TerminatedPhase 1/2

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

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.

Belgium236 participantsStarted 2019-03-28

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the patient prior to performing any study specific procedure. * A male or female between, and including, 18 and 65 years of age at the time of the first vaccination. * Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. * Female patients of childbearing potential may be enrolled in the study if the patient: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test at Screening, and * has agreed to continue adequate contraception from Screening until 12 weeks after completion of the vaccination series * Male patients: * with documented bilateral vasectomy and resultant azoospermia, bilateral orchiectomy or azoospermia, or * who agree to practice abstinence from penile-vaginal intercourse (when this is their preferred and usual lifestyle) or use condoms from Screening until 12 weeks after completion of the vaccination series. * Chronic Hepatitis B (CHB) patient, under and adherent to treatment with a nucleo(s)tide analogue with high barrier to resistance given as per approved label/dosage for at least 24 months. * Documented medical history of Hepatitis B Virus e Antigen (HBeAg)-negative CHB prior to onset of NA therapy (applica…

What they're measuring

Number of Participants Reporting Any Solicited Administration Site Events After Vaccination 1

Timeframe: Within 7 days after vaccination 1 occurring on Day 1

Number of Participants Reporting Any Solicited Administration Site Events After Vaccination 2

Timeframe: Within 7 days after vaccination 2 occurring on Day 57

Number of Participants Reporting Any Solicited Administration Site Events After Vaccination 3

Timeframe: Within 7 days after vaccination 3 occurring on Day 113

Number of Participants Reporting Any Solicited Administration Site Events After Vaccination 4

Timeframe: Within 7 days after vaccination 4 occurring on Day 169

Number of Participants Reporting Any Solicited Systemic Events After Vaccination 1

Timeframe: Within 7 days after vaccination 1 occurring on Day 1

Number of Participants Reporting Any Solicited Systemic Events After Vaccination 2

Timeframe: Within 7 days after vaccination 2 occurring on Day 57

Number of Participants Reporting Any Solicited Systemic Events After Vaccination 3

Timeframe: Within 7 days after vaccination 3 occurring on Day 113

Trial details

NCT IDNCT03866187

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-07

Results submitted2025-10-07

View on ClinicalTrials.gov More Hepatitis B, Chronic trials