Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

Summary

A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.

Timeline

Start

2019-03-28

Primary completion

2024-10-07

Completion

2024-10-07

Outcome

Outcome not reported

Stopped: “Following the primary phase (24 weeks post last vaccination) the predefined efficacy endpoint was not met. Noting the lack of efficacy and with the objective to prioritize participants' safety GSK has decided on the early termination of the study.”

Drugs

Indications