Li Zhang1, Mingwei Wei2, Pengfei Jin2, Jingxin Li1,2, Fengcai Zhu1,3. 1. Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, PR China. 2. Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China. 3. NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention.
Abstract
Background: The test-negative design has been used widely in evaluation of various vaccines' effectiveness, such as influenza, rotavirus, and so on. Recently, there have been some studies about EV-71 vaccine effectiveness by using test-negative design(TND). However, the validity of the TND application in EV-71 vaccines has not been evaluated. Methods: This study is set upon prior methods to evaluate the validity of TND for influenza vaccine by using a randomized controlled clinical trial database. Vaccine effectiveness estimated by TND (VE-TND) in modified intention-to-treat population (mITT) and per-protocol-set population(PPS) was derived from a large randomized placebo-controlled clinical trial (RCT) of inactivated monovalent EV-71 vaccine in China. Derived VE-TND estimates were compared to the original vaccine efficacy results in RCT (VE-RCT). Results: We totally enrolled 7325 participants who seeked medical care for suspected EV-71 infected diseases during the surveillance. There are no significant differences between cases(test-positive) and controls(test-negative) on sex, age, height, and weight. TND vaccine effectiveness estimates were similar to original RCT vaccine efficacy estimates, both in modified intention-to-treat population and per-protocol populations.Conclusions: This study supports that TND, as an appropriate observational study design is valid to measure EV-71 vaccine effectiveness.
Background: The test-negative design has been used widely in evaluation of various vaccines' effectiveness, such as influenza, rotavirus, and so on. Recently, there have been some studies about EV-71 vaccine effectiveness by using test-negative design(TND). However, the validity of the TND application in EV-71 vaccines has not been evaluated. Methods: This study is set upon prior methods to evaluate the validity of TND for influenza vaccine by using a randomized controlled clinical trial database. Vaccine effectiveness estimated by TND (VE-TND) in modified intention-to-treat population (mITT) and per-protocol-set population(PPS) was derived from a large randomized placebo-controlled clinical trial (RCT) of inactivated monovalent EV-71 vaccine in China. Derived VE-TND estimates were compared to the original vaccine efficacy results in RCT (VE-RCT). Results: We totally enrolled 7325 participants who seeked medical care for suspected EV-71 infected diseases during the surveillance. There are no significant differences between cases(test-positive) and controls(test-negative) on sex, age, height, and weight. TND vaccine effectiveness estimates were similar to original RCT vaccine efficacy estimates, both in modified intention-to-treat population and per-protocol populations.Conclusions: This study supports that TND, as an appropriate observational study design is valid to measure EV-71 vaccine effectiveness.
Authors: Huiying Chua; Shuo Feng; Joseph A Lewnard; Sheena G Sullivan; Christopher C Blyth; Marc Lipsitch; Benjamin J Cowling Journal: Epidemiology Date: 2020-01 Impact factor: 4.822