1.Introduction A vaccine clinical trial examines the effects of a vaccine on human volunteers in terms of safety,immunogenicity,and clinical efficacy through three distinct stages[1].In general,phase 1 studies focus o...1.Introduction A vaccine clinical trial examines the effects of a vaccine on human volunteers in terms of safety,immunogenicity,and clinical efficacy through three distinct stages[1].In general,phase 1 studies focus on safety and reactogenicity,while phase 2 studies attempt to establish an immunogenicity proof of dose range,dosage,and immunization procedure(sometimes even efficacy data).Large phase 3 studies are designed to evaluate whether the dosing and vaccination schedule can deliver the desired protection efficacy with an acceptable safety profile[2].A phase 3 vaccine clinical trial provides indispensable efficacy data to support a vaccine that has been issued with licensure.展开更多
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to scale up around the world, costing severe health and economic losses. The developmen...The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to scale up around the world, costing severe health and economic losses. The development of an effective COVID-19 vaccine is of utmost importance. Most vaccine designs can be classified into three camps: protein based (inactivated vaccines, protein subunit, VLP and T-cell based vaccines), gene based (DNA or RNA vaccines, replicating or non-replicating viral/bacterial vectored vaccines), and a combination of both protein-based and gene-based (live-attenuated virus vaccines). Up to now, 237 candidate vaccines against SARS-CoV-2 are in development worldwide, of which 63 have been approved for clinical trials and 27 are evaluated in phase 3 clinical trials. Six candidate vaccines have been authorized for emergency use or conditional licensed, based on their efficacy data in phase 3 trials. This review summarizes the strengths and weaknesses of the candidate COVID-19 vaccines from various platforms, compares, and discusses their protective efficacy, safety, and immunogenicity according to the published clinical trials results.展开更多
文摘1.Introduction A vaccine clinical trial examines the effects of a vaccine on human volunteers in terms of safety,immunogenicity,and clinical efficacy through three distinct stages[1].In general,phase 1 studies focus on safety and reactogenicity,while phase 2 studies attempt to establish an immunogenicity proof of dose range,dosage,and immunization procedure(sometimes even efficacy data).Large phase 3 studies are designed to evaluate whether the dosing and vaccination schedule can deliver the desired protection efficacy with an acceptable safety profile[2].A phase 3 vaccine clinical trial provides indispensable efficacy data to support a vaccine that has been issued with licensure.
文摘The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to scale up around the world, costing severe health and economic losses. The development of an effective COVID-19 vaccine is of utmost importance. Most vaccine designs can be classified into three camps: protein based (inactivated vaccines, protein subunit, VLP and T-cell based vaccines), gene based (DNA or RNA vaccines, replicating or non-replicating viral/bacterial vectored vaccines), and a combination of both protein-based and gene-based (live-attenuated virus vaccines). Up to now, 237 candidate vaccines against SARS-CoV-2 are in development worldwide, of which 63 have been approved for clinical trials and 27 are evaluated in phase 3 clinical trials. Six candidate vaccines have been authorized for emergency use or conditional licensed, based on their efficacy data in phase 3 trials. This review summarizes the strengths and weaknesses of the candidate COVID-19 vaccines from various platforms, compares, and discusses their protective efficacy, safety, and immunogenicity according to the published clinical trials results.
