View clinical trials related to Genital Herpes Simplex Type 2.
Filter by:This exploratory trial will have two parts. Part A is a dose escalation part and Part B is an expanded safety and dose evaluation part. Part A will focus on the safety evaluations, but vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A.
This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: - To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: - Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) - Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine - Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period - Antiviral use. - To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: - Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. - Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: - Time to first clinical and/or virologic recurrence, - Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine, - Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods. - Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: - Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. - Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following: 1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose) 2. GEN-003: Antigens alone 3. Placebo (DPBS diluent) Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows: - 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) - 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) - 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) - Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients) Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.