的132名受试者（91%）中，接受无细胞疫苗的受试者不良反应明显较少：局部反应为5%对30%，全身反应（包括发热）为17%对30%。在最初24小时内，作为不良反应一般指标的对乙酰氨基酚使用量，试验组较低。总体而言，35%的无细胞疫苗剂量无反应，而全细胞疫苗剂量为12%。两组均未发生严重反应。用试验疫苗进行第二次和第三次免疫后，对LPF和FHA的抗体反应显著增加，且始终高于标准疫苗所达到的水平。因此，与目前推荐的全细胞疫苗相比，两成分无细胞百日咳疫苗不良反应较少，对LPF和FHA的血清学反应有所改善。
