An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

Hum Vaccin Immunother. 2016 Dec;12(12):3079-3088. doi: 10.1080/21645515.2016.1221872.

Abstract

This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection.

Keywords: DNA vaccine; Genital herpes; HSV-2; codon-modification; healthy volunteers; polynucleotide vaccine; ubiquitination.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Antibodies, Viral / blood
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • Herpes Simplex / prevention & control*
  • Herpes Simplex Virus Vaccines / administration & dosage
  • Herpes Simplex Virus Vaccines / adverse effects*
  • Herpes Simplex Virus Vaccines / immunology*
  • Herpesvirus 2, Human / immunology*
  • Humans
  • Injections, Intradermal
  • Leukocytes, Mononuclear / immunology
  • Male
  • Vaccines, DNA / administration & dosage
  • Vaccines, DNA / adverse effects*
  • Vaccines, DNA / immunology*
  • Young Adult

Substances

  • Antibodies, Viral
  • Herpes Simplex Virus Vaccines
  • Vaccines, DNA