University of Tampere, Medical School, FIN-33014 Tampere, Finland.
Vaccine. 2010 Jul 19;28(32):5272-9. doi: 10.1016/j.vaccine.2010.05.057. Epub 2010 Jun 9.
This study assessed the immunogenicity and safety of a human rotavirus vaccine RIX4414; the effect of co-administration of childhood vaccines on the immune responses was also assessed. Healthy infants aged 6-14 weeks received two doses of RIX4414/placebo concomitantly with the primary childhood vaccination (Infanrix hexa, Infanrix quinta,Meningitec and/or Prevnar), respecting the vaccination schedule of each country. Anti-rotavirus IgA seroconversion rate (ELISA cut-off 20 U/ml) was measured pre-vaccination and 1-2 months post-Dose 2. Immune response against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, inactivated polio virus, pneumococcal polysaccharide conjugate (France and Germany) and meningococcal group C conjugate vaccines (Spain) were measured approximately 1-month post-Dose 3. An overall anti-rotavirus IgA seroconversion rate of 86.5%(95% CI: 83.9-88.8) was observed in the RIX4414 group 1-month post-Dose 2. The seroconversion rate in Finland and Italy (3 and 5-month schedule) was 94.6%(95% CI: 90.0-97.5) and 92.3%(95% CI: 64.0-99.8), respectively. Immune response to the childhood vaccines was unaffected following co-administration with RIX4414. Reactogenicity profile was similar for RIX4414 and placebo groups. RIX4414 was immunogenic and well tolerated in European infants and the co-administration of routine childhood vaccines with RIX4414 did not negatively impact the immune responses to these vaccines.
本研究评估了人轮状病毒疫苗 RIX4414 的免疫原性和安全性；还评估了同时给予儿童疫苗对免疫应答的影响。6-14 周龄的健康婴儿同时接受 RIX4414/安慰剂和基础儿童疫苗接种（Infanrix hexa、Infanrix quinta、Meningitec 和/或 Prevnar），遵循每个国家的疫苗接种时间表。在接种前和第 2 剂后 1-2 个月，采用 ELISA（cut-off 20 U/ml）检测抗轮状病毒 IgA 血清转化率。接种第 3 剂后约 1 个月，检测白喉、破伤风、百日咳、乙型肝炎、流感嗜血杆菌 b 型、灭活脊髓灰质炎病毒、肺炎球菌多糖结合疫苗（法国和德国）和脑膜炎球菌 C 型结合疫苗（西班牙）的免疫应答。RIX4414 组在第 2 剂后 1 个月观察到 86.5%（95%CI：83.9-88.8）的总体抗轮状病毒 IgA 血清转化率。在芬兰和意大利（3 个月和 5 个月的时间表），血清转化率分别为 94.6%（95%CI：90.0-97.5）和 92.3%（95%CI：64.0-99.8）。RIX4414 与儿童疫苗联合使用后，对这些疫苗的免疫应答没有影响。RIX4414 和安慰剂组的不良反应谱相似。RIX4414 在欧洲婴儿中具有免疫原性且耐受性良好，同时给予常规儿童疫苗与 RIX4414 联合使用不会对这些疫苗的免疫应答产生负面影响。
