Syngene International Limited, Bangalore, India.
Serum Institute of India Pvt Ltd, Pune, India.
Vaccine. 2018 Mar 14;36(12):1542-1544. doi: 10.1016/j.vaccine.2018.02.024. Epub 2018 Feb 10.
Rotavirus Gastroenteritis (RVGE) is an important global public health problem. Recently a Lyophilized Pentavalent Human Bovine Reassortant Rotavirus vaccine (BRV-PV, Rotasiil) was licensed in India. A Liquid formulation of the same vaccine (LBRV-PV) was tested in a Phase I clinical trial.
Total 20 healthy adults were given a single oral dose of LBRV-PV and were followed for one month for safety outcomes: immediate reactions, solicited reactions, unsolicited adverse events and serious adverse events.
All 20 adults completed the study without any major protocol deviations. No immediate reaction, solicited reactions and unsolicited adverse events were reported during the study. No clinically significant changes were seen in the vital parameters and safety laboratory test results.
LBRV-PV developed in India was safe and well tolerated in adults. Further clinical development of this vaccine in infants should be undertaken. Trial Registration - CTRI/2015/11/006,384.
轮状病毒胃肠炎（RVGE）是一个重要的全球性公共卫生问题。最近，一种冻干五价人-牛重配轮状病毒疫苗（BRV-PV，Rotasiil）在印度获得许可。该疫苗的一种液体制剂（LBRV-PV）已在 I 期临床试验中进行了测试。
总共 20 名健康成年人接受了单次口服 LBRV-PV 剂量，并在一个月内进行随访以评估安全性结果：即刻反应、预期反应、非预期不良事件和严重不良事件。
所有 20 名成年人均完成了研究，没有出现任何主要方案偏离。研究期间未报告任何即刻反应、预期反应和非预期不良事件。重要生命体征和安全性实验室检测结果无临床显著变化。
在印度开发的 LBRV-PV 在成年人中是安全且耐受良好的。应在婴儿中进一步开展该疫苗的临床开发。试验注册：CTRI/2015/11/006,384。
