42nd Annual International Herpesvirus Workshop, Ghent, Belgium, July 29 - August 2, 2017
- GEN-003, a Genital Herpes Immunotherapy, Showed Significant Reduction in Viral Shedding and Lesion Rates in a Phase 2b Study Interim Analysis
- GEN-003 Immunotherapy Significantly Reduced the Viral Shedding Rate in a Phase 2b Genital Herpes Clinical Trial
- GEN-003, a herpes simplex virus immunotherapy, elicits significant neutralizing antibody and cellular responses in HSV-2 seropositive subjects
- Reducing Variability of High-Throughput Herpes Simplex Virus Neutralization Assays by Utilizing an Assay-Ready Cell Line and Overlay Techniques
IDWeek 2016, New Orleans, Louisiana, October 26-30, 2016
- Functional Antibody Responses to GEN-003, a Herpes Simplex Virus Immunotherapy that Durably Reduces Viral Shedding up to 12 Months Post Dosing
41st Annual International Herpesvirus Workshop, Madison, Wisconsin, July 23-27, 2016
- The Therapeutic HSV-2 Vaccine GEN-003 Elicits Increased Humoral Responses in Seropositive Subjects
- Optimization of a Granzyme B ELISPOT Assay to Measure Cytotoxic T Lymphocyte Responses in a Herpes Simplex 2 Vaccine Clinical Trial
- Development and Characterization of a Multiplex PCR Assay for Simultaneous Quantification of Herpes Simplex Virus 1 and 2 in Anogenital Swab Samples
- Systemic Immune Responses Induced After Immunization with HSV-2 Antigens Serve as Surrogates for Responses in the Murine Genital Tract
- GEN-003 Immunotherapy Shows Potential as a Prophylactic Vaccine Candidate for Genital Herpes in Guinea Pigs
American Society of Microbiology’s ASM Microbe 2016, Boston, June 19, 2016
- GEN-003, a Therapeutic Vaccine for Genital Herpes, Significantly Reduces Viral Shedding and Lesions for at Least 6 Months
Infectious Disease Society of America’s IDWeek 2015TM, San Diego, October 9, 2015
- GEN-003 Phase 2 Interim Results: Therapeutic Vaccine for Genital Herpes Significantly Reduces Viral Shedding and Genital Lesions
40th Annual International Herpesvirus Workshop, Boise, Idaho, July 25-29, 2015
- Development and Qualification of a Real-Time PCR Assay for the Quantitative Detection of HSV-2 DNA in Anogenital Swabs
- GEN-003 HSV-2 Immunotherapy Reduces HSV-2 Shedding Equivalently in HSV-1 Seropositive and Seronegative Individuals
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Copenhagen, Denmark, April 25-29, 2015
- Both HSV-2 and HSV-1 Neutralizing Antibody Titers are Boosted in HSV-1/2 Seropositive Subjects when Vaccinated with GEN-003,a Novel HSV-2 Immunotherapy
Infectious Disease Society of America’s IDWeek 2014TM, Philadelphia, October 11, 2014
39th Annual International Herpesvirus Workshop, Kobe, Japan July 19-23, 2014
- An Enzyme-Based Antibody-Dependent Cell-Mediated Cytotoxicity Assay (ADCC): Measuring the Functional Antibody Responses to an HSV-2 Therapeutic Vaccine
- Human T cell and Antibody Responses to GEN-003, a Novel HSV-2 Therapeutic Vaccine
World Vaccine Congress 24-26 March, 2014
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Denver CO, September 10-13, 2013
David I Bernstein et al. doi:10.1093/infdis/jix004
GEN-003, a novel therapeutic vaccine for HSV-2 currently in clinical development was shown to have an acceptable safety profile, reduce viral shedding, reduce the frequency of genital lesions and boost the humoral and cellular immune responses to HSV-2.
Immune responses elicited by the GEN-003 candidate HSV-2 therapeutic vaccine in a randomized controlled dose-ranging phase 1/2a trial
Jessica Baker Flechtner et al. doi:10.1016/j.vaccine.2016.09.001
This article describes the T cell and antibody responses that were elicited in subjects who participated in the GEN-003-001 clinical trial.
Development of a high-throughput β-Gal-based neutralization assay for quantitation of herpes simplex virus-neutralizing antibodies in human samples
Amy Baccari et al. doi:10.1016/j.vaccine.2016.05.033
The NIAID held a workshop in 2012 to discuss the challenges that face the development of herpes simplex vaccines. One recommendation was harmonization and standardization of assays, including the HSV antibody neutralization assay. Conventional plaque reduction assays can be very subjective and therefore not reproducible between laboratories. To answer that call, this paper describes the development of a colorimetric HSV neutralization assay that is less subjective than plaque assays, is more high throughput, and importantly, results in concordant data across different laboratories and with disparate HSV colorimetric neutralizing antibody assays.
Johanna K. Kaufmann, Jessica. B. Flechtner. Current Opinion in Virology 17 (2016) 80-86
In this article, we review vaccine approaches for genital herpes that currently show pre-clinical and clinical promise. Technologic improvements in antigen discovery and growing understanding of immune responses to HSV-2 have driven the evolution of design of effective immunotherapies. Here, we outline the conceptual progress in vaccine development, the current state of immunotherapies, and novel approaches that may improve the efficacy of next generation vaccines.
Summary and recommendations from a National Institute of Allergy and Infectious Diseases (NIAID) workshop on “Next Generation Herpes Simplex Virus Vaccines”
David M. Knipe et al. Vaccine 32 (2014) 1561-1562
Identification of novel virus-specific antigens by CD4+ and CD8+ T cells from asymptomatic HSV-2 seropositive and seronegative donors
Long, D et al. (2014) Virology 464-465: 296-311.
The white blood components called T cells have been identified as a critical contributors to human immunity against HSV-2 disease and reactivation. This article describes the use of ATLAS™ to identify protein targets of T cell responses that are associated with natural protection in human subjects exposed to or infected with HSV-2. First, the ATLAS™ library generation and validation is described, followed by a comparison of the similarities and differences in CD4+ and CD8+ T cell responses between individuals who are infected and fail to control their disease, who are infected but do not have symptomatic outbreaks, or who are exposed through an infected partner but do not become infected. The results provide evidence that antibodies are insufficient for natural control of disease and that T cell responses to a subset of protein targets (antigens) are over-represented in people who naturally control their disease. In addition, there are some preliminary data that suggest the specificity, and not necessarily the breadth of response, is a key to prevention of infection.
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An adjuvanted herpes simplex virus 2 subunit vaccine elicits a T cell response in mice and is an effective therapeutic vaccine in Guinea pigs
Skoberne, M et al. (2013) J Virol 87(7): 3930-42
This paper summarizes the preclinical characterization of the immunotherapeutic vaccine, GEN-003, for which a phase 1/2a clinical trial has been initiated. This is the first publication showing that antigens identified through ATLAS™ screening of an HSV-2 proteomic library using T cells from HSV-2-infected or -exposed human subjects protect guinea pigs against herpes reactivation when administered as a therapeutic vaccine. The article goes on to demonstrate that in addition to dramatic reduction of symptomatic disease, there is a statistically significant reduction in the frequency of viral shedding in immunized animals.