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G. R. B. Skinner - One of the best experts on this subject based on the ideXlab platform.
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prevention of Herpes Genitalis by the bulgarian vaccine f hsv 2v prk preliminary clinical evidence
Croatian Medical Journal, 2000Co-Authors: G. R. B. Skinner, J A Davies, S Dundarov, P AndonovAbstract:Aim To examine the antigenic properties of the formalin-inactivated Herpes simplex virus type 2 (HSV-2) virus-particle vaccine F. HSV-2V(PRK), which has been used therapeutically in Bulgaria for 30 years, and to make preliminary assessment of its potential protective efficacy by a follow-up of vaccinated patients with Herpes Genitalis. Methods Properties of the vaccine were examined by standard immunological laboratory tests. Fifty-five patients at risk of Herpes Genitalis received 2-4 vaccinations and were monitored during a 6-year follow-up. Results The vaccine was antigenic in laboratory tests and absorbed neutralizing antibody from hyperimmune rabbit serum against Herpes simplex virus type 1 (HSV-1). In vaccinated patients, there was an overall contraction rate of Herpes Genitalis of 5.4%. There was no evidence of significant local or generalized adverse effects from vaccination. Conclusion Bulgarian vaccine F.HSV-2V(PRK) may have protective efficacy, which, in association with its apparent safety from our findings and from its clinical use for over 30 years in Bulgaria, suggests that it should be scrutinized by a formal clinical trial.
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The efficacy and safety of Skinner Herpes simplex vaccine towards modulation of Herpes Genitalis; report of a prospective double-blind placebo-controlled trial
Medical Microbiology and Immunology, 1997Co-Authors: G. R. B. Skinner, M. E. Turyk, C. A. Benson, G. D. Wilbanks, P. Heseltine, J. Galpin, R. Kaufmann, L. Goldberg, C. E. Hartley, A. BuchanAbstract: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.
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chemotherapeutic and immunotherapeutic management of Herpes Genitalis
Current Obstetrics & Gynaecology, 1993Co-Authors: G. R. B. SkinnerAbstract:Treatment of virus disease is frustrated by the unique mode of virus replication and the propensity of certain viruses to establish latent disease. Viruses are obligate intracellular parasites and thus their replication can be inhibited only by agents which operate within the virus-infected cell and yet are not too toxic for administration to human subjects. These difficulties are compounded by the ability of certain viruses most typically of the Herpes virus group to establish latent disease where the virus genome or part of the virus genome becomes incorporated into the host cell genome. It is then virtually ‘inaccessible’ with the conceptual difficulty of finding a mechanism to prevent this virus DNA from transcribing new virus particles. These difficulties at the cellular molecular level are complicated, if not governed, by the significant psychological component in any genital infectious disease particularly Herpes Genitalis; this aspect has been discussed in detail in Part 1’ of this series. In general, there are three mechanisms which prevent progression of virus disease: Inhibition of replication of viruses within virusinfected cells, which is most usually effected by natural or synthetic medicinal preparations. Inhibition of release of infectious virus from virus-infected cells which is effected by humoral antibody directed against virus or host cell components.2~4 Neutralisation, de-activation or ingestion of extracellular virus by humoral antibody in conjunction with complement and/or leucocytes or by medicinal preparations during local treatment of virus lesions for example ether
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Report of twelve years experience in open study of Skinner Herpes simplex vaccine towards prevention of Herpes Genitalis
Medical Microbiology and Immunology, 1992Co-Authors: G. R. B. Skinner, J. A. Hallworth, P. Mcleish, C. Fink, J. Melling, C. Wiblin, B. Thornton, W. Gardner, C. Hartley, A. BuchanAbstract:Three hundred and forty-seven subjects at risk for Herpes Genitalis were vaccinated with Skinner vaccine, NFUAc.HSV1.(S^−MRC 5), and were followed for an average duration of 2 years representing a total consortship of 664.4 years. Based on survey information obtained during this consortship, there were estimated to be 3076 recurrences which summated to 3.5 years total duration of disease and comprised at least 6794 lesions; there were an estimated 51997 episodes of intercourse including at least 241 episodes of unprotected intercourse in the presence of herpetic lesions. The rate of contraction of Herpes Genitalis was 6 of 54 consorts (11.1%) who received one vaccination and 7 of 293 (2.4%) who received two, three of four vaccinations. There was no evidence of physical or psychological side effects from vaccination.
