Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

@article{Zhang2020SafetyTA,
  title={Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial},
  author={Yanjun Zhang and Gang Zeng and Hongxing Pan and Changgui Li and Yalin Hu and Kai Chu and Weixiao Han and Zhen Chen and Rong Tang and Weidong Yin and Xin Chen and Yuansheng Hu and Xiaoyong Liu and C Y Jiang and Jing-xin Li and Minnan Yang and Yan Song and Xiangxi Wang and Qiang Gao and Fengcai Zhu},
  journal={The Lancet. Infectious Diseases},
  year={2020},
  volume={21},
  pages={181 - 192}
}

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References

SHOWING 1-10 OF 32 REFERENCES

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

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, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial.

  • B. HaoZ. Chen J. Huang
  • Medicine
    Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
  • 2019

Development of an inactivated vaccine candidate for SARS-CoV-2

Preclinical results of an early vaccine candidate called PiCoVacc, which protected rhesus macaque monkeys against SARS-CoV-2 infection when analyzed in short-term studies, support the clinical development and testing of Pi coVacc for use in humans.

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified, which support further development of this vaccine.

SARS-CoV-2 vaccines in development

The development of vaccines against SARS-CoV-2 is reviewed, including an overview of the development process, the different types of vaccine candidate, and data from animal studies as well as phase I and II clinical trials in humans.

A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity

While further studies of SARS-CoV-2 are necessary to determine immune responses, evidence from other coronaviruses can provide clues and guide future research.