Afari E A, Kamiya Y, Nkrumah F K, Dunyo S K, Akpedonu P, Kamiya H, Fukai F
Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana.
Ann Trop Paediatr. 1996 Mar;16(1):39-48. doi: 10.1080/02724936.1996.11747802.
A randomized controlled trial of acellular diphtheria/pertussis/tetanus (ADPT) freeze-dried and liquid vaccines in infants was conducted in a peri-urban community (Ashaiman) in southern Ghana. Immunogenicity of the acellular vaccines, persistence of antibodies and adverse reactions were compared with those achieved with a whole-cell diphtheria-pertussis-tetanus (DPT) vaccine. The incidence of pertussis in the vaccine groups and prevalence of pertussis in children under 5 years of age in the study area were also determined. The acellular vaccines produced significantly fewer local and systemic reactions. Local reactions such as swelling and redness were observed in 2% (8/399) to 2.3% (9/385) of the acellular vaccine recipients as against 31% (122/394) in the whole-cell vaccine group. Fever ( > or = 37.5 degrees C) occurred in 7.27% (29/399) to 9.8% (38/385) in the acellular vaccine groups compared with 36.6% (145/394) in the whole-cell vaccine group. Geometric mean titres (GMTs), measured by ELISA, to pertussis toxin (PT) and filamentous haemagglutinin (FHA) were significantly higher in the acellular vaccine groups than in the whole-cell DPT (WCDPT) group. There were no significant differences in the GMTs of tetanus and diphtheria antitoxins between the two groups after each vaccination. Twelve months after primary vaccination, GMTs to PT in the freeze-dried, liquid ADPT groups and the WCDPT group have fallen from 56.23, 62.63 and 44.97 ELISA U/ml to 6.08, 6.18 and 11.30 ELISA U/ml, respectively. GMTs to FHA in all the vaccine groups also dropped during the same period from 49.94, 41.73 and 20.74 ELISA U/ml to 7.26, 7.72 and 5.91 ELISA U/ml, respectively. In this comparative controlled trial, the ADPT vaccines were more immunogenic, with less local and systemic reactions, than the WCDPT vaccine but there was a considerable drop in antibody titres in all the vaccine groups 12 months after primary vaccination. However, the levels of titres of anti-PT and anti-FHA antibodies in all the three vaccines that confer protection are not known. Further studies are necessary to provide this information in order to assess the need for subsequent booster doses after primary immunization with both ADPT and WCDPT vaccines.
在加纳南部一个城郊社区（阿沙伊曼）对婴儿进行了无细胞白喉/百日咳/破伤风（ADPT）冻干疫苗和液体疫苗的随机对照试验。将无细胞疫苗的免疫原性、抗体持久性及不良反应与全细胞白喉-百日咳-破伤风（DPT）疫苗进行了比较。还测定了疫苗组百日咳发病率及研究地区5岁以下儿童百日咳患病率。无细胞疫苗引起的局部和全身反应明显较少。无细胞疫苗接种者中2%（8/399）至2.3%（9/385）出现了如肿胀和发红等局部反应，而全细胞疫苗组这一比例为31%（122/394）。无细胞疫苗组中7.27%（29/399）至9.8%（38/385）出现发热（≥37.5℃），而全细胞疫苗组为36.6%（145/394）。通过酶联免疫吸附测定（ELISA）测得，无细胞疫苗组针对百日咳毒素（PT）和丝状血凝素（FHA）的几何平均滴度（GMT）显著高于全细胞DPT（WCDPT）组。两组每次接种后破伤风和白喉抗毒素的GMT无显著差异。初次接种12个月后，冻干、液体ADPT组及WCDPT组针对PT的GMT分别从56.23、62.63和44.97 ELISA U/ml降至6.08、6.18和11.30 ELISA U/ml。同期所有疫苗组针对FHA的GMT也分别从49.94、41.73和20.74 ELISA U/ml降至7.26、7.72和5.91 ELISA U/ml。在这项对比对照试验中，ADPT疫苗比WCDPT疫苗免疫原性更强，局部和全身反应更少，但初次接种12个月后所有疫苗组抗体滴度均大幅下降。然而，三种具有保护作用疫苗的抗PT和抗FHA抗体滴度水平尚不清楚。需要进一步研究以提供该信息，从而评估初次接种ADPT和WCDPT疫苗后是否需要后续加强剂量。
