Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes – Interim Analysis of 2 Randomized Clinical Trials

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Preliminary Communication
Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes – Interim Analysis of 2 Randomized Clinical Trials
Shengli Xia, BS; Kai Duan, PhD; Yuntao Zhang, PhD; et al.
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JAMA. 2020;324(10):951-960. doi:10.1001/jama.2020.15543
This interim analysis of 2 randomized trials compares adverse reactions and neutralizing antibody responses to inactivated coronavirus disease 2019 (COVID-19) vs adjuvant-only control vaccination, and compares the outcomes at varying vaccine doses among healthy adults in China.
…Conclusions and Relevance  In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration  Chinese Clinical Trial Registry Identifier: ChiCTR2000031809