Safety and immunogenicity from a phase I trial of inactivated severe acute respiratory syndrome coronavirus vaccine

Antivir Ther. 2007;12(7):1107-13.

Abstract

Background: Emergence of severe acute respiratory syndrome (SARS) from the winter of 2002 to the spring of 2003 has caused a serious threat to public health.

Methods: To evaluate the safety and immunogenicity of the inactivated SARS coronavirus (SARS-CoV) vaccine, 36 subjects received two doses of 16 SARS-CoV units (SU) or 32 SU inactivated SARS-CoV vaccine, or placebo control.

Results: On day 42, the seroconversion reached 100% for both vaccine groups. On day 56, 100% of participants in the group receiving 16 SU and 91.1% in the group receiving 32 SU had seroconverted. The geometric mean titre of neutralizing antibody peaked 2 weeks after the second vaccination, but decreased 4 weeks later.

Conclusion: The inactivated vaccine was safe and well tolerated and can elicit SARS-CoV-specific neutralizing antibodies.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Viral / biosynthesis*
  • Antibodies, Viral / immunology
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Neutralization Tests
  • SARS Virus / immunology*
  • Severe Acute Respiratory Syndrome / immunology*
  • Severe Acute Respiratory Syndrome / therapy*
  • Severe Acute Respiratory Syndrome / virology
  • Vaccination
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / immunology
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*

Substances

  • Antibodies, Viral
  • Vaccines, Inactivated
  • Viral Vaccines