Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2025-12-28 @ 2:22 PM
Study NCT ID:
NCT01687595
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2012-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Sponsor:
Agenus Inc.
Organization:
Study Overview
Official Title:
A Phase 2a, Multicenter, Double-blinded, Randomized, 2-Period Trial to Evaluate the Effect of HerpV Administered in Combination With the Stimulon® Adjuvant QS-21 on Viral Shedding in Adults With Recurrent Genital Herpes
Status:
COMPLETED
Status Verified Date:
2021-06
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:
The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.
Detailed Description:
This study will evaluate the biological effectiveness and safety of the HerpV vaccine in combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be evaluated by collecting number and severity of adverse events throughout the study.
Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.
Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days.
Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.
Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.
Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days.
Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.
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?: