Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design.
Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design.
复制标题
DOI：
10.1016/j.vaccine.2016.10.077
复制
发表时间：
2017-01-03
期刊：
影响因子：
5.5
通讯作者：
Victor JC
中科院分区：
文献类型：
--
作者：
Schwartz LM;Halloran ME;Rowhani-Rahbar A;Neuzil KM;Victor JC
轮状病毒疫苗（RV）最近已在低收入环境中引入。RV有效性的准确引入后监测很重要。测试阴性设计（TND）用于测量RV有效性。在撒哈拉以南非洲和亚洲使用RV随机试验评估TND。TND是衡量低收入环境中RV有效性的适当方法。检测阴性设计（TND）是目前用于测量轮状病毒疫苗（RV）有效性的流行病学方法，比较了符合急性胃肠炎预定义病例定义的轮状病毒阳性病例和轮状病毒阴性对照的疫苗接种状态。尽管在低收入环境中使用了该研究设计，但尚未对TND进行评估以衡量轮状病毒疫苗的有效性。本研究基于先前的方法，使用随机对照临床试验数据库评估TND用于流感疫苗的使用。试验阴性疫苗有效性（VE-TND）估计值来自撒哈拉以南非洲和亚洲的单价（RV 1）和五价（RV 5）轮状病毒疫苗的三项大型随机安慰剂对照试验（RCT）。将推导的VE-TND估计值与原始RCT疫苗有效性估计值（VE-RCT）进行比较。TND的核心假设（即，轮状病毒疫苗对轮状病毒阴性腹泻没有作用）。TND疫苗有效性估计值几乎等同于原始RCT疫苗有效性估计值。RV对轮状病毒阴性腹泻无实质性影响。这项研究支持TND作为一个适当的流行病学研究设计，以衡量轮状病毒疫苗在低收入环境中的有效性。
Rotavirus vaccines (RVs) have been recently introduced in low-income settings. Accurate post-introduction monitoring of RV effectiveness is important. The test-negative design (TND) is used to measure RV effectiveness. The TND was evaluated using randomized trials of RV in sub-Saharan Africa and Asia. The TND is an appropriate method to measure RV effectiveness in low-income settings. The test-negative design (TND), an epidemiologic method currently used to measure rotavirus vaccine (RV) effectiveness, compares the vaccination status of rotavirus-positive cases and rotavirus-negative controls meeting a pre-defined case definition for acute gastroenteritis. Despite the use of this study design in low-income settings, the TND has not been evaluated to measure rotavirus vaccine effectiveness. This study builds upon prior methods to evaluate the use of the TND for influenza vaccine using a randomized controlled clinical trial database. Test-negative vaccine effectiveness (VE-TND) estimates were derived from three large randomized placebo-controlled trials (RCTs) of monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in sub-Saharan Africa and Asia. Derived VE-TND estimates were compared to the original RCT vaccine efficacy estimates (VE-RCTs). The core assumption of the TND (i.e., rotavirus vaccine has no effect on rotavirus-negative diarrhea) was also assessed. TND vaccine effectiveness estimates were nearly equivalent to original RCT vaccine efficacy estimates. Neither RV had a substantial effect on rotavirus-negative diarrhea. This study supports the TND as an appropriate epidemiologic study design to measure rotavirus vaccine effectiveness in low-income settings.
登录
查看更多内容
影响因子：
168.9
作者：
Armah, George E.;Sow, Samba O.;Neuzil, Kathleen M.
通讯作者：
Neuzil, Kathleen M.
影响因子：
5.5
作者：
Jackson, Michael L.;Rothman, Kenneth J.
通讯作者：
Rothman, Kenneth J.
影响因子：
11.8
作者：
Tate, Jacqueline E.;Ngabo, Fidele;Parashar, Umesh D.
通讯作者：
Parashar, Umesh D.
影响因子：
5.5
作者：
Foppa, Ivo M.;Haber, Michael;Shay, David K.
通讯作者：
Shay, David K.
DOI：
10.1136/bmj.f3726
发表时间：
2013-06-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Patel MM;Patzi M;Pastor D;Nina A;Roca Y;Alvarez L;Iniguez V;Rivera R;Tam KI;Quaye O;Bowen M;Parashar U;De Oliveira LH
通讯作者：
De Oliveira LH