ChAdOx 1-HBV, a new drug for hepatitis B under research, was completed at the end of phase I and was intramuscular injection.
The actual research date of this study is 20 19 February 10, the first release date is March 6, 2020, and the last update release date is July 8, 2020, which was developed by Vaccitech. Simply put, this is a study to evaluate the safety of ChAdOx 1-HBV vaccine (clinical trial number: NCT042979 17). In this study, 10 healthy volunteers and 12 patients with chronic hepatitis B virus (who used antiviral drugs to inhibit HBV virus), aged from 18 to 65, received 10 intramuscular injections of the study drug.
All subjects will be followed up for up to 6 months (***9 follow-ups), and blood samples will be collected during each outpatient follow-up. This phase I study mainly evaluates the safety of ChAdOx 1-HBV vaccine developed by Oxford University and its derivative company Vaccitech, and observes whether it can induce a strong immune response against hepatitis B virus. Only 22 subjects were included in phase I, and this study is also the first registered scientific study on the use of therapeutic hepatitis B vaccine (ChAdOx 1- 1HBV) for hepatitis B virus-infected people.
The design of phase I trial is as follows: providing chadox 1- 1 hepatitis B vaccine to the subjects with the strategy of increasing dose (two doses). Objective To recruit healthy volunteers (n= 10) and adult patients with chronic hepatitis B virus infection (n= 12) to receive antiviral drugs, whether tenofovir or entecavir, and to carry out continuous virological control. Each subject will receive 1 dose of vaccine (intramuscular injection). Subjects (healthy volunteers and chronic virus-infected people) will participate in the follow-up of 9 studies.
Queue 2- healthy volunteers-high dose vaccine -5 subjects; Group 3- subjects with chronic hepatitis B virus infection-low dose -6 subjects; Cohort 4- Subjects with chronic hepatitis B virus infection-High dose -6 subjects. Previously, Fan Xiao Health had publicized the new drug ChAdOx 1-HBV, which was originally a chimpanzee adenovirus vector hepatitis B virus vaccine. This is a phase I monotherapy study, which aims to evaluate the safety, tolerance and immunogenicity of ChAdOx 1-HBV vaccination in healthy subjects and patients with chronic hepatitis B virus infection.
Conclusion of Fan Xiao Health: ChAdOx 1-HBV intramuscular injection, phase I is mainly completed in healthy volunteers and HBV-infected people. Original comments by researchers from Oxford University and its derivative company Vaccitech: This is the first time that humans have studied the use of ChAdOx 1-HBV vaccine for hepatitis B virus infected people; Definition of hepatitis B virus infection: receiving antiviral drugs (tenofovir or entecavir) and obtaining continuous virological control. In this study (Phase I), the therapeutic hepatitis B vaccine (ChAdOx 1-HBV) was developed by Oxford University and its derivative company Vaccitech. Phase I clinical trial was completed on October 30th, 2020/KLOC-0.