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Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Herpes Simplex, specifically investigating a new targeted immunotherapy treatment called HSVTI. The research involves testing this treatment in two groups: healthy individuals aged 18-40 years and people aged 18-60 years who have recurrent genital herpes. The treatment is given as an intramuscular injection, and some participants will receive a placebo instead of the active treatment.

The purpose of this research is to evaluate how well people tolerate the treatment, assess its safety, measure the immune system response, and determine how effective it is at reducing episodes of genital herpes. The study will compare the new treatment to placebo to understand if it can help reduce the frequency of herpes outbreaks in people with recurring infections.

During the study, participants will receive multiple doses of either the study treatment or placebo. They will need to keep track of any symptoms in an electronic diary and attend follow-up visits. The researchers will monitor participants for any side effects at the injection site (such as redness or pain) and general body reactions (such as fever or tiredness). Blood samples will be collected to check how the immune system responds to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and eligibility

    A blood test will be performed to check your HSV-2 (herpes simplex virus type 2) status and confirm you are HIV negative

    Your medical history will be reviewed and a physical examination will be conducted

    For Part I: You must be between 18-40 years old and HSV-2 negative

    For Part II: You must be between 18-60 years old with confirmed HSV-2 and history of genital herpes for at least 1 year

  2. Step 2

    First dose administration

    You will receive an injection in your muscle (intramuscular injection)

    Blood samples will be collected before the injection

    You will need to monitor and record any injection site reactions (redness, pain, swelling) for 7 days

    You will need to monitor and record any general symptoms (fever, fatigue, headache, muscle pain, joint pain) for 7 days

  3. Step 3

    First follow-up period

    Blood tests will be performed on day 8 and day 29 after the first injection

    Any health issues will be monitored for 28 days after the injection

  4. Step 4

    Second dose administration

    A second muscle injection will be given

    Similar monitoring of injection site reactions and general symptoms will be required for 7 days

  5. Step 5

    Extended follow-up period

    Blood tests will be performed according to your study part schedule

    Part I participants: Tests on day 64, day 209, and day 394 after second dose

    Part II participants: Tests on day 57 after second dose

    Health monitoring will continue for 12 months after the last injection

Who can join the trial?

15 criteria

  • You must be willing and able to follow all study requirements, including completing electronic diaries and attending follow-up visits
  • You must provide written informed consent before any study procedures begin
  • You must be tested and confirmed negative for HIV (Human Immunodeficiency Virus)
  • For women who can become pregnant:
    • Must use highly effective birth control for one month before starting the study
    • Must have negative pregnancy tests at screening and before each treatment
    • Must agree to continue birth control throughout the study period
    • For Part I participants:
      • Must be healthy based on medical history and physical examination
      • Must be between 18 and 40 years old
      • Must test negative for HSV-2 (Herpes Simplex Virus Type 2)
      • For Part II participants:
        • Must be between 18 and 60 years old
        • Must test positive for HSV-2 through laboratory testing
        • Must have been diagnosed with genital herpes for at least 1 year
        • Must have had 3-9 outbreaks in the past 12 months
        • Must not have significant health problems
        • For Part II shedding sub-group participants:
          • Must complete at least 45 out of 56 required anogenital swabs during the baseline period

Who cannot join the trial?

14 criteria

  • People under 18 or over 65 years of age
  • History of immunodeficiency (weakened immune system) or immunosuppressive therapy
  • Individuals who received any vaccine within 30 days before the study
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials
  • History of severe allergic reactions to vaccines
  • Active autoimmune disease (condition where immune system attacks healthy cells)
  • Chronic use of medications that affect immune system
  • History of malignancy (cancer) within the past 5 years
  • Severe chronic medical conditions that are not well controlled
  • Blood disorders or conditions affecting blood clotting
  • Active infection requiring treatment
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study compliance
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Investigated drugs

Based on the provided trial information, there appears to be one main investigational therapy: HSV-targeted immunotherapy (HSVTI) is a treatment designed to target the Herpes Simplex Virus (HSV). This therapy aims to help the immune system respond to HSV infections. It is being studied both in healthy people and in people who experience recurring genital herpes. The therapy is being tested to see if it is safe to use and if it can reduce the frequency of genital herpes outbreaks in people who have recurring episodes.

What is already known about the treatment

HSVTI (HSV-targeted immunotherapy) - An investigational therapeutic vaccine administered through injection that is currently being studied in clinical trials for the treatment of Herpes Simplex Virus (HSV) infections, particularly recurrent genital herpes. This immunotherapy is designed to stimulate the immune system to recognize and fight against the herpes virus, potentially reducing the frequency and severity of outbreaks. The medication belongs to the class of immunotherapeutic agents and works by targeting specific components of the HSV virus to enhance the body's natural immune response. Currently in Phase I/II clinical trials, this treatment is being evaluated for both its safety profile in healthy individuals and its therapeutic efficacy in patients with recurrent genital herpes.

Investigated diseases

Herpes Simplex - A viral infection caused by the herpes simplex virus (HSV) that creates small, painful blisters on the skin or mucous membranes. The virus exists in two main types: HSV-1, which typically affects the oral region, and HSV-2, which usually affects the genital area. After initial infection, the virus remains dormant in nerve cells and can reactivate periodically, causing recurring outbreaks. During an outbreak, patients may experience tingling or burning sensations before blisters appear, followed by the formation of fluid-filled blisters that can break open and form sores. The virus spreads through direct contact with infected areas, particularly during active outbreaks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-510571-37-00Protocol code215336Estimated enrolment515 patientsSponsorGlaxoSmithKline Biologicals

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