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

2 1

What is this study about?

This clinical trial is focused on studying the treatment of Chronic Hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The study involves testing new vaccines developed by GlaxoSmithKline Biologicals S.A. These vaccines are given as a series of shots, known as a prime-boost schedule, to help the body build a stronger immune response. The vaccines being tested include the HBV viral vector vaccines and an adjuvanted proteins therapeutic vaccine known as GSK3528869A. These vaccines are designed to work together to improve the body’s ability to fight the hepatitis B virus.

The purpose of the study is to evaluate the safety and effectiveness of these vaccines in adults aged 18 to 65 who have Chronic Hepatitis B and are already receiving treatment with medications called nucleos(t)ide analogues, which help control the virus. Participants will receive the vaccines through injections into the muscle, and the study will monitor how their bodies react to the vaccines over time. Some participants may receive a placebo, which is a substance with no active ingredients, to compare the effects of the vaccines.

Throughout the study, participants will have regular check-ups to assess their health and the vaccines’ impact on their immune system. The study will look at how well the vaccines help the body produce antibodies, which are proteins that fight infections, and how they affect specific immune cells. The study will also track any side effects or health changes that occur after receiving the vaccines. The trial is expected to continue until October 2025, providing valuable information on the potential benefits and safety of these new vaccines for people with Chronic Hepatitis B.

1 Initial Vaccination

Receive the first dose of the Buffer S9b Solution as a suspension for injection. This is administered through an intramuscular injection.

The purpose of this step is to introduce the vaccine into the body to begin the process of building immunity against chronic Hepatitis B.

2 Follow-up Visits

Attend scheduled follow-up visits to monitor any reactions to the vaccine and assess overall health.

These visits are crucial for tracking the occurrence of any side effects or adverse events, such as local or general symptoms, within 7 days after each vaccination.

3 Subsequent Vaccinations

Receive additional doses of the vaccine according to the study schedule. Each dose is administered intramuscularly.

The timing and number of these doses are determined by the study protocol to ensure optimal immune response.

4 Monitoring and Assessment

Undergo regular assessments to evaluate the vaccine’s safety and effectiveness. This includes monitoring for any serious adverse events (SAEs) and medically attended events (MAEs) up to six months after the last dose.

Blood tests and other laboratory evaluations may be conducted to check for any abnormalities and to measure immune response.

5 Final Evaluation

Participate in a final evaluation to assess the long-term effects of the vaccine and the overall health status.

This step includes a comprehensive review of any adverse events, changes in health status, and the effectiveness of the vaccine in reducing Hepatitis B virus levels.

Who Can Join the Study?

Patients must be able and willing to follow the study requirements, like completing diary cards and attending follow-up visits.
Patients need to provide written informed consent before any study procedures begin.
Participants should be between 18 and 65 years old at the time of the first vaccination.
Female patients who cannot have children can join the study. This includes women who have had a hysterectomy (removal of the uterus), bilateral ovariectomy (removal of both ovaries), or are post-menopausal (no longer have menstrual periods).
Female patients who can have children may join if they have used effective birth control for 30 days before vaccination, have a negative pregnancy test at the start, and agree to continue using birth control until 12 weeks after the last vaccination.
Male patients with a documented bilateral vasectomy (surgical procedure to prevent sperm from being released) and no sperm in their semen, or those who agree to abstain from sexual intercourse or use condoms until 12 weeks after the last vaccination, can participate.
Patients must have chronic hepatitis B (CHB) and be on a specific type of medication called a nucleos(t)ide analogue for at least 24 months, with a high barrier to resistance (e.g., ETV, TDF, TAF).
Patients should have a documented history of HBeAg-negative CHB before starting the medication or for at least 24 months before the study.
Patients must have had their hepatitis B virus (HBV) under control according to local clinical diagnosis within the last 24 months, and at the screening test, their HBV DNA should be less than 10 IU/mL.
Patients should have normal levels of ALT (a liver enzyme) according to local clinical diagnosis within the last 24 months, and at the screening test, ALT should be 48 U/L or lower.
Patients should not have a clinical diagnosis of cirrhosis (severe liver scarring) within the last 24 months.
Patients should have a FibroScan TE score less than 9.6 kPa and a FibroTest score less than 0.59 at screening. If one of these scores is out of range, a liver biopsy within 12 months before screening showing mild liver damage can allow participation.
Patients should have an HBsAg concentration greater than 50 IU/mL and be negative for anti-HBs at screening.
Patients should be positive for anti-HBc at screening.
Patients should be HBeAg-negative at screening.

Who Cannot Join the Study?

Patients who are not currently taking medication to control their chronic Hepatitis B infection. This means they must be on treatment that keeps the virus under control.
Patients who have other serious health conditions that might interfere with the study. This could include other infections or diseases.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
Patients who have a history of severe allergic reactions, especially to vaccines or their components.
Patients who are participating in another clinical trial, as this could affect the results of the study.
Patients who have received another vaccine within a certain period before the study starts, as this could interfere with the study vaccine.
Patients who have a history of drug or alcohol abuse, which might affect their ability to follow the study procedures.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
SGS Belgium	Edegem	Belgium
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hflpizmc Uljjvnexmgeaf Dg Lg Ptwhmddu	Madrid	Spain
Hwckqqah Uzzoouqrycdji Memyjis Dj Vtgnqxnkhp	Santander	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	29.03.2019
Germany	Not recruiting	29.03.2019
Spain	Not recruiting	29.03.2019

Trial locations

Investigated drugs:

GSK3528869A is a therapeutic vaccine designed to help the immune system fight chronic Hepatitis B infection. It is given in a prime-boost schedule, which means it is administered in multiple doses to enhance the body’s immune response. This vaccine is used in combination with other treatments to improve its effectiveness in controlling the virus.

HBV Viral Vector Vaccines are experimental vaccines that use a viral vector to deliver parts of the Hepatitis B virus to the body. This helps the immune system recognize and fight the virus. These vaccines are given in a prime-boost schedule, which involves multiple doses to strengthen the immune response against Hepatitis B.

Nucleo(s)tide Analogue (NA) Therapy refers to a group of antiviral medications used to control chronic Hepatitis B infection. These medications work by reducing the amount of virus in the body, helping to prevent liver damage and other complications. Patients in the trial are already well-controlled on this therapy, meaning their viral levels are low and stable.

Investigated diseases:

Hepatitis B

Chronic Hepatitis B – Chronic Hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. It occurs when the virus remains in the body for more than six months, leading to ongoing liver inflammation. Over time, this can result in liver damage, including scarring (cirrhosis) and potentially liver cancer. The disease often progresses slowly, and many individuals may not experience symptoms initially. However, some may develop fatigue, abdominal pain, and jaundice as the condition advances. The virus is primarily spread through contact with infectious body fluids, such as blood or semen.

Trial ID:

2023-510020-68-00

Protocol code:

204852

NCT ID:

NCT03866187

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?