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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2024
  • participants needed
    148
  • sponsor
    GlaxoSmithKline
Updated on 23 March 2022
vasectomy
bilateral oophorectomy
cirrhosis
vaccination
vaccine therapy
hepatitis b antigen
fibroscan
chronic hepatitis
hepatitis b e antigen
hepatitis b surface
hepatitis b core antibody

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 subjects under nucleo(s)tide treatment.

Details
Condition Hepatitis B, Chronic
Treatment Placebo, ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation, HBc-HBs/AS01B-4 high dose formulation, MVA-HBV low dose formulation, MVA-HBV high dose formulation
Clinical Study IdentifierNCT03866187
SponsorGlaxoSmithKline
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
Documented medical history of Hepatitis B Virus.e Antigen (HBeAg)-negative CHB prior to onset of NA therapy
nucleo(s)tide analogue with high barrier to resistance given as per approved
label/dosage for at least 24 months
Documented HBV viral suppression as per local clinical diagnosis within the previous 24 months AND at Screening test HBV DNA < 10 IU/mL. If no results are available, two Screening tests need to be performed at least 2 weeks apart. Small fluctuations of HBV DNA (≤ 10 x LLOQ; LLOQ defined by laboratory that performed testing) are allowed provided HBV DNA is < 10 IU/mL at Screening and was clearly not rising during the previous 24 months
FibroScan Transient Elastography (TE) score < 9.6 kPa and FibroTest score < 0.59 at Screening. A patient with one of these parameters out of range, but having the liver biopsy within 12 months before screening that showed F0-2 by METAVIR scoring system or stage 0-4 by Ishak scoring system, can be included
Documented normal level of ALT as per local clinical diagnosis within the previous 24 months AND at Screening test ALT < 48U/L. Small fluctuations of ALT (≤ 1.5 X ULN) are allowed provided ALT< 48 U/L at Screening. If no results are available, two Screening tests need to be performed at least 2 weeks apart. ULN are to be defined according to local laboratory reference range
HBsAg concentration > 50 IU/mL and anti-HBs negative at Screening
No clinical diagnosis of cirrhosis (e.g. F4 by METAVIR scoring system or ≥ 6 by Ishak scoring system or FibroScan TE score > 12.5 kPa) within the previous 24 months
Anti-HBc positive at Screening
HBeAg-negative at Screening

Exclusion Criteria

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period
Use of systemic cytotoxic agents, chronic antiviral agents or Chinese herbal medicines which, in the opinion of the investigator, may have activity against HBV within the previous 6 months prior to randomization into this study. Antiviral treatment/prevention for influenza or herpes simplex virus is allowed
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day or equivalent. Inhaled and topical steroids are allowed
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 14 days before each dose and ending 30 days after each dose of vaccines, with the exception of influenza vaccine that may be given at any time except within a 7-day period before or after each vaccine dose and COVID-19 vaccine that may be given at any time except within a 30-day period before or after each vaccine dose apart from COVID-19 mRNA based-vaccines that may be administered any time except for the period of 14 days before and 30 days after each study vaccine dose. Note: If the type of COVID-19 vaccine is unknown, the allowed interval of 30 days before or after each study vaccine dose should be followed
Treatment with nephrotoxic drugs or competitors of renal excretion within 2 months prior to Screening or the expectation that patient will receive any of these during the course of the study. TAF/TDF given as NA therapy is allowed
Administration of adenovirus/adenovector-based or MVA-based vaccine within the last 12 months except for adenovirus/adenovector-based COVID-19 vaccines that could be administered up to 30 days prior to the first study vaccine dose (applicable for all patients except for the patients in France) OR Administration of adenovirus/adenovector-based or MVA-based vaccine within the last 12 months (applicable for the patients in France only)
Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational vaccine/product
Planned for liver transplantation or previous liver transplantation
Medical history of cirrhosis or hepatic decompensation
Personal or family (first degree) history of autoimmune disease
Family history of congenital or hereditary immunodeficiency
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
Evidence of Hepatitis C Virus and hepatitis D Virus infection
Suspicion of or confirmed Hepatocellular Carcinoma or any other liver cancer in medical history or at Screening
Suspicious foci at liver imaging exam
Documented evidence of other currently active cause of hepatitis
Elevated α-fetoprotein > 50 ng/mL
Hematology and biochemistry parameters outside normal clinical range at Screening
Biochemistry
Glomerular filtration rate < 60 mL/min
Bilirubin > 27.5 µmol/L unless or the diagnosis of Gilbert Syndrome has been established and confirmed by the Investigator
GGT > 65 U/L (males) or > 45 U/L (females)
ALT > 48 U/L
AST > 42 U/L
ALP > 125 U/L
Hematology
Hemoglobin < 12.0 g/dL (females) or < 13.5 g/dL (males)
Red blood cell count < 3.9 x 10^6 cells/mm^3 (females) or < 4.4 x 10^6 cells/mm^3 (males)
White blood cell count < 3,500 cells/mm^3 or > 12,000 cells/mm^3
Platelets < 140,000 cells/mm^3
INR > 1.32 (i.e. 1.1 x ULN) unless it is considered as clinically not significant by the Investigator
Known diabetes Type I
Body Mass Index > 35 kg/m^2 at Screening
Any serious or active medical or psychiatric illnesses other than chronic hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
History of or current drug abuse and/or excess of alcohol consumption as defined per local guidelines
HIV-positive patient
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions in the period starting from the Screening Visit up to 12 weeks post-last vaccination visit
Fever and or acute minor illness may be enrolled for Screening at the discretion of the investigator, provided that the condition is resolved at the time of vaccination
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