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a virus particle vaccine prepared from bovine mammillitis virus against Herpes Genitalis
Comparative Immunology Microbiology and Infectious Diseases, 1991Co-Authors: G. R. B. Skinner, Alexander Buchan, J Durham, J Davies, G CastrucciAbstract:Abstract A vaccine against Herpes Genitalis was prepared from the extracellular virus particles from baby hamster kidney cells infected with bovine mammillitis virus (BMV) strain “Allerton”. The virus was inactivated by formaldehyde followed by ultracentrifugation to concentrate the virus particles and eliminate formaldehyde to an acceptable concentration for immunisation of human subjects. The vaccine was cross antigenic and cross immunogenic with Herpes simplex virus type 1. Thirty-four consorts at high risk of Herpes Genitalis were immunised with two or three doses each containing 10 9 virus particles equialent to approx. 150 μg protein. There has been no evidence of local or general side effect in a follow-up period of over 100 patient years. The immunogenicity and protective efficacy of this vaccine in human subjects will be investigated in a double-blind placebo-controlled trial.
A. Buchan - One of the best experts on this subject based on the ideXlab platform.
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The efficacy and safety of Skinner Herpes simplex vaccine towards modulation of Herpes Genitalis; report of a prospective double-blind placebo-controlled trial
Medical Microbiology and Immunology, 1997Co-Authors: G. R. B. Skinner, M. E. Turyk, C. A. Benson, G. D. Wilbanks, P. Heseltine, J. Galpin, R. Kaufmann, L. Goldberg, C. E. Hartley, A. BuchanAbstract: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.
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Report of twelve years experience in open study of Skinner Herpes simplex vaccine towards prevention of Herpes Genitalis
Medical Microbiology and Immunology, 1992Co-Authors: G. R. B. Skinner, J. A. Hallworth, P. Mcleish, C. Fink, J. Melling, C. Wiblin, B. Thornton, W. Gardner, C. Hartley, A. BuchanAbstract:Three hundred and forty-seven subjects at risk for Herpes Genitalis were vaccinated with Skinner vaccine, NFUAc.HSV1.(S^−MRC 5), and were followed for an average duration of 2 years representing a total consortship of 664.4 years. Based on survey information obtained during this consortship, there were estimated to be 3076 recurrences which summated to 3.5 years total duration of disease and comprised at least 6794 lesions; there were an estimated 51997 episodes of intercourse including at least 241 episodes of unprotected intercourse in the presence of herpetic lesions. The rate of contraction of Herpes Genitalis was 6 of 54 consorts (11.1%) who received one vaccination and 7 of 293 (2.4%) who received two, three of four vaccinations. There was no evidence of physical or psychological side effects from vaccination.
Michael J Smith - One of the best experts on this subject based on the ideXlab platform.
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imiquimod 5 percent cream does not alter the natural history of recurrent Herpes Genitalis a phase ii randomized double blind placebo controlled study
Antimicrobial Agents and Chemotherapy, 2002Co-Authors: Timothy W Schacker, Marcus A. Conant, Christopher Thoming, Tamara Stanczak, Zengri Wang, Michael J SmithAbstract:Present strategies for control of Herpes Genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local Herpes antigens during a recurrence may augment Herpes simplex virus (HSV)-specific cell-mediated immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of Herpes Genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed the treatment period and 93 completed the observation period. The median times to first genital Herpes recurrence were 53 days for those receiving placebo (n = 30) and 54, 60, and 64 days for those receiving imiquimod one time per week (n = 34), two times per week (n = 32), and three times per week (n = 28), respectively. The median annualized recurrence rates during the treatment period were 3.8, 4.9, 3.2, and 3.1, respectively. There were no statistically significant differences in the time to first recurrence or in the annualized recurrence rate between the imiquimod and placebo groups in either the treatment or the observation period. A trend in increased rates of local adverse events at the application site and a delay in lesion healing with more frequent dosing suggested a pharmacologic effect. Although clinical efficacy has been observed for imiquimod in other conditions in which a TH1-type immune response may be beneficial, including other viral infections such as those caused by human papillomavirus, no apparent effect on the short-term natural history of Herpes Genitalis recurrences was observed.
