A Phase 1 Vaccine Study in Healthy and Chronic Hep B Participants
Research type
Research Study
Full title
A Phase 1 Monotherapy Study to Evaluate the Safety Tolerability and Immunogenicity of Vaccination with Candidate Chimpanzee Adenovirus-vectored Hepatitis B Virus Vaccine (ChAdOx1-HBV) in Healthy Participants and Participants with Chronic Hepatitis B infection
IRAS ID
269777
Contact name
Tom Evans
Contact email
Sponsor organisation
Vaccitech Ltd
Eudract number
2019-003420-20
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Hepatitis B currently infects more than 240 million people worldwide and is associated with the development of liver cancer, liver failure and liver cirrhosis. Although drug treatments are available these are prolonged and do not get rid of the HBV virus. Our aim is develop a therapeutic vaccine that will cure people of HBV infection after chronic (long term) HBV infection is established.
Researchers at the University of Oxford in collaboration with the company Vaccitech, have developed a novel candidate vaccine against HBV. A part of the HBV virus has been inserted into the carrier viruses Chimpanzee Adenovirus (ChAdOx1). To date ChAdOx1 have been shown to have an excellent safety record. These kinds of vaccines have been given to hundreds of healthy volunteers and are now being tested for effectiveness in other infectious diseases and cancer.
In this study we are hoping to increase the immune response against the HBV virus. We will do this by inserting both part of the HBV genome into the vaccine and also a genetic adjuvant (truncated class-II invariant gene). In animal studies, this approach has been shown to be safe and to significantly enhance the immune response against HBV.
During this study 10 healthy adults and 12 volunteers infected with HBV (on anti-viral drugs to suppress the HBV virus), aged 18-65 years, will receive one intramuscular injection of vaccine. All participants will be followed up for up to 6 months (9 visits in total) and will be asked to give a blood sample at each clinic visit.
The aims of the study are to assess the safety of the vaccine and to see if the vaccine can induce a strong immune response against the hepatitis B Virus.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0419
Date of REC Opinion
28 Nov 2019
REC opinion
Further Information Favourable Opinion