TH HBV VV-001 (204852)
Research type
Research Study
Full title
A first-time-in human (FTIH), Phase I, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety immunogenicity and efficacy of GSK Biologicals’ HBV viral vector vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tides analogues (NA) therapy.
IRAS ID
_260120
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2017-001452-55
Duration of Study in the UK
4 years, 0 months, 7 days
Research summary
The burden of chronic Hepatitis B virus (HBV) infection constitutes a public health threat in many areas of the world. Currently, there are two main treatment options for chronic hepatitis B (CHB) patients: either by pegylated interferon alpha (PegIFNα) or by nucleo(s)tide analogues (NA). These treatments must be continued indefinitely or the Hepatitis B Virus would spread again. Currently there is no cure for Hepatitis B virus infection.
This is a GSK Sponsored phase 1, first time in patient study to investigate the safety of the Hepatitis B Virus vaccines and understand how well the vaccines are tolerated. The study will also look at how well the vaccine triggers the body to produce antibodies and immune cells that are capable of killing Hepatitis B Viruses to see if patients could safely discontinue their regular medication without the HBV coming back.
The study will be conducted globally and will include 148 adults aged 18-65. In the UK, this study will be run at hospital sites and 20-25 patients will be included. The study will last around 841 days and patients would need to visit the clinic at least 27 times . Four vaccinations will be given around 56 days apart at visits 1, 6, 10 and 14. Since this is the first time the HBV vaccines are being given to people, the study will be conducted in 3 steps (steps A, B and C) to make sure that patients are safe when taking part. Reviews of safety information will happen at different points in the steps to make sure the patients are safe. In this study, 2 different doses (low and high) of the ChAd155-hIi-HBV vaccine, 2 different doses (low and high) of the MVA-HBV vaccine, 2 different doses (low and high) of HBc-HBs/AS01B-4 and placebo will be given in specific combinations that start with the lowest doses. In each step, there will be 3 arms with different combinations of the vaccines (separately (Step A and B) or together (Step C). In step A (15 patients) there is a placebo arm and patients will have a 1 in 3 chance of being assigned to that arm (5 patients). Step B also has 1 arm where 2 doses of placebo will be administered, followed by the high dose ChAd155-hIi-HBV vaccine and then high dose MVA-HBV vaccine. There is a 1 in 4 chance that the patient will be assigned to that arm. Step C has no placebo arm.
Other study procedures performed during the study include blood sampling, physical examination, urine tests, pregnancy testing (if applicable), cheek (buccal) swab, Fibroscan, Liver ultrasound, and electrocardiogram.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0334
Date of REC Opinion
2 Apr 2019
REC opinion
Unfavourable Opinion