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

NCT03866187 | Terminated Phase 1 Results

• 2 other identifiers: 2048522017-001452-55
• Study Type: interventional
• Target: 236
• Locations: 9 countries
• Sites: 43

Brief 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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (21)

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

  Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The below presented data is read as follows: * For Step C: Group C1, Vaccine A = ChAd155-hIi-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation. * For Step C: Group C2, Vaccine A = Placebo / Vaccine B = Placebo.

  Within 7 days after vaccination 1 occurring on Day 1

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

  Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The below presented data is read as follows: * For Step C: Group C1, Vaccine A = MVA-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation. * For Step C: Group C2, Vaccine A = Placebo / Vaccine B = Placebo.

  Within 7 days after vaccination 2 occurring on Day 57

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

  Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The below presented data is read as follows: * For step C: Group C1, Vaccine A = MVA-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation. * For step C: Group C2, Vaccine A = ChAd155-hIi-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation.

  Within 7 days after vaccination 3 occurring on Day 113

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

  Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. The below presented data is read as follows: * For Step C: Group C1, Vaccine A = MVA-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation. * For