Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants
Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants
复制标题
DOI：
10.1016/j.vaccine.2014.03.069
复制
发表时间：
2014-08-11
期刊：
影响因子：
5.5
通讯作者：
Saluja, T.
中科院分区：
文献类型：
--
作者：
Dhingra, M. S.;Kundu, R.;Saluja, T.
背景：轮状病毒感染，在世界范围内流行的人群中，大多数是由A组病毒引起的。轮状病毒减毒活疫苗在预防严重轮状病毒胃肠炎方面非常有效。然而，这些疫苗的成本和当地可用性可能是发展中国家公共卫生计划广泛采用的障碍，在发展中国家，婴儿遭受轮状病毒相关发病率和死亡率的沉重负担。进行了I/II期研究的长期目标，以生产一种当地许可的疫苗，这是同样安全和免疫原性相比，现有的许可疫苗。在第一个队列中，20名健康成年人接受了单剂量的轮状病毒疫苗（计划用于婴儿的最高抗原浓度）或安慰剂，并进行了10天的安全性随访。在成年志愿者中证明安全性后，招募了100名健康婴儿（队列2），并随机分为5个相等的研究组。在6-8、10-12和14-16周龄时，给予三剂试验用轮状病毒疫苗（BRV-TV）（三种抗原浓度之一）或Rotateq或安慰剂。对所有婴儿进行安全性随访，直至第三次给药后28天。免疫反应的疫苗，在血清应答和几何平均浓度，进行了比较，在五个研究groups.Results：增加抗轮状病毒血清伊加抗体从基线，表现出较高的免疫应答的所有三个抗原浓度的BRV-TV疫苗和RotaTeq与安慰剂相比。使用4倍或以上标准，安慰剂、BRV-TV剂量水平10（5.0）FFU、10（5.8）FFU、10（6.4）FFU和Rotateq在第3次给药后28天的血清应答率分别为11.1%、27.8%、41.2%、83.3%和63.2%。在每次疫苗给药后28天，与活性对照组（RotaTeq）相比，对应于最高抗原浓度10（6 4）FFU的BRV-TV疫苗组的血清应答率更高。结论：总体而言，结果表明，所有三个剂量的BRV-TV疫苗是安全的，耐受性良好，并显示良好的免疫原性（剂量反应）在健康的印度婴儿。(C)2014由Elsevier Ltd.出版
Background: Rotavirus infections, prevalent in human populations worldwide are mostly caused by Group A viruses. Live attenuated rotavirus vaccines are highly effective in preventing severe rotavirus gastroenteritis. However, the cost of these vaccines and local availability can be a barrier for widespread adoption in public health programs in developing countries where infants suffer a heavy burden of rotavirus related morbidity and mortality. A phase I/II study was carried out with the long term aim to produce a locally licensed vaccine which is equally safe and immunogenic as compared to available licensed vaccines.Methods: This study was conducted in two cohorts. In the first cohort, 20 healthy adults were administered a single dose of the rotavirus vaccine (highest antigen concentration planned for infants) or placebo and were followed up for 10 days for safety. Following demonstration of safety in adult volunteers, 100 healthy infants were recruited (cohort 2) and randomly divided into five equal study groups. They were administered three doses of either the investigational rotavirus vaccine (BRV-TV) at one of the three antigen concentrations or Rotateq or Placebo at 6-8, 10-12 and 14-16 weeks of age. All infants were followed up for safety till 28 days after the third dose. Immune response to the vaccine, in terms of seroresponse and geometric mean concentrations, was compared across the five study groups.Results: Increase in anti-rotavirus serum IgA antibodies from baseline, demonstrated higher immune response for all the three antigen concentrations of BRV-TV vaccine and RotaTeq in comparison with the placebo. Sero-response rates for placebo, BRV-TV dose-levels 10(5.0) FFU, 10(5.8) FFU, 10(6.4) FFU, and Rotateq at 28 days post third dose were 11.1%, 27.8%, 41.2%, 83.3%, and 63.2% respectively using the four-fold or more criteria. The BRV-TV vaccine arm corresponding to the highest antigen concentration of 10(6 4) FFU had a higher sero-response rate compared to the active comparator arm (RotaTeq), 28 days post each vaccine dose. The safety profile was comparable across the treatment groups.Conclusions: Overall, the results showed that all three doses of BRV-TV vaccine were safe, well tolerated and displayed good immunogenicity (dose-response) in healthy Indian infants. (C) 2014 Published by Elsevier Ltd.