PATH, India.
Serum Institute of India Pvt. Ltd., Pune, India.
Vaccine. 2018 Dec 18;36(52):7943-7949. doi: 10.1016/j.vaccine.2018.11.006. Epub 2018 Nov 9.
A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency.
This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards.
The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B: 1.07; Lot A versus Lot C: 1.06; and Lot B versus Lot C: 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were: BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.
Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].
一种耐热牛-人轮状病毒重组五价疫苗（BRV-PV，ROTASIIL®）在印度开发。在这项研究中，对该疫苗的安全性、免疫原性和临床批间一致性进行了测试。
这是一项 III 期、开放性标签、随机、等效性设计研究。主要目的是证明 BRV-PV 的批间一致性。受试者随机分为四组，三组分别接受 BRV-PV 的 A、B 和 C 批，对照组接受 Rotarix®。在 6、10 和 14 周龄时，三组分别接受 3 剂 BRV-PV 或 2 剂 Rotarix®和 1 剂安慰剂。在第三剂后四周采集血样，以评估轮状病毒 IgA 抗体水平。如果 BRV-PV 的三个批次的几何平均浓度（GMC）比值的 95%置信区间（CI）在 0.5 到 2 之间，则认为三个批次是等效的。使用日记卡收集了应征反应。
该研究在 1500 名随机婴儿中进行，其中 1341 名婴儿完成了研究。三个批次的 IgA GMC 比值约为 1（Lot A 与 Lot B：1.07；Lot A 与 Lot C：1.06；Lot B 与 Lot C：0.99）。GMC 比值的 95%CI 在 0.78 到 1.36 之间。IgA GMC 分别为：BRV-PV 组 19.16（95%CI 17.37-21.14）和 Rotarix®组 10.92（95%CI 9.36-12.74）（GMC 比值 1.75；90%CI 1.51-2.04）。血清阳性率分别为 46.98%（95%CI 43.86-50.11）和 31.12%（95%CI 26.17-36.41）。四个组的应征反应发生率相似。除 BRV-PV 组的两例胃肠炎事件外，与研究疫苗相关的不良事件均不严重。
从 IgA 抗体的 GMC 比值来看，BRV-PV 的批间一致性得到了证明。疫苗的安全性和免疫原性与 Rotarix®相似。临床试验.gov [NCT02584816]和印度临床试验注册处 [CTRI/2015/07/006034]。
