@article{e6674b818d044cf68a0ed94e67668506,
title = "The efficacy and safety of Skinner herpes simplex vaccine towards modulation of herpes genitalis; Report of a prospective double blind placebo controlled trial",
abstract = "A randomised, placebo-controlled, multi-centre trial of intracellular subunit herpes simplex virus (HSV) type 1 vaccine NFU.Ac.HSV-1(S-)MRC (Skinner vaccine) was conducted at three medical centres in the United States. Subjects with documented herpes genitalis of at least 1-year duration and a history of six or more genital HSV recurrences in the 12 months prior to study entry were randomised to receive vaccine or placebo at 0, 1 and 2 months. Vaccination induced significant neutralising, enzyme-linked immunosorbent assay and lymphocyte transformation response to HSV-1 antigen. The frequency of recurrences was reduced in the vaccinated female patients at both 3 and 6 months following vaccination with an overall reduction in patients of both sexes which did not reach statistical significance. Recurrence severity was reduced as measured by decreased number of lesions and associated symptoms per recurrence (P = 0.04). The data suggest that clinical manifestations of latent HSV genital infection may be modified by therapeutic immunisation.",
keywords = "Clinical trial, Herpes simplex virus, Intracellular, Subunit, Vaccine",
author = "Skinner, {G. R.B.} and Turyk, {M. E.} and Benson, {C. A.} and Wilbanks, {G. D.} and P. Heseltine and J. Galpin and R. Kaufman and L. Goldberg and Hartley, {C. E.} and A. Buchan",
note = "Funding Information: Acknowledgements The authors acknowledge Sue Leurgans, Ph.D. for statistical advice; Benjamin Frank, Margaret Hosken, Jack Hawkins and Jeanne Olson for assistance with immunological assays virus cultures and data entry; Wendy Gardner, Tess Cook and Jacqueline Pawlak for secretarial support and Elizabeth Nagel, R.N., Elizabeth Egan R.N., Elizabeth Bartman, R.N., and Carolyn Alexander, R.N. for nursing support. This study was reviewed and approved by the Institutional Review Board at each participating institution. Informed consent was obtained from all study subjects and the study was conducted in accordance with the guidelines of the U.S. Department of Health and Human Services for the conduct of human experimentation in clinical research. This study was supported by a grant from Porton International, Inc., 727 Fifteenth Street N.W., Washington, D.C., Dr. G.R.B. Skinner and Dr. A. Buchan hold a proprietary interest in the development of the vaccine preparation evaluated in this study. Copyright: Copyright 2007 Elsevier B.V., All rights reserved.",
year = "1997",
doi = "10.1007/s004300050043",
language = "English (US)",
volume = "186",
pages = "31--36",
journal = "Medical Microbiology and Immunology",
issn = "0300-8584",
publisher = "Springer Verlag",
number = "1",
}