Marcus A. Conant - One of the best experts on this subject based on the ideXlab platform.
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imiquimod 5 percent cream does not alter the natural history of recurrent Herpes Genitalis a phase ii randomized double blind placebo controlled study
Antimicrobial Agents and Chemotherapy, 2002Co-Authors: Timothy W Schacker, Marcus A. Conant, Christopher Thoming, Tamara Stanczak, Zengri Wang, Michael J SmithAbstract:Present strategies for control of Herpes Genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local Herpes antigens during a recurrence may augment Herpes simplex virus (HSV)-specific cell-mediated immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of Herpes Genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed the treatment period and 93 completed the observation period. The median times to first genital Herpes recurrence were 53 days for those receiving placebo (n = 30) and 54, 60, and 64 days for those receiving imiquimod one time per week (n = 34), two times per week (n = 32), and three times per week (n = 28), respectively. The median annualized recurrence rates during the treatment period were 3.8, 4.9, 3.2, and 3.1, respectively. There were no statistically significant differences in the time to first recurrence or in the annualized recurrence rate between the imiquimod and placebo groups in either the treatment or the observation period. A trend in increased rates of local adverse events at the application site and a delay in lesion healing with more frequent dosing suggested a pharmacologic effect. Although clinical efficacy has been observed for imiquimod in other conditions in which a TH1-type immune response may be beneficial, including other viral infections such as those caused by human papillomavirus, no apparent effect on the short-term natural history of Herpes Genitalis recurrences was observed.
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Recombinant alpha-2 interferon gel treatment of recurrent Herpes Genitalis.
Antiviral research, 1992Co-Authors: Mark Lebwohl, Stephen L. Sacks, Marcus A. Conant, James D. Connor, John M. Douglas, L. J. Eron, Steven Marlowe, Jack Mendelson, Virginia Chen, Patricia BradstreetAbstract:Topical recombinant alpha-2 interferon treatment of recurrent genital Herpes was studied in a randomized, double-blind, placebo controlled clinical trial. Three hundred and eighty-seven patients were treated at eight study centers with either interferon gel or placebo four times daily for four days. Interferon therapy caused a 26% decrease in the duration of viral shedding. For male patients, there were also significant decreases in the time to crusting (17%) and duration of pain (34%) and itching (21%). For patients with recurrent genital Herpes, treatment with topical interferon was found to be effective in decreasing the duration of viral shedding and, for males, pain, itching and time to crusting.
Patricia Bradstreet - One of the best experts on this subject based on the ideXlab platform.
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Recombinant alpha-2 interferon gel treatment of recurrent Herpes Genitalis.
Antiviral research, 1992Co-Authors: Mark Lebwohl, Stephen L. Sacks, Marcus A. Conant, James D. Connor, John M. Douglas, L. J. Eron, Steven Marlowe, Jack Mendelson, Virginia Chen, Patricia BradstreetAbstract:Topical recombinant alpha-2 interferon treatment of recurrent genital Herpes was studied in a randomized, double-blind, placebo controlled clinical trial. Three hundred and eighty-seven patients were treated at eight study centers with either interferon gel or placebo four times daily for four days. Interferon therapy caused a 26% decrease in the duration of viral shedding. For male patients, there were also significant decreases in the time to crusting (17%) and duration of pain (34%) and itching (21%). For patients with recurrent genital Herpes, treatment with topical interferon was found to be effective in decreasing the duration of viral shedding and, for males, pain, itching and time to crusting.