Santos José Ignacio, Martin Amando, De Leon Tirza, Rivera Luis, Gaitán Maria Elisa García, Del Rio Carlos, Oselka Gabriel, Cervantes Yolanda, Rubio Pilar, Clemens Sue Ann Costa, de Mendonça João Silva
Departamento de Medicina Experimental, Facultad de Medicina UNAM and Conrejo Nacional de Vacunación, Ministry of Health, Mexico.
Vaccine. 2002 Mar 15;20(13-14):1887-93. doi: 10.1016/s0264-410x(01)00512-6.
This multicentre study was designed to establish the reactogenicity and immunogenicity profiles of primary and booster vaccination with diphtheria, tetanus, and pertussis whole-cell-hepatitis B/Haemophilus influenzae type-b (DTPw-HB/Hib) administered as either a syringe mix or as separate injections in 400 Latin American children. Both vaccine regimens were equally well tolerated and elicited post-primary excellent seropositivity rates at or close to 100% for all five component antigens. With regard to HB, 100% of subjects in the combined vaccination group, and 98.8% subjects in the separate injection vaccination group reached seroprotective antibody concentrations (>or=10 mIU/ml) 1 month after the primary vaccination course. Equally high anti-PRP antibody concentrations were reached 1 month after vaccination, with 100% of seroprotected subjects in the combined vaccination group (antibody concentrations >or=0.15 microg/ml), against 99.4% in the separate injection vaccination group. Seroprotective anti-HBs and anti-PRP antibody concentration levels persisted approximately 1 year after the primary vaccination course, just prior to booster vaccination. Finally, a significant increase of all antibody concentrations could be observed after the booster vaccination, since all but one subject in the separate injection vaccination group had protective levels of anti-HBs and anti-PRP antibodies 1 month after the booster dose. These results suggest that the combination of DTPw-HB and Hib vaccines provides an effective means for increasing vaccine coverage in childhood vaccination programmes.
这项多中心研究旨在确定400名拉丁美洲儿童接种白喉、破伤风、百日咳全细胞-乙肝/ b型流感嗜血杆菌（DTPw-HB/Hib）疫苗进行初次和加强免疫接种时的反应原性和免疫原性特征，疫苗接种方式为注射器混合接种或分开注射。两种疫苗接种方案的耐受性同样良好，所有五种组分抗原初次接种后的血清阳性率均达到或接近100%，效果极佳。对于乙肝，联合疫苗接种组100%的受试者以及分开注射疫苗接种组98.8%的受试者在初次疫苗接种疗程后1个月达到血清保护性抗体浓度（≥10 mIU/ml）。接种疫苗1个月后，抗PRP抗体浓度同样很高，联合疫苗接种组100%的血清保护受试者（抗体浓度≥0.15 μg/ml），而分开注射疫苗接种组为99.4%。初次疫苗接种疗程后约1年，即在加强免疫接种前，血清保护性抗-HBs和抗-PRP抗体浓度水平持续存在。最后，加强免疫接种后可观察到所有抗体浓度均显著增加，因为分开注射疫苗接种组除一名受试者外，其余所有受试者在加强剂量接种后1个月均具有抗-HBs和抗-PRP抗体的保护水平。这些结果表明，DTPw-HB和Hib疫苗联合使用为提高儿童疫苗接种计划中的疫苗覆盖率提供了一种有效手段。
