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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
Aged 18 to 55 years on the day of inclusion
A history of established HSV-2 infection ≥ 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to month 14
Awards & highlights

HSV15 Trial Summary

This trial is testing the safety and efficacy of different investigational vaccine regimens against HSV-2. The primary objectives are to evaluate the shedding rate of HSV DNA and the proportion of participants free of HSV genital recurrence. The secondary objectives are to compare the investigational vaccine regimens with the placebo group in terms of total number of days with genital lesion and number of recurrences.

Eligible Conditions
  • Genital Herpes

HSV15 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to attend all scheduled visits and to comply with all trial procedures.
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You are willing to refrain from using antiviral therapy to treat recurrences starting 5 days before V01 and up to 6 months after the second vaccination visit.
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You have had at least 2 HSV recurrences in the past 12 months or, if currently on suppressive therapy, 2 or more in the 12 months prior to initiation suppressive therapy.

HSV15 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in level of HSV 2-specific cellular immune responses
Change in serum HSV 2-antibody levels
Genital HSV recurrence
+3 more

HSV15 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 2) - Group 6Placebo Group1 Intervention
Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2
Group XIX: Part B (Stage 1) - 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
~49620

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
404 Previous Clinical Trials
6,057,523 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
Washington
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Other
Investigational Site Number 8400003
Investigational Site Number 8400006
Investigational Site Number 8400001
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~5 spots leftby Mar 2025