人轮状病毒疫苗（RIX4414）在印度婴儿中的免疫原性、反应原性及安全性
Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants.
作者信息
Narang Anil, Bose Anuradha, Pandit Anand Nilkanth, Dutta Phalguni, Kang Gagandeep, Bhattacharya Sujit Kumar, Datta Sanjoy Kumar, Suryakiran P V, Delem Andrée, Han Htay Htay, Bock Hans Ludwig
机构信息
Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
出版信息
Hum Vaccin. 2009 Jun;5(6):414-9. doi: 10.4161/hv.5.6.8176. Epub 2009 Jun 15.
AIM
This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting.
RESULTS
The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups.
PATIENTS AND METHODS
Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study.
CONCLUSIONS
Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants.
CLINICAL TRIALS REGISTRATION
ClinicalTrials.gov; NCT00289172; eTrack 103792.
目的
本研究旨在评估两剂口服减毒活人类轮状病毒疫苗RIX4414（Rotarix()）在印度环境中的免疫原性、反应原性和安全性。
结果
RIX4414组在第2剂接种后1个月观察到的血清转化率为58.3%[95%置信区间：48.7；67.4]，与安慰剂组的6.3%[95%置信区间：2.5；12.5]相比显著更高。两组的反应原性和安全性概况相似。
患者和方法
纳入年龄约8周的健康婴儿（N = 363），接受两剂RIX4414疫苗（n = 182）或安慰剂（n = 181），间隔1个月。为评估免疫反应，在接种疫苗前以及接种RIX4414/安慰剂第2剂后1个月采集血样。在每次接种后8天收集主动报告的症状，并在整个研究过程中收集安全性数据。
结论
两剂RIX4414（Rotarix()）具有免疫原性，安全性良好，在健康的印度婴儿中给药时耐受性良好。
临床试验注册
ClinicalTrials.gov；NCT00289172；电子追踪号103792。
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