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

NCT04297917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-08-12

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

ChAdOx1-HBV

chimpanzee adenovirus-vectored hepatitis B virus vaccine

Sponsors & Collaborators

  • Barinthus Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Eleanor Barnes, Prof · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-10
Primary Completion
2022-05-23
Completion
2022-06-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297917 on ClinicalTrials.gov