Christie C D, Garrison K M, Kiely L, Gupta R K, Heubi J, Marchant C D
Divisions of Infectious Diseases and Epidemiology, Children's Hospital Medical Center, Cincinnati, OH, USA.
Clin Infect Dis. 2001 Oct 1;33(7):997-1003. doi: 10.1086/322618. Epub 2001 Sep 5.
The safety and immunogenicity of acellular pertussis (AP) vaccine in outbreak control was determined in a randomized, double-blind, controlled trial. Participants received AP vaccine (n=102), which contained 25 microg of pertussis toxoid (PT) and 3 microg of filamentous hemagglutinin (FHA), or licensed meningococcal vaccine (MN; n=97). Local reactions (pain or tenderness, redness, swelling, and induration) and systemic reactions (fever, sleepiness or lethargy, and irritability) were similar among AP and MN vaccinees. One month after AP vaccination, the geometric mean level of IgG anti-PT was 33.1 microg/mL, with 2-fold increases in 85% of patients and 4-fold increases in 73% of patients; for IgG anti-FHA, the respective values were 34.7 microg/mL, 92%, and 63%. After 6 months of follow-up, no serological evidence of pertussis was seen among symptomatic or asymptomatic subjects. However, recent evidence of Bordetella pertussis infection before immunization was shown. Thus, AP vaccine was safe and immunogenic in adults.
在一项随机、双盲、对照试验中确定了无细胞百日咳(AP)疫苗在疫情控制中的安全性和免疫原性。参与者接受了AP疫苗(n = 102),其含有25微克百日咳毒素(PT)和3微克丝状血凝素(FHA),或已获许可的脑膜炎球菌疫苗(MN;n = 97)。AP疫苗接种者和MN疫苗接种者的局部反应(疼痛或压痛、发红、肿胀和硬结)和全身反应(发热、嗜睡或昏睡以及易怒)相似。AP疫苗接种后1个月,IgG抗PT的几何平均水平为33.1微克/毫升,85%的患者升高2倍,73%的患者升高4倍;对于IgG抗FHA,相应的值分别为34.7微克/毫升、92%和63%。随访6个月后,有症状或无症状受试者中均未发现百日咳的血清学证据。然而,显示了免疫接种前百日咳博德特氏菌感染的近期证据。因此,AP疫苗在成人中是安全且具有免疫原性的。