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Virus Therapy
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2 (HSV15 Trial)
Phase 1
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to month 14
Summary
This trial is testing new vaccines for people with or at risk of genital herpes. The vaccines aim to boost the immune system to fight off HSV-2, reducing outbreaks and the presence of the virus.
Eligible Conditions
- Genital Herpes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening to month 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to month 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events of special interest (AESIs)
Number of participants with immediate adverse events
Number of participants with medically-attended adverse events (MAAEs)
+5 moreSecondary study objectives
Change in level of HSV 2-specific cellular immune responses
Change in serum HSV 2-antibody levels
Genital HSV recurrence
+3 moreTrial Design
20Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (Stage 2) - Group 7Experimental Treatment2 Interventions
HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group II: Part B (Stage 2) - Group 5Experimental Treatment2 Interventions
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2
Group III: Part B (Stage 2) - Group 4Experimental Treatment3 Interventions
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Group IV: Part B (Stage 2) - Group 3Experimental Treatment2 Interventions
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group V: Part B (Stage 2) - Group 2Experimental Treatment2 Interventions
HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group VI: Part B (Stage 2) - Group 1Experimental Treatment2 Interventions
HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group VII: Part B (Stage 1) - Group 7Experimental Treatment2 Interventions
HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group VIII: Part B (Stage 1) - Group 5Experimental Treatment2 Interventions
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2
Group IX: Part B (Stage 1) - Group 4Experimental Treatment3 Interventions
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Group X: Part B (Stage 1) - Group 3Experimental Treatment2 Interventions
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XI: Part B (Stage 1) - Group 2Experimental Treatment2 Interventions
HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XII: Part B (Stage 1) - Group 1Experimental Treatment2 Interventions
HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XIII: Part A - Group 5Experimental Treatment2 Interventions
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2.
Group XIV: Part A - Group 4Experimental Treatment3 Interventions
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Group XV: Part A - Group 3Experimental Treatment2 Interventions
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XVI: Part A - Group 2Experimental Treatment2 Interventions
HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XVII: Part A - Group 1Experimental Treatment2 Interventions
HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Group XVIII: Part B (Stage 1) - Group 6Placebo Group1 Intervention
Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2
Group XIX: Part B (Stage 2) - Group 6Placebo Group1 Intervention
Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2
Group XX: Part A - Group 6Placebo Group1 Intervention
Sodium chloride 0.9% (in both arms) at Month 0 and Month 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Chloride 0.9%
2016
Completed Phase 4
~49730
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry Sponsor
9 Previous Clinical Trials
550 Total Patients Enrolled
Immune DesignIndustry Sponsor
9 Previous Clinical Trials
550 Total Patients Enrolled
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
419 Previous Clinical Trials
6,110,014 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
876 Previous Clinical Trials
2,021,646 Total Patients Enrolled