This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

“I want to bring more hope to my partner, my family, and everyone who has been affected by HSV-2.” – hero #85

Trial ID: Moderna HSV
Help move the future of herpes simplex virus type 2 (HSV-2) genital herpes forward by participating in the Vantage Trial for an investigational vaccine.

About the Vantage Trial

The Vantage Trial will look at the safety and immune response of an investigational vaccine in healthy adults with HSV-2 genital herpes.

The investigational vaccine being evaluated is a messenger RNA (mRNA) vaccine. mRNA vaccines aim to teach the body how to make a specific protein(s) that may potentially help your immune system prevent or treat certain diseases. The investigational vaccine in this clinical trial, mRNA-1608, aims to reduce the recurrence of outbreaks and how much the virus sheds in people with HSV-2.

Estimated Enrollment

300 Participants

Phase

1/2

Who Can Join?

You will have to meet other criteria to join.

Participants must:

This clinical trial is looking for adult participants. To join, you must:

  • Be 18 to 55 years of age
  • Be in good health
  • Have been diagnosed with HSV-2 genital herpes at least 1 year prior to the screening visit
  • Have had 3 to 9 symptomatic genital herpes recurrences within the 12 months before the screening visit (or, if currently on suppressive therapy, prior to the start of that therapy)
  • Be willing to stop taking suppressive antiviral therapy during the trial and not take episodic antiviral therapy during three 28-day periods
  • Not be pregnant or planning on becoming pregnant for at least 3 months following your final injection visit

Participants must not:

-

See if You are Eligible

What Is HSV-2 Genital Herpes

HSV-2 is a very common virus that causes the sexually transmitted disease genital herpes.

About 12% of people in the U.S. are living with HSV-2.1

Males* are more likely to pass HSV-2 on to their partners.2,3 HSV-2 is also more common in the non-Hispanic African American community than in White, Asian, and Mexican-American communities.4

*Those assigned male at birth.

During the first episode, or outbreak, of symptoms after infection, people may experience:

  • Painful bumps, blisters, or sores around the genitals or rectum
  • Difficulty urinating
  • Headache
  • Flu-like symptoms
  • Neurological complications

An outbreak is an active period of recurring symptoms. People who have recurring symptoms of HSV-2 will continue to experience bumps, blisters, or sores that may be painful and itchy.

HSV-2 Treatment

Currently, the only treatment options are antiviral medications that are given as episodic or suppressive therapy.

  • Episodic antiviral therapy aims to shorten how long symptoms stick around during an outbreak
  • Daily suppressive therapy is intended to prevent recurring outbreaks and lower the risk of passing HSV-2 to sexual partners—but it does not remove the risk completely. In a study where people with HSV-2 took daily suppressive therapy for 8 months, transmission was only reduced by 48%.6 Some daily therapies could also have side effects that discourage people from taking them regularly

While some vaccines aim to prevent a disease, others are therapeutic in nature and work to treat infections after they’ve already occurred. Moderna is currently evaluating an investigational therapeutic vaccine to potentially treat HSV-2, which would be the first of its kind if approved. An investigational vaccine is a vaccine not yet approved by a country’s drug regulatory agency.

Find a Location Near You

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
DM Clinical Research - Tomball
Status
Not yet Recruiting

See if You are Eligible

Your participation may help advance research of an investigational treatment option for HSV-2 genital herpes-one that aims to treat genital herpes and relieve the burden of daily medication.

Explore more information about HSV-2 symptoms.

How to Recognize HSV-2 Symptoms

Symptoms of HSV-2 can vary greatly, especially between your first symptoms after infection and recurring symptoms. During your first symptoms after infection, you may have experienced flu-like symptoms, such as fever, body aches, or swollen glands, and neurologic complications, such as pain, “pins-and-needles” sensation, and constipation. You also may have experienced painful genital lesions, blisters, and sores, as well as other symptoms listed below.

How to Recognize HSV-2 Symptoms

Recurring symptoms are typically less severe and less painful.

Genital lesions, blisters, and sores

Itching

Painful urination

Swollen lymph nodes

What to Expect

Participation in the Vantage Trial will last for about 15 months. During the clinical trial, you will:

  • Have at least 10 scheduled trial visits and 12 scheduled phone calls or telehealth visits to check in on you
  • Complete electronic diary (eDiary) entries regularly
  • Collect 2 swabs per day from the genital and anal (called anogenital) area for three 28-day periods to measure viral shedding
  • Swab kits and supplies will be provided
  • Additional swabbing and visits may be necessary if symptoms occur

Dive into the full schedule of events.

Enrolling in this clinical trial is completely your choice. You may stop participation in the trial at any time, and you do not have to give a reason for doing so. Qualified participants will receive payment for their trial-related time and travel.

Transmission Risks

Because the virus reactivates and sheds in the body frequently (even when symptoms aren’t present), HSV-2 genital herpes can be passed on to others:

  • Through sores during an active period of symptoms
  • From skin-to-skin contact while a person is symptomatic
  • or asymptomatic

Reduce the risk of transmission by:

  • Not having sex during an active period of symptoms
  • Using condoms while asymptomatic

If you are pregnant, there is a risk of passing HSV-2 to the baby in the uterus or during birth.3

References

  1. Centers for Disease Control and Prevention. Genital herpes – CDC detailed fact sheet. Updated July 22, 2021. Accessed November 17, 2022. https://www.cdc.gov/std/herpes/stdfact-herpes- detailed.htm
  2. Bernstein DI, Bellamy AR, Hook EW, et al. Epidemiology, clinical presentation, and antibody response to primary infection with herpes simplex virus type 1 and type 2 in young women. Clin Infect Dis. 2013;56(3):344-351. doi:10.1093/cid/cis891
  3. Xu F, Sternberg MR, Kottiri BJ, et al. Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States. JAMA. 2006;296(8):964-973. doi:10.1001/jama.296.8.964
  4. McQuillan G, Kruszon-Moran D, Flagg EW, Paulose-Ram R. Prevalence of herpes simplex virus type 1 and type 2 in persons aged 14-49: United States, 2015-2016. NCHS Data Brief. 2018;(304):1-8.
  5. Mertz GJ, Benedetti J, Ashley R, Selke SA, Corey L. Risk factors for the sexual transmission of genital herpes. Ann Intern Med. 1992;116(3):197-202. doi:10.7326/0003-4819-116-3-197
  6. Corey L, Wald A, Patel R, et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med. 2004;350(1):11-20. doi:10.1056/NEJMoa035144

What is HSV part 2

HSV-2 can be passed by direct contact with sores. But keep in mind that people with HSV-2 can pass on the virus to partners even if they don’t have any symptoms.

HSV-2 is a very common virus that causes the sexually transmitted disease genital herpes.

In a study, 69% of new cases of genital herpes resulted from contact with an asymptomatic sexual partner.5

HSV-2 is passed by the virus shedding on the skin and genitals at various times.

  • For those who are asymptomatic, HSV-2 shedding occurs on about 10% of days1
  • For those who are symptomatic, shedding occurs on about 20% of days1

Find the answers you’re seeking with our trial overview.

Find the answers you’re seeking
with our trial overview CONTENT

For more information on what counts as a recurrence, check out our HSV-2 Symptom Infographic below.