Important Information
Please note, we need you to ….
- Read the important documents for this study
- If you are interested, look at the dates that this study is being run (cohort visit planners) and reply to our email (don’t re-register online) to let us know which cohort(s) you are available for
- We will ring you to check your suitability and provide further information about the study
- We will make you a screening appointment at NZCR Auckland. You will need to attend at the scheduled time if you wish to take part in the study
Study Information
Hepatitis B virus (HBV) infection is associated with increased risks for chronic liver inflammation, a condition known as Chronic Hepatitis B (CHB). CHB is a global condition that can result in severe liver disease, liver cancer, or even death. Current treatments for CHB can suppress the infection and disease in many patients, however, these treatments rarely cure the virus and therefore need to be taken as life-long therapy. Very few patients have any lasting benefit if they stop taking the current standard of care therapy.
GS-2829 and GS-6779 are viral vector vaccines. Viral vector vaccines use a modified, harmless version of a virus (the vector) that contains instructions for making a protein that will be recognised by the immune system as foreign. In the case of the GS-2829 and GS-6779 vaccines, the viral vector enters the cells and expresses HBV proteins, causing the immune system to attack any HBV-infected cells.
GS-2829 and GS-6779 cannot reproduce and cannot cause HBV infection or any other viral infections. The vaccine cannot alter a person’s DNA (genetic material).
Ultimately, GS-2829 and GS-6779 will be used to treat CHB by clearing the virus from the body, with the hope of providing a functional cure for CHB.
The purpose of this study is to:
- Evaluate how safe and well tolerated multiple doses of GS-2829 and GS-6779 are in healthy participants (Part 1a) and in participants with CHB (Part 1b).
- Measure the body’s response to a single and multiple doses of GS-2829 and/or GS-6779 in healthy participants (Part 1a) and in participants with CHB (Part 1b).
- Assess the body’s immune response to GS-2829 and/or GS-6779.
Study Candidates
- Healthy males and females
- Aged 18 – 60 years
- BMI equal to or less than 32 kg/m2
- No current use of any medication.
What is Involved?
Cohort 8:
- Study Visits: 17 visits and 12 phone calls
(0 inpatient stay, 6 of 17 visits will be full day 8-10 hours long) - Reimbursement update: $7,000 total (less tax)
Important Documents
Important documents to download and read
Please read through the documents thoroughly and check that the dates work for you.