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

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, HIV, Hepatitis B, others

Compensation: Varies

Number of Visits: 2

24 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires participants to stop using suppressive antiviral therapy and antiviral therapy to treat recurrences starting 5 days before the first vaccination and up to 6 months after the second vaccination.

What data supports the effectiveness of the HSV 2 Formulation treatments?

Research suggests that developing a vaccine for HSV-2 could significantly reduce the number of new infections and the overall prevalence of the virus, potentially decreasing the risk of HIV transmission as well. Mathematical models indicate that both prophylactic and therapeutic HSV-2 vaccinations could substantially lower infection rates and provide a cost-effective intervention to prevent genital herpes. ^{1 2 3 4 5}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi Pasteur, a Sanofi Company

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive investigational HSV 2 vaccines or placebo at Month 0 and Month 2

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination

14 months

Multiple visits (in-person and virtual)

Long-term monitoring

Participants are monitored for adverse events and HSV recurrence

6 months after the second vaccination

What Are the Treatments Tested in This Trial?

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%

How Is the Trial Designed?

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+

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Biologic interactions between HSV-2 and HIV-1 and possible implications for HSV vaccine development. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

New insights on interactions between HIV-1 and HSV-2. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Age-specific prevalence of herpes simplex viruses in Melbourne. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Herpes simplex virus hepatitis in infants: clinical outcomes and correlates of disease severity. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Epidemiological Impact of Novel Preventive and Therapeutic HSV-2 Vaccination in the United States: Mathematical Modeling Analyses. [2020]