Mary Wilson
Well-known member
Published:February 03, 2021
Zhiwei Wu, MSc *Yaling Hu, MSc *Prof Miao Xu, PhD *Zhen Chen, MSc *Wanqi Yang, MSc Zhiwei Jiang, PhD
Minjie Li, MSc *Hui Jin, BA *Guoliang Cui, BA *Panpan Chen, MSc *Lei Wang, MSc *Guoqing Zhao, PhD *Yuzhu Ding, BA *Prof Yuliang Zhao, MSc [SUP]†*[/SUP]Weidong Yin, MBA [SUP]†[/SUP]
DOI:https://doi.org/10.1016/S1473-3099(20)30987-7
Summary
Background
A vaccine against COVID-19 is urgently needed for older adults, in whom morbidity and mortality due to the disease are increased. We aimed to assess the safety, tolerability, and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in adults aged 60 years and older.Methods
We did a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial of CoronaVac in healthy adults aged 60 years and older in Renqiu (Hebei, China). Vaccine or placebo was given by intramuscular injection in two doses (days 0 and 28). Phase 1 comprised a dose-escalation study, in which participants were allocated to two blocks: block 1 (3 μg inactivated virus in 0?5 mL of aluminium hydroxide solution per injection) and block 2 (6 μg per injection). Within each block, participants were randomly assigned (2:1) using block randomisation to receive CoronaVac or placebo (aluminium hydroxide solution only). In phase 2, participants were randomly assigned (2:2:2:1) using block randomisation to receive either CoronaVac at 1?5 μg, 3 μg, or 6 μg per dose, or placebo. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection (which was assessed in all participants who had received the two doses of vaccine according to their random assignment, had antibody results available, and did not violate the trial protocol). Seroconversion was defined as a change from seronegative at baseline to seropositive for neutralising antibodies to live SARS-CoV-2 (positive cutoff titre 1/8), or a four-fold titre increase if the participant was seropositive at baseline. This study is ongoing and is registered with ClinicalTrials.gov(NCT04383574)
https://www.thelancet.com/journals/l...24DBno.twitter
Zhiwei Wu, MSc *Yaling Hu, MSc *Prof Miao Xu, PhD *Zhen Chen, MSc *Wanqi Yang, MSc Zhiwei Jiang, PhD
Minjie Li, MSc *Hui Jin, BA *Guoliang Cui, BA *Panpan Chen, MSc *Lei Wang, MSc *Guoqing Zhao, PhD *Yuzhu Ding, BA *Prof Yuliang Zhao, MSc [SUP]†*[/SUP]Weidong Yin, MBA [SUP]†[/SUP]
DOI:https://doi.org/10.1016/S1473-3099(20)30987-7
Summary
Background
A vaccine against COVID-19 is urgently needed for older adults, in whom morbidity and mortality due to the disease are increased. We aimed to assess the safety, tolerability, and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in adults aged 60 years and older.Methods
We did a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial of CoronaVac in healthy adults aged 60 years and older in Renqiu (Hebei, China). Vaccine or placebo was given by intramuscular injection in two doses (days 0 and 28). Phase 1 comprised a dose-escalation study, in which participants were allocated to two blocks: block 1 (3 μg inactivated virus in 0?5 mL of aluminium hydroxide solution per injection) and block 2 (6 μg per injection). Within each block, participants were randomly assigned (2:1) using block randomisation to receive CoronaVac or placebo (aluminium hydroxide solution only). In phase 2, participants were randomly assigned (2:2:2:1) using block randomisation to receive either CoronaVac at 1?5 μg, 3 μg, or 6 μg per dose, or placebo. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection (which was assessed in all participants who had received the two doses of vaccine according to their random assignment, had antibody results available, and did not violate the trial protocol). Seroconversion was defined as a change from seronegative at baseline to seropositive for neutralising antibodies to live SARS-CoV-2 (positive cutoff titre 1/8), or a four-fold titre increase if the participant was seropositive at baseline. This study is ongoing and is registered with ClinicalTrials.gov(NCT04383574)
https://www.thelancet.com/journals/l...24DBno.twitter