A test for the relative potency of herpes simplex virus vaccines based upon the female guinea-pig model of HSV 2 genital infection

J Biol Stand. 1988 Apr;16(2):109-18. doi: 10.1016/0092-1157(88)90038-8.

Abstract

An ELISA for total herpes simplex virus (HSV) 1 antigen content and a test of immunogenicity based upon the female guinea-pig model of HSV 2 genital infection were applied to two samples from batches of HSV 1 subunit ('Skinner') vaccine. The ELISA was reproducible within an approximately threefold limit of error and batches 1 and 2 were indistinguishable in antigen content. The effects of vaccination in the guinea-pig model were assessed by a statistical analysis of scores derived from the principal clinical signs, vaginal oedema and lesions on the external genitalia. The statistical power of the guinea-pig assay was such that reductions in the severity of illness approaching 40% would be significant (P less than 0.05) on 90% of occasions. The ability to make quantitative estimates of immunogenicity will prove useful in the quality control of HSV vaccine batches which are destined for clinical trials in man.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Viral / analysis
  • Antigens, Viral / analysis
  • Cytopathogenic Effect, Viral
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Guinea Pigs
  • Herpes Genitalis / microbiology
  • Herpes Genitalis / prevention & control*
  • Simplexvirus / immunology*
  • Simplexvirus / isolation & purification
  • Vagina / microbiology
  • Vero Cells
  • Viral Vaccines* / standards

Substances

  • Antibodies, Viral
  • Antigens, Viral
  • Viral Vaccines