Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

(HSV15 Trial)

Recruiting at 7 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sanofi Pasteur, a Sanofi Company

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi Pasteur, a Sanofi Company

Eligibility Criteria

Inclusion Criteria

For Part A and Part B, the participant is willing to refrain from using suppressive antiviral therapy starting 5 days before the first vaccination visit and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods, and up to 6 months after the second vaccination visit

You are able to attend all scheduled visits and to comply with all trial procedures.

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.

Treatment Details

Interventions

• HSV 2 Formulation 1
• HSV 2 Formulation 2
• HSV 2 Formulation 3
• HSV 2 Formulation 4
• HSV 2 Formulation 5
• HSV 2 Formulation 6
• Quality-of-Life Assessment
• Sodium Chloride 0.9%

Participant Groups

Group I: Part B (Stage 2) - Group 7 Experimental Treatment 2 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 5 Experimental Treatment 2 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 4 Experimental Treatment 3 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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 7 Experimental Treatment 2 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 5 Experimental Treatment 2 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 4 Experimental Treatment 3 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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 5 Experimental Treatment 2 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 4 Experimental Treatment 3 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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 6 Placebo Group 1 Intervention

Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2

Group XIX: Part B (Stage 2) - Group 6 Placebo Group 1 Intervention

Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2

Group XX: Part A - Group 6 Placebo Group 1 Intervention

Sodium chloride 0.9% (in both arms) at Month 0 and Month 2

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry Sponsor

Trials

10

Recruited

570+

Immune Design

Industry Sponsor

Trials

10

Recruited

570+