【英文】柳叶刀报告：陈薇团队疫苗试验结果报告：能诱导免疫反应（11页）

The sponsors of the study participated in study design,  but had no role in data collection, data analysis, data  interpretation, or writing of the report. All authors  had full access to all the data in the study and had  final responsibility for the decision to submit for  publication. Results Between March 16 and March 27, 2020, we screened  195 individuals for eligibility. Of them, 108 were sequentially enrolled and assigned to receive the low dose  (n=36 [33%]), middle dose (n=36 [33%]), or high dose  (n=36 [33%]) of the Ad5 vectored COVID-19 vaccine  (appendix p 2). All participants completed the vaccination  and the scheduled visits within 28 days. Baseline  characteristics of the participants were similar across the  treatment groups (table 1). 87 (81%) of 108 participants reported at least one adverse  reaction within the first 7 days after the vaccination:  30 (83%) in the low dose group, 30 (83%) in the middle  dose group, and 27 (75%) in the high dose group (table 2).  No significant difference in the overall number of adverse  reactions across the treatment groups was observed.

The  most common injection site adverse reaction was pain,  which was reported in 58 (54%) vaccine recipients. Pain  was reported in 17 (47%) participants in the low dose  group, 20 (56%) participants in the middle dose group,  and 21 (58%) participants in the high dose group. The  most commonly reported systematic adverse reactions  overall were fever (50 [46%]), fatigue (47 [44%]), headache  (42 [39%]), and muscle pain (18 [17%]). Fever was reported  in 15 (42%) participants in the low dose group,  15 (42%) participants in the middle dose group, and  20 (56%) participants in the high dose group. Headache  was reported in 14 (39%) participants in the low dose  group, 11 (31%) participants in the middle dose group, and  17 (47%) participants in the high dose group. Muscle pain  was reported in seven (19%) participants in the low dose  group, three (8%) participants in the middle dose group,  and eight (22%) participants in the high dose group. Most  adverse reactions were mild or moderate in severity.  Nine participants (two [6%] in the low dose group,  two [6%] in the middle dose group, and five [14%] in the  high dose group) had an episode of severe fever (grade 3)  with axillary temperature greater than 38·5°C. Of them,  one (3%) from the high dose group reported severe fever  along with severe symptoms of fatigue, dyspnoea, and  muscle pain. One participant in the high dose group  reported severe fatigue and joint pain (appendix p 3).  These reactions occurred within 24 h post-vaccination, and  persisted for no more than 48 h. We found no significant  difference in the incidences of adverse reactions or overall  adverse events among the dose groups. High pre-existing  Ad5 immunity (titre of >1:200 vs ≤1:200) was associated  with significantly fewer occurrences of fever post-vaccination (odds ratio 0·3, 95% CI 0·1–0·6; appendix p 4).  No serious adverse event was reported within 28 days.  At day 7 after vaccination, nine (8%) participants had mild  to moderate total bilirubin increase, ten (9%) had alanine  aminotransferase increase, and four (4%) had fasting  hyperglycaemia (appendix p 5), but no instances were  considered as clinically significant.