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Virus Therapy

HSV 2 Formulation 2 for Genital Herpes (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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~from screening to month 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to month 14 for reporting.

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 more
Secondary study objectives
Change in level of HSV 2-specific cellular immune responses
Change in serum HSV 2-antibody levels
Genital HSV recurrence
+3 more

Trial 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

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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
412 Previous Clinical Trials
6,095,841 Total Patients Enrolled
~4 spots leftby Sep 2025
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