HSV-2 Vaccines for Genital Herpes
(HSV15 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests six different vaccines to determine their safety and effectiveness in preventing genital herpes outbreaks caused by herpes simplex virus type 2 (HSV-2). Researchers aim to find out if the vaccines can reduce the number of virus particles in the genital area and prevent outbreaks six months after vaccination. They will compare the vaccines to a placebo (a harmless substance) to assess their effectiveness. Individuals who have had genital herpes caused by HSV-2 for at least a year and experienced between 2 and 9 outbreaks in the past year may be suitable for this trial. Participants must avoid using antiviral medications for a set period during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that experimental vaccines for herpes simplex virus type 2 (HSV-2) have been tested for safety in people. Safety data from similar experimental vaccines, such as GEN-003, indicate that these vaccines are generally well-tolerated. Most participants experienced only mild side effects, like redness at the injection site or mild flu-like symptoms.
Other studies on experimental vaccines, including HSV529 and G103, reported similar safety results. These vaccines did not cause any serious health problems in participants, leading only to mild and temporary reactions.
As this trial is in an early stage, researchers continue to collect safety data. However, the absence of serious side effects in similar studies is a positive sign. Participants should be aware of common mild effects, but serious issues are not expected based on past research.12345Why are researchers excited about this trial's treatments?
Most treatments for recurrent genital herpes caused by HSV 2 focus on antiviral medications that suppress the virus, like acyclovir, valacyclovir, and famciclovir. However, the investigational HSV 2 vaccines offer a new approach by potentially providing long-term immunity rather than temporary suppression. Researchers are excited because these vaccines aim to train the immune system to recognize and fight the virus more effectively, possibly reducing the frequency and severity of outbreaks. Additionally, these vaccines are designed to be administered alongside a saline solution, which may help in assessing their safety and efficacy. The potential for a vaccine to offer sustained protection could significantly change how we manage and prevent herpes outbreaks.
What evidence suggests that this trial's treatments could be effective for HSV-2?
This trial tests several formulations of vaccines for HSV-2 (herpes simplex virus type 2) to determine their effectiveness in reducing the virus's activity. Participants will receive different formulations, such as HSV-2 Formulation 1, 2, 3, 4, 5, or 6, in separate treatment arms. Studies have shown that some vaccines can reduce the release of the virus from the skin by up to 94%. Another study found that certain vaccines led to a 60% decrease in the occurrence of genital sores. These vaccines aim to lessen symptoms and reduce the frequency of virus release, potentially helping to manage recurring genital herpes. Overall, these early results suggest that the vaccines might effectively control HSV-2 infections.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive investigational HSV 2 vaccines or placebo at Month 0 and Month 2
Follow-up
Participants are monitored for safety and effectiveness after vaccination
Long-term monitoring
Participants are monitored for adverse events and HSV recurrence
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%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi Company
Lead Sponsor
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
Immune Design
Industry Sponsor