Black Steven, Friedland Leonard R, Schuind Anne, Howe Barbara
Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, USA.
Vaccine. 2006 Aug 28;24(35-36):6163-71. doi: 10.1016/j.vaccine.2006.04.001. Epub 2006 Apr 21.
Combination vaccines represent one solution to the problem of increased numbers of injections during single clinic visits. A combined DTaP-IPV (Infanrix-IPV) vaccine has been developed for use as a pre-school booster. Four hundred healthy children aged 4-6 years previously primed with 4 doses of DTaP vaccine (Infanrix), 3 doses of poliovirus vaccine and 1 dose of MMR vaccine were randomized to receive single doses of either the combined DTaP-IPV vaccine or separate DTaP and IPV vaccines in a Phase II trial (DTaP-IPV-047). All children also received a second dose of MMR vaccine. Immunogenicity was assessed in serum samples taken before and 1 month after booster administration. Safety was actively assessed for 42 days post-vaccination. Non-inferiority of the DTaP-IPV vaccine to separate DTaP and IPV vaccines was demonstrated for all DTaP antigen booster response rates and poliovirus geometric mean titers of antibody ratios. Post-vaccination, > or =99.4% of children in both groups had seroprotective levels of anti-diphtheria and anti-tetanus antibodies (> or =0.1IU/mL) and seroprotective anti-poliovirus antibody titers (> or =1:8). All children in both groups were seropositive for measles, mumps and rubella antibodies, with similar post-vaccination geometric mean concentrations/titers. No significant differences were observed in the incidence of solicited local or general symptoms, unsolicited symptoms and serious adverse events between the two groups. This combined DTaP-IPV appeared safe and immunogenic when given as a booster dose at 4-6 years of age. The DTaP-IPV vaccine had no negative effect on the response to co-administered MMR vaccine, making it well-suited for use as a pre-school booster.
联合疫苗是解决单次门诊就诊时注射次数增加这一问题的一种方法。一种联合的白百破-灭活脊髓灰质炎疫苗（Infanrix-IPV）已被开发用作学龄前加强疫苗。在一项II期试验（DTaP-IPV-047）中，400名4至6岁的健康儿童，此前已接种4剂白百破疫苗（Infanrix）、3剂脊髓灰质炎病毒疫苗和1剂麻腮风疫苗，被随机分配接受单剂联合白百破-灭活脊髓灰质炎疫苗或单独的白百破疫苗和灭活脊髓灰质炎疫苗。所有儿童还接受了第二剂麻腮风疫苗。在加强免疫前和加强免疫后1个月采集的血清样本中评估免疫原性。在接种疫苗后42天积极评估安全性。对于所有白百破抗原加强免疫反应率和脊髓灰质炎病毒抗体比率的几何平均滴度，白百破-灭活脊髓灰质炎疫苗不劣于单独的白百破疫苗和灭活脊髓灰质炎疫苗。接种疫苗后，两组中≥99.4%的儿童具有抗白喉和抗破伤风抗体的血清保护水平（≥0.1IU/mL）以及抗脊髓灰质炎病毒抗体滴度的血清保护水平（≥1:8）。两组中的所有儿童麻疹、腮腺炎和风疹抗体均为血清阳性，接种疫苗后的几何平均浓度/滴度相似。两组在诱发的局部或全身症状、非诱发症状和严重不良事件的发生率方面未观察到显著差异。这种联合的白百破-灭活脊髓灰质炎疫苗在4至6岁作为加强剂量接种时似乎是安全且具有免疫原性的。白百破-灭活脊髓灰质炎疫苗对同时接种的麻腮风疫苗的反应没有负面影响，使其非常适合用作学龄前加强疫苗。
