Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial Background A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain. Methods We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post- vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127. Findings Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T- cell response peaked at day 14 post-vaccination. Interpretation The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.
【 在 TravisBickle (Travis) 的大作中提到: 】 : Adenovirus疫苗，人体产生抗体和T细胞反应。 : https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/ : fulltext : Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 : vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, : first-in-human trial : Background : A vaccine to protect against COVID-19 is urgently needed. We aimed to assess : the safety, tolerability, and immunogenicity of a recombinant adenovirus : type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of : ...................
牛津那个AZD1222现在开始phase 2/3期了，猴子试验能用真病毒检验保护效果。陈将军这个是一期，之前用ferret试保护效果，不知道ferret和人多接近，为啥不用猴子。 However, in preclinical studies, seven out of eight ferrets were protected from having detectable virus copies when challenged by SARS-CoV-2 through nasal dripping 21 days after immunisation with the vaccine, whereas only one out of eight ferrets in the control group was negative for virus copies ( Wei C, unpublished).
Adenovirus疫苗，人体产生抗体和T细胞反应。
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/
fulltext
Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised,
first-in-human trial
Background
A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus
type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
Methods
We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults
aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-
vaccination. Safety was assessed over 28 days post-vaccination. Specific
antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation
and pseudovirus neutralisation tests. T-cell responses were assessed by
enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127.
Findings
Between March 16 and March 27, 2020, we screened 195 individuals for
eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days
after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%)
participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and
the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or
moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased
significantly at day 14, and peaked 28 days post-vaccination. Specific T-
cell response peaked at day 14 post-vaccination.
Interpretation
The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days
post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were
noted from day 14 post-vaccination. Our findings suggest that the Ad5
vectored COVID-19 vaccine warrants further investigation.
牛津那个也是 腺病毒?
猴的实验，不好！
【 在 TravisBickle (Travis) 的大作中提到: 】
: Adenovirus疫苗，人体产生抗体和T细胞反应。
: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/
: fulltext
: Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5
: vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, : first-in-human trial
: Background
: A vaccine to protect against COVID-19 is urgently needed. We aimed to
assess
: the safety, tolerability, and immunogenicity of a recombinant adenovirus : type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein
of
: ...................
【 在 cellcycle (vacoule) 的大作中提到: 】
: 牛津那个也是 腺病毒?
: 猴的实验，不好！
牛津那个AZD1222现在开始phase 2/3期了，猴子试验能用真病毒检验保护效果。陈将军这个是一期，之前用ferret试保护效果，不知道ferret和人多接近，为啥不用猴子。
However, in preclinical studies, seven out of eight ferrets were protected
from having detectable virus copies when challenged by SARS-CoV-2 through
nasal dripping 21 days after immunisation with the vaccine, whereas only one out of eight ferrets in the control group was negative for virus copies (
Wei C, unpublished).
这玩意根本不能只关注机理和技术是不是真有效。
儿童疫苗的技术早就证实了几十年了，中国疫苗出事少了？
生产运输零售任何环节，哪儿都有偷鸡摸狗的。
就算仅仅谈论技术，中国“砖家”的嘴脸，也未必比菏泽那个疫苗贩子可信到哪儿去。更别说陈微是为党国服务的解放军了。
算了吧。爱有用没用，倒找钱劳资也不会打中国疫苗。
打死劳资也不会用自己的生命来验证中国疫苗可信。
【 在 houge (猴哥) 的大作中提到: 】
: 这玩意根本不能只关注机理和技术是不是真有效。
: 儿童疫苗的技术早就证实了几十年了，中国疫苗出事少了？
: 生产运输零售任何环节，哪儿都有偷鸡摸狗的。
: 就算仅仅谈论技术，中国“砖家”的嘴脸，也未必比菏泽那个疫苗贩子可信
: 到哪儿去。更别说陈微是为党国服务的解放军了。
: 算了吧。爱有用没用，倒找钱劳资也不会打中国疫苗。
: 打死劳资也不会用自己的生命来验证中国疫苗可信。
这个最后得用真人测保护效果才行，牛津疫苗现在注射一万人，从2-70岁，然后统计随机感染率。真人试验不能直接把病毒滴鼻子里，要是测试对照组都感染很少无法形成统计结果就傻
b了。
中国零感染没法做了，不是听说陈将军到加拿大做临床试验了吧。
除非包子本人现场直播在路边小诊所随机打一针，否则咋测试我都不会信。
吹嘘中国制造的口罩，结果包子本人带的是美国原产的。
吹嘘中国防护品，结果美国捐助武汉医生的全被解放军截留了，陈微一身的美式装备。
算了吧。
其实这个法子对中国奶粉最有效：现场直播七个常委抱着自家的吃奶娃，随机找个小超市冲一瓶中国奶粉，坐马路牙子喂了自家娃.以后就再也没有中国奶粉不可信的破事儿
了。
常委们敢么？
【 在 TravisBickle(Travis) 的大作中提到: 】
: 这个最后得用真人测保护效果才行，牛津疫苗现在注射一万人，从2-70岁，然后统计随
: 机感染率。真人试验不能直接把病毒滴鼻子里，要是测试对照组都感染很少无法形成统
: 计结果就傻
: b了。
: 中国零感染没法做了，不是听说陈将军到加拿大做临床试验了吧。
【 在 houge (猴哥) 的大作中提到: 】
: 除非包子本人现场直播在路边小诊所随机打一针，否则咋测试我都不会信。
: 吹嘘中国制造的口罩，结果包子本人带的是美国原产的。
: 吹嘘中国防护品，结果美国捐助武汉医生的全被解放军截留了，陈微一身的美式装备。
: 算了吧。
: 其实这个法子对中国奶粉最有效：现场直播七个常委抱着自家的吃奶娃，随机找个小超
: 市冲一瓶中国奶粉，坐马路牙子喂了自家娃.以后就再也没有中国奶粉不可信的破事儿
: 了。
: 常委们敢么？
Adenovirus好像还有一个问题是容易高温失活，全程冷藏才行。陈将军这个适合发达国家用。
冷链运输在中国不是稀罕事，我以前在油管看过一个视频，山东的冷冻鸡一口气运到乌鲁木齐的。
麻烦的不是冷链运输的技术要求，而是从专家病毒所研制，到最终接种，这中间太多人偷鸡摸狗了。你谁都不敢信。
没有谁有啥credit。
说到底是中国的人不行。
估摸上帝都没辙。
【 在 TravisBickle(Travis) 的大作中提到: 】
: Adenovirus好像还有一个问题是容易高温失活，全程冷藏才行。陈将军这个适合发达国
: 家用。
【 在 houge (猴哥) 的大作中提到: 】
: 冷链运输在中国不是稀罕事，我以前在油管看过一个视频，山东的冷冻鸡一口气运到乌
: 鲁木齐的。
: 麻烦的不是冷链运输的技术要求，而是从专家病毒所研制，到最终接种，这中间太多人
: 偷鸡摸狗了。你谁都不敢信。
: 没有谁有啥credit。
: 说到底是中国的人不行。
: 估摸上帝都没辙。
中国没问题，主要是非洲南亚中美洲热带。一个中心造出来，分瓶封装，全程冷藏，接种时每人一瓶。