Miller E, Waight P, Laurichesse H, Andrews N, Thornton C, Sesardic D, Corbel M
Immunisation Division, PHLS Communicable Disease Surveillance Centre, 61 Colindale Avenue, London NW9 5EQ, UK.
Vaccine. 2001 Jul 16;19(28-29):3904-11. doi: 10.1016/s0264-410x(01)00123-2.
Four acellular diphtheria/tetanus/pertussis (aDTP) vaccines were compared with two diphtheria/tetanus (DT) vaccines given as a pre-school booster to 1033 children aged 4 to < 6 years who had completed primary immunisation with DTP vaccine according to the UK 2, 3 and 4 month schedule; 71 children had received aDTP vaccine and the remaining 962 a whole cell DTP vaccine for primary immunisation. The effect of simultaneous administration of a second dose of MMR vaccine was evaluated in 374 (37%). Overall, there was little difference in the frequency of post-vaccination symptoms in DT and aDTP vaccinees, although local reactions occurred more quickly in the aDTP group. The concomitant administration of MMR had no effect on local reactions or fever within 10 days, or on the proportions requiring a doctor's visit in the 4--6 week post-vaccination period. Local reactions > or = 3 cm were higher on day 2 in children who had received aDTP for primary immunisation (erythema 32.4% vs. 17.4% for wDTP, P = 0.0012; swelling 28.2% vs. 15.5%, P = 0.0027). Pertussis antibody responses were consistent with the antigen content of the aDTP vaccines. All were more immunogenic with respect to PT -- the only pertussis antigen which by itself has been shown to be protective in clinical trials -- than a wDTP pre-school booster given in an earlier trial. MMR vaccine had no significant effect on antibody responses to either the pertussis or diphtheria and tetanus antigens. Diphtheria antibody responses in children who had received wDTP for primary immunisation were 2.8 times higher than in those who had received aDTP vaccine (P < 0.0001); they were also higher in children who had received a single dose of a Haemophilus influenzae type b vaccine containing CRM(197) conjugate after 12 months of age. For countries currently using DT vaccines as a pre-school booster, replacement with an aDTP vaccine is unlikely to have a perceptible effect on reactogenicity, at least in children given wDTP for primary immunisation, and would boost antibody levels to antigens known to be associated with protection.
将四种无细胞白喉/破伤风/百日咳（aDTP）疫苗与两种白喉/破伤风（DT）疫苗进行了比较，这些疫苗作为学龄前加强疫苗接种给1033名4至<6岁已按照英国2、3和4月龄接种程序完成DTP疫苗基础免疫的儿童；71名儿童接受了aDTP疫苗，其余962名儿童接受了全细胞DTP疫苗进行基础免疫。在374名（37%）儿童中评估了同时接种第二剂MMR疫苗的效果。总体而言，DT疫苗接种者和aDTP疫苗接种者接种后症状的发生率差异不大，尽管aDTP组的局部反应出现得更快。同时接种MMR对10天内的局部反应或发热以及接种后4 - 6周内需要就医的比例没有影响。接受aDTP进行基础免疫的儿童在第2天局部反应≥3 cm的比例更高（红斑：aDTP组为32.4%，全细胞DTP组为17.4%，P = 0.0012；肿胀：aDTP组为28.2%，全细胞DTP组为15.5%，P = 0.0027）。百日咳抗体反应与aDTP疫苗的抗原含量一致。相对于PT（唯一在临床试验中已证明自身具有保护作用的百日咳抗原）而言，所有aDTP疫苗的免疫原性均高于早期试验中使用的全细胞DTP学龄前加强疫苗。MMR疫苗对百日咳或白喉和破伤风抗原的抗体反应没有显著影响。接受全细胞DTP进行基础免疫的儿童的白喉抗体反应比接受aDTP疫苗的儿童高2.8倍（P < 0.0001）；在12月龄后接种过一剂含CRM(197)结合物的b型流感嗜血杆菌疫苗的儿童中，白喉抗体反应也更高。对于目前使用DT疫苗作为学龄前加强疫苗的国家，至少在接受全细胞DTP进行基础免疫的儿童中，用aDTP疫苗替代不太可能对反应原性产生明显影响，并且会提高与保护相关抗原的抗体水平。
