Phase 1b/2a of VTP-300 with or without nivolumab in CHB
Research type
Research Study
Full title
A Phase 1b/2a, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of VTP-300 With or Without Nivolumab in Participants with Chronic Hepatitis B Infection
IRAS ID
282554
Contact name
Eleanor Barnes
Contact email
Sponsor organisation
Vaccitech Ltd
Eudract number
2020-000190-25
Duration of Study in the UK
1 years, 2 months, 16 days
Research summary
Chronic hepatitis B (CHB) is a global public health challenge on the same scale as HIV and malaria. It is estimated there are 240 million CHB infection carriers with over 686,000 disease related deaths per year worldwide. Once CHB is established, inflammation and ongoing liver damage is apparent leading to cirrhosis and hepatocellular carcinoma. Current vaccines are ineffective once the infection is established; available treatments suppress, but don’t cure, the disease indicating an unmet medical need.
The sponsor is conducting this research study to evaluate the safety, tolerability and effectiveness of the combination of two therapeutic vaccines with or without nivolumab (an approved cancer treatment) in the treatment of CHB infection. Both vaccines are not yet approved. One is Chimpanzee Adenovirus-vectored Hepatitis B Virus Vaccine (ChAdOx1-HBV); the second is Modified Vaccine Ankara vectored Hepatitis B Virus Vaccine (MBA-HBV). This study will evaluate how each participant’s immune response against the Hepatitis B infection (the body’s defence mechanism) is stimulated by the study vaccines.
This is a Phase 1b/2a, multicentre study of ChAdOx1-HBV and MVA-HBV vaccines (VTP-300), with or without nivolumab. It is planned to conduct the study at up to 14 centres, in 64 male and female participants chronically infected with Hepatitis B Infection who are taking approved anti-HBV treatment (so are “virally suppressed”). Individual participation will last up to 10.5 months (1.5 months for screening and 9 months on the study - vaccines are given on Day 0 and Day 28). This is the first time that the combination of the ChAdOx1-HBV and MVA-HBV vaccines will be given to humans; there will be four different treatment groups comparing different treatment combinations. Participants will be allocated the next sequential treatment number.
Research Summary:
Immunogenicity A robust immune response to HBV antigens was induced and was highest in the VTP-300 alone group.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0225
Date of REC Opinion
26 May 2020
REC opinion
Favourable Opinion