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Gskvx000000008866

This article discusses clinical trials investigating the use of GSKVx000000008866, a novel drug candidate, for the treatment of chronic hepatitis B (CHB). These trials aim to assess the safety, efficacy, and immune response of GSKVx000000008866 alone or in combination with other therapies in patients with CHB who are already on nucleos(t)ide analogue (NA) therapy. The studies explore different dosing regimens and administration methods to determine the most effective approach for managing this persistent viral infection.

Table of Contents

Overview of GSKVX000000008866

GSKVX000000008866 is an investigational therapeutic vaccine being developed by GlaxoSmithKline Biologicals for the treatment of chronic hepatitis B (CHB)[1]. This vaccine is designed to stimulate the immune system to fight against the hepatitis B virus (HBV) in patients who are already infected and on stable nucleos(t)ide analogue (NA) therapy[2].

Mechanism of Action

The vaccine works through a novel approach combining different components:

  1. Viral vector vaccines: These include ChAd155-hIi-HBV (an adenovirus-based vector) and MVA-HBV (a modified vaccinia Ankara-based vector). These vectors are designed to deliver HBV antigens to stimulate the immune system[1].
  2. Adjuvanted protein vaccines: These contain HBc (hepatitis B core) and HBs (hepatitis B surface) antigens combined with an adjuvant called AS01B-4. Adjuvants help enhance the immune response to the vaccine[1].

This combination approach aims to induce both antibody and T-cell responses against HBV, potentially leading to better control or clearance of the virus[2].

Clinical Trials

GSKVX000000008866 is currently being studied in clinical trials to evaluate its safety, efficacy, and immune response in patients with chronic hepatitis B. Two notable studies include:

  1. A Phase I/II trial (Study TH HBV VV-001) evaluating different dosing regimens and combinations of the viral vector and adjuvanted protein vaccines[1].
  2. A Phase II trial (Study TH HBV ASO-001) investigating the sequential treatment of an antisense oligonucleotide (ASO) followed by GSKVX000000008866[2].

Potential Efficacy

The clinical trials aim to assess the efficacy of GSKVX000000008866 through several key measures:

  • Reduction in hepatitis B surface antigen (HBsAg) levels
  • HBsAg loss and seroconversion (development of antibodies against HBsAg)
  • Suppression of HBV DNA levels
  • Induction of HBV-specific immune responses

The goal is to achieve a sustained virologic response (SVR), defined as HBsAg levels below the lower limit of quantification and undetectable HBV DNA[2]. This could potentially lead to functional cure of chronic hepatitis B.

Safety Profile

The safety of GSKVX000000008866 is being closely monitored in clinical trials. Key safety assessments include:

  • Occurrence of adverse events (AEs) and serious adverse events (SAEs)
  • Injection site reactions (such as redness, pain, and swelling)
  • Systemic reactions
  • Laboratory abnormalities
  • Potential immune-mediated disorders (pIMDs)

As with any investigational treatment, patients should be aware that unexpected side effects may occur[1][2].

Administration

GSKVX000000008866 is administered as an intramuscular injection. The exact dosing schedule and number of injections may vary depending on the specific regimen being studied. In some trials, it is given as a series of injections over several months[1][2].

Future Prospects

If successful in clinical trials, GSKVX000000008866 could potentially offer a new therapeutic option for patients with chronic hepatitis B. The goal is to achieve better control of the virus and possibly even functional cure, which would be a significant advancement in the treatment of this chronic infection[1][2].

It’s important to note that GSKVX000000008866 is still in the investigational stage, and more research is needed to fully understand its efficacy and safety profile. Patients with chronic hepatitis B should continue to follow their current treatment plans and consult with their healthcare providers about potential new therapies.

