【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）

英文研究报告 2020年05月25日 12:14 管理员

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.