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ChAdOx1-HBV

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

Ensayo de Barinthus Biotherapeutics plc. en Hepatitis B · Voluntarios sanos.

Más ensayos de: Hepatitis B.

Fase

Fase 1

Estado

Completado

Participantes

47

previstos

Centros

4

Fin del objetivo primario

may 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2019.

Qué mide

Incidence of Safety and Reactogenicity Events: Adverse Events (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)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de BRNS

Todos los de BRNS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04297917), actualizada en jul 2025.