NCT04297917

First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection

A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Barinthus Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.

Detailed description

This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine was given to participants in a dose escalation strategy (two doses). Five healthy participants was administered the low dose first (cohort 1). Dose escalation was only initiated in the next 5 healthy participants (cohort 2) following Safety Monitoring Committee (SMC) review. Six CHB participants was administered the low dose (cohort 3) before the dose escalation was initiated in the remaining 5 CHB participants (cohort 4). Twenty-six healthy participants (15 who have received two doses of AZD1222 \[cohort 5\] and 11 who have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine \[cohort 6\]) were dosed in parallel with the high dose used in cohorts 2 and 4. Each participant received 1 dose of the vaccine (intramuscular injection). Participants (Volunteers \& patients) in cohorts 1 to 4 attended up to 9 study visits and cohorts 5 \& 6 attended up to 4 visits in total. The last visit was 24 weeks after vaccination for cohorts 1 to 4 and 12 weeks for cohorts 5 \& 6.

Conditions

• Hepatitis B
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1-HBV	chimpanzee adenovirus-vectored hepatitis B virus vaccine

Timeline

• Start date: 2019-02-10
• Primary completion: 2022-05-23
• Completion: 2022-06-26
• First posted: 2020-03-06
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

4 sites across 1 country: United Kingdom