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GSKVX000000030825

Clinical trials are studying GSKVX000000030825 in people with herpes simplex and in healthy adults. These studies look at safety, side effects after each dose, immune response, and whether the treatment can help prevent recurrent genital herpes. The trials include healthy participants aged 18-40 years and participants aged 18-60 years with recurrent genital herpes.

Table of contents

Trial overview

The available trial for GSKVX000000030825 is Phase 1/2 and was designed to study reactogenicity, safety, immune response, and efficacy in herpes simplex.[1]

The study was completed and enrolled 515 participants.[1]

The trial focused on people with herpes simplex, especially those with recurrent genital herpes, and also included healthy participants.[1]

Who the studies include

The study included healthy participants aged 18-40 years and participants aged 18-60 years with recurrent genital herpes.[1]

This means the trial looked at both people without the condition and people who already had repeat genital herpes episodes.[1]

What the trials measure

The trial measured solicited administration site events, which are expected local reactions after a dose, such as redness, pain, and swelling within 7 days after each dose.[1]

It also measured solicited systemic events, which are whole-body reactions such as fever, fatigue, headache, muscle pain, and joint pain within 7 days after each dose.[1]

Another endpoint was unsolicited adverse events, meaning any unwanted health problem reported within 28 days after each dose.[1]

The study also tracked medically attended events, serious adverse events, and potential immune-mediated disorders from the first dose up to 12 months after the last study intervention.[1]

Blood and chemistry tests were checked for haematological and biochemical laboratory abnormalities after doses in both parts of the study.[1]

For efficacy, the study measured time to first confirmed HSV-2 recurrent genital herpes episode.[1]

Trial design and comparison groups

The study was interventional, which means participants received study products rather than only being observed.[1]

The intervention list included GSKVX000000030825, GSKVX000000030810, GSKVX000000030918, and NaCl solution, all given by intramuscular use in the trial record.[1]

The brief summary states that the main aim was to evaluate the reactogenicity and safety of the HSVTI, and in Part II to show efficacy in reducing confirmed HSV-2 recurrent genital herpes episodes.[1]

What the results may mean for patients

These trials are important because they do not only ask whether GSKVX000000030825 may help reduce herpes recurrences, but also whether it can be given safely.[1]

By measuring local reactions, whole-body symptoms, lab changes, and longer-term serious events, the study gives a broad safety picture.[1]

By measuring the time to the first confirmed HSV-2 recurrence, the study also looks at whether the treatment may delay the next outbreak in people with recurrent genital herpes.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05298254 Phase 1/2 Herpes Simplex; recurrent genital herpes Completed 515

FAQ

  • What is being studied in trials of GSKVX000000030825? The trials study reactogenicity, safety, immune response, and efficacy. Reactogenicity means the short-term reactions after a dose, such as redness, pain, or swelling at the injection site.
  • Who can take part in these trials? The study includes healthy participants aged 18-40 years and participants aged 18-60 years with recurrent genital herpes. The exact group depends on the part of the study.
  • What phase is the GSKVX000000030825 trial? This is a Phase 1/2 trial. That means it looks at early safety information and also starts to study whether the treatment may work.
  • What condition is being studied? The main condition is herpes simplex, especially recurrent genital herpes caused by HSV-2. The study looks at whether GSKVX000000030825 can reduce confirmed recurrent episodes.
  • What results are the trials measuring? The trials measure local and whole-body reactions, unwanted side effects, major medical events, serious adverse events, lab test changes, and time to the first confirmed HSV-2 recurrent genital herpes episode. These results help show safety and possible benefit.

Ongoing Clinical Trials on GSKVX000000030825

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Estonia Germany Spain

Glossary

  • Herpes simplex: A viral infection that can cause sores or recurrent outbreaks. In these trials, the focus is on genital herpes.
  • Recurrent genital herpes: Genital herpes that comes back again after earlier episodes. The study checks whether GSKVX000000030825 can delay or reduce these repeat episodes.
  • HSV-2: A type of herpes simplex virus linked to genital herpes. The trials measure confirmed HSV-2 recurrent genital herpes episodes.
  • Phase 1/2: An early stage of clinical research. Phase 1 mainly checks safety, and Phase 2 begins to look more closely at whether the treatment may help.
  • Interventional study: A study where participants receive a treatment or comparison product, rather than only being observed.
  • Reactogenicity: Short-term reactions after treatment, such as redness, pain, or swelling where the injection was given.
  • Adverse event (AE): Any unwanted health problem that happens during the study, whether or not it is caused by the study treatment.
  • Serious adverse event (SAE): A serious medical problem during the study, such as one that causes hospital care, major disability, or is life-threatening.
  • Medically attended event (MAE): A health event that leads to medical care or attention.
  • Potential immune-mediated disorder (pIMD): A condition that may involve the immune system attacking the body. The trial watches for newly diagnosed or worsening events of this kind.
  • Laboratory abnormality: A blood test result that is outside the normal range. The study checks blood and chemistry tests after doses.
  • Time-to-first confirmed episode: The time from the first study dose until the first confirmed herpes recurrence. This shows how long it takes before a new episode happens.

References