Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT02114060
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Sponsor:
Genocea Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: