Application of continuous wireless remote temperature monitoring system in the phase Ⅰ trial of a novel recombinant adenovirus type⁃5 vector⁃based Ebola vaccine
Objective:To introduce the application of the wireless remote temperature monitoring system in phase Ⅰ clinical trial of the new recombinant adenovirus vector Ebola vaccine,compare its sensitivity with the traditional mercury thermometer measurement,and discuss the vaccine immunization fever factors. Methods:This randomized,double-blind,placebo-controlled phase Ⅰ trial of 120 healthy subjects aged 18 to 60 years who met the inclusion criteria of Taizhou,Jiangsu Province,was conducted. Body temperature was monitored within 6 hours after the Ebola vaccination using a wireless remote temperature monitoring system while body temperature was measured daily using a conventional mercury thermometer. Results:The wireless remote temperature monitoring system continuously measured and recorded the incidence of total fever and the incidence of primary fever within 6 hours after inoculation than mercury thermometer,and the difference was statistically significant(P < 0.05). The study of influencing factors showed that high body mass index(BMI)was the protective factor of fever(OR=0.752,P=0.001). The high pre-existing antibody of pre-adenovirus type 5 was the risk factor of fever(OR=2.472,P=0.043). Conclusion:This study,for the first time,applied the wireless remote temperature monitoring system to the phase Ⅰ clinical trial of the novel recombinant adenovirus type-5 vector-based Ebola vaccine,which reduced the time interval of body temperature monitoring and found the abnormal changes of body temperature in time. To explore the factors that affect fever is conducive to the researchers to correctly explain the occurrence of fever.