title: The early-onset febrile reaction following vaccination and associated factors: An exploratory sub-study based on the Ebola vaccine clinical trial.
abstract: A phase-1 clinical trial aimed to assess the safety and immunogenicity of the type-5 adenovirus vector based Ebola vaccine (Ad5-EBOV) was conducted in China. To provide more evidence for the safety evaluation and dose-selection, an exploratory sub-study using a wireless automatic temperature measuring platform was done based on the phase-1 clinical trial. The main aim of the sub-study was to obtain more information about the occurrence of fever and detect the potential associated factors, second was to assess the feasibility of the temperature measuring platform in vaccine clinical trials. Temperature data of 3 treatment groups all presented a rising tendency during the first 6 hours after vaccination, the incidence of elevated temperature and possible associated factors were analyzed. For the incidence of elevated temperature, no marked dose-response relationship was found in 6 hours with wireless thermometers; the information from mercury thermometers showed that the grade-1 fever proportion peaked at 6 hours and there was no difference between groups, while grade-2 fever proportion peaked at 24 hours and was significantly higher in high-dose group than those in the other 2 groups. Significant differences were found between sex groups (males vs. female, incidence rate ratios (IRR) = 2.93 and 7.62 for any-grade, grade-2 fever respectively, P<0.001); a decline in grade-2 fever incidence was found with the increasing age groups (IRR = 0.78, P = 0.003) and body mass index (BMI, IRR = 0.67, P<0.001) .Our findings show that the dose-dependent manner between fever and the dose of Ad5-EBOV in this study might emerge after 6 hours, and which is slight and transient. Wireless thermometers secured on the skin surface are not suitable for a long time (longer than 6 hours) measurement, new methods for temperature monitoring, like ear temperature measurement, should be tested in the further research.
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Qigang
authors.initials: Q
authors.lastname: Dai
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Liang
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Yuemei
authors.initials: Y
authors.lastname: Hu
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Fanyue
authors.initials: F
authors.lastname: Meng
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Jingxin
authors.initials: J
authors.lastname: Li
authors.affiliation: b Beijing Institute of Biotechnology , Beijing , China.
authors.forename: Lihua
authors.initials: L
authors.lastname: Hou
authors.affiliation: c TOSHONG Technology Co., Ltd , Nanjing , China.
authors.forename: Hailong
authors.initials: H
authors.lastname: Zhou
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Kai
authors.initials: K
authors.lastname: Chu
authors.affiliation: d Taixing Center for Disease Control and Prevention , Taizhou , China.
authors.forename: Xiaokui
authors.initials: X
authors.lastname: Hu
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Rong
authors.initials: R
authors.lastname: Tang
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Wenjuan
authors.initials: W
authors.lastname: Wang
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Jialei
authors.initials: J
authors.lastname: Hu
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Haodi
authors.initials: H
authors.lastname: Huang
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Li
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Shuqi
authors.initials: S
authors.lastname: Yang
authors.affiliation: a Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , China.
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D004311:Double-Blind Method; D046129:Ebola Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D005260:Female; D005334:Fever / Q000139:chemically induced* / Q000453:epidemiology*; D019142:Hemorrhagic Fever, Ebola / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D046129:Ebola Vaccines
keywords: Ebola vaccine; Febrile reaction; Wireless automatic temperature measuring platform; phase-1clinical trial