Drucker J, Soula G, Diallo O, Fabre P
Dev Biol Stand. 1986;65:145-51.
A new combined DPT-Poliovirus vaccine (DPTP) has been developed in France. It contains the DPT components mixed with poliovirus antigens, prepared by culture on vero cells on microcarriers, inactivated by formalin and formulated at a level of 40-8-32 D-antigen units for the type 1, 2 and 3 respectively. A clinical evaluation of this vaccine was conducted in Mali (West Africa) among 320 infants 3 to 24 months of age. The infants were randomly assigned to 3 groups. One group received 2 doses of DPTP, a second group 2 doses of DPT and poliovirus vaccine (IPV) given in two separate sites, the third group 2 doses of DPT and oral poliovirus vaccine (OPV). In each group the 2 doses were given 3 months a part. No severe adverse reactions were observed and no statistical difference was noticed between the three groups for minor side effects. A seroconversion rate of 100% was observed to poliovirus antigens in the groups who received IPV simultaneously or combined with DPT, as compared to 49 to 77% in the group who received OPV. A seroconversion rate of 100%, 100% and 92% was shown in the DPTP group respectively to diphtheria, tetanus and pertussis antigens. No statistical difference was recorded between the 3 groups in the serological response to DPT antigens. A follow-up could be performed in 74 children one year after primary vaccination and a dramatic response to a booster dose of DPTP was measured.(ABSTRACT TRUNCATED AT 250 WORDS)
法国研发出一种新的白喉-百日咳-破伤风-脊髓灰质炎联合疫苗(DPTP)。它含有与脊髓灰质炎病毒抗原混合的白喉-百日咳-破伤风成分,通过在微载体上的vero细胞培养制备,经福尔马林灭活,1型、2型和3型分别按40-8-32 D抗原单位配制。在马里(西非)对320名3至24个月大的婴儿进行了该疫苗的临床评估。婴儿被随机分为3组。一组接种2剂DPTP,第二组在两个不同部位分别接种2剂白喉-百日咳-破伤风疫苗和脊髓灰质炎疫苗(IPV),第三组接种2剂白喉-百日咳-破伤风疫苗和口服脊髓灰质炎疫苗(OPV)。每组的两剂疫苗间隔3个月接种。未观察到严重不良反应,三组在轻微副作用方面未发现统计学差异。与接种OPV的组中49%至77%的血清转化率相比,同时接种IPV或与白喉-百日咳-破伤风疫苗联合接种的组中,脊髓灰质炎病毒抗原的血清转化率为100%。DPTP组对白喉、破伤风和百日咳抗原的血清转化率分别为100%、100%和92%。三组对白喉-百日咳-破伤风抗原的血清学反应未记录到统计学差异。初次接种疫苗一年后,对74名儿童进行了随访,测量到对一剂DPTP加强针有显著反应。(摘要截短至250字)