Aspect Details
Study Type Phase I/II and Phase II clinical trials
Participant Profile Adults (18-65 years) with chronic hepatitis B on stable nucleos(t)ide analogue therapy
Intervention GSKVx000000008866 alone or in combination with other investigational therapies
Administration Intramuscular injection
Primary Objectives Safety, efficacy, and immune response assessment
Key Efficacy Measures HBsAg reduction, HBsAg loss, anti-HBs seroconversion, HBV DNA suppression
Safety Monitoring Adverse events, laboratory abnormalities, serious adverse events
Immunogenicity Assessment Anti-HBc and anti-HBs antibodies, HBV-specific T-cell responses
Duration Variable, with long-term follow-up for safety and efficacy

FAQ

  • What is GSKVx000000008866? GSKVx000000008866 is an investigational drug being studied for the treatment of chronic hepatitis B. It is part of a new class of therapies aimed at improving outcomes for patients with this persistent viral infection.
  • Who is eligible to participate in these clinical trials? Generally, adults aged 18-65 with chronic hepatitis B who are stable on nucleos(t)ide analogue therapy are eligible. Specific criteria include having HBV DNA levels below 90 IU/mL and HBsAg levels above 100 IU/mL. Patients should not have cirrhosis or other significant liver conditions.
  • What are the main goals of these clinical trials? The primary objectives are to evaluate the safety, efficacy, and immune response of GSKVx000000008866 alone or in combination with other therapies. Researchers are looking at factors such as reduction in HBsAg levels, HBsAg loss, and development of anti-HBs antibodies.
  • How is the drug administered in these trials? GSKVx000000008866 is administered as an intramuscular injection. Some trials are testing it alone, while others are combining it with other investigational therapies in various dosing schedules.
  • What are the potential benefits and risks of participating? Potential benefits include improved control of hepatitis B infection and possible reduction in viral markers. Risks may include injection site reactions, systemic side effects, and unknown long-term effects. All participants will be closely monitored for safety throughout the trials.

Ongoing Clinical Trials on Gskvx000000008866

  • Study on the Safety and Effectiveness of GSKVX000000008866 and GSKVX000000009151 in Adults with Chronic Hepatitis B on Nucleotide Analogue Therapy

    Not recruiting

    1
    Investigated drugs:
    Belgium Germany Spain

  • Study on Safety and Efficacy of Bepirovirsen and Drug Combination for Chronic Hepatitis B in Patients on Nucleos(t)ide Analogue Therapy

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Italy Poland +2

Glossary

  • Chronic Hepatitis B (CHB): A long-lasting liver infection caused by the hepatitis B virus that can lead to serious liver damage if left untreated.
  • Nucleos(t)ide analogue (NA) therapy: A type of antiviral medication used to suppress hepatitis B virus replication in patients with chronic infection.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus that is used as a marker of active infection.
  • Anti-HBs: Antibodies against the hepatitis B surface antigen, which typically indicate recovery from infection or successful vaccination.
  • HBeAg: Hepatitis B e antigen, a viral protein that indicates active viral replication.
  • HBV DNA: The genetic material of the hepatitis B virus, measured to assess viral load and treatment response.
  • Cirrhosis: Severe scarring of the liver caused by long-term liver damage, which can be a complication of chronic hepatitis B.
  • Fibrosis: The formation of scar tissue in the liver due to chronic inflammation or injury.
  • FibroScan: A non-invasive test that measures liver stiffness to assess the degree of liver fibrosis.
  • Alpha-fetoprotein (AFP): A protein produced by liver tumors, used as a marker for hepatocellular carcinoma screening in chronic hepatitis B patients.
  • Sustained Virologic Response (SVR): A measure of treatment success, typically defined as undetectable HBV DNA and/or HBsAg loss after a specified period following treatment completion.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • T-cells: A type of white blood cell that plays a central role in the immune response against viral infections.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-gskvx000000008866-and-gskvx000000009151-in-adults-with-chronic-hepatitis-b-on-nucleotide-analogue-therapy/
  2. http://clinicaltrials.eu/trial/study-on-safety-and-efficacy-of-bepirovirsen-and-drug-combination-for-chronic-hepatitis-b-in-patients-on-nucleostide-analogue-therapy/