First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB In… (NCT04297917) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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)
✓. Receipt of only either entecavir or tenofovir for at least 12 months before screening
Exclusion criteria
✕. Presence of any significant acute or chronic, uncontrolled medical/ psychiatric illness
What they're measuring
1
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)
2
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
Timeframe: From day 0 to up to 6 months
3
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Timeframe: From day 0 to day 3
4
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Timeframe: From day 0 to day 3
5
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
✕. History or evidence of autoimmune disease or known immunodeficiency of any cause
✕. Prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics (e.g. monoclonal antibodies, interferon) within 3 months of screening
✕. Receipt of immunoglobulin or other blood products within 3 months prior to screening
✕. Receipt of any investigational drug or vaccine within 3 months prior to screening
✕. Cohorts 1-4: Receipt of any adenoviral vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0