CompletedPhase 1

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

United Kingdom47 participantsStarted 2019-02-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult males or females aged ≥18 to ≤65 years at screening
. Body Mass Index ≤30 kg/m2
. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
. If female, willing not to become pregnant up to 8 weeks after last dose of study vaccine, not breast feeding
. If female: Not pregnant, and one of the following:
. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Safety and Reactogenicity Events: Adverse Events

Timeframe: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)

Incidence of Safety and Reactogenicity Events: Serious Adverse Events

Timeframe: From day 0 to up to 6 months

Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions

Timeframe: From day 0 to day 3

Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions

Timeframe: From day 0 to day 3

Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry

Timeframe: Baseline, Day 14, 28, 56, 84

Trial details

NCT IDNCT04297917

SponsorBarinthus Biotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-23

Results submitted2023-06-26

View on ClinicalTrials.gov More Hepatitis B trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult males or females aged ≥18 to ≤65 years at screening
. Body Mass Index ≤30 kg/m2
. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
. If female, willing not to become pregnant up to 8 weeks after last dose of study vaccine, not breast feeding
. If female: Not pregnant, and one of the following:
. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening)

What they're measuring

Incidence of Safety and Reactogenicity Events: Adverse Events

Incidence of Safety and Reactogenicity Events: Serious Adverse Events

Timeframe: From day 0 to up to 6 months

Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions

Timeframe: From day 0 to day 3

Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions

Timeframe: From day 0 to day 3

Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry

Timeframe: Baseline, Day 14, 28, 56, 84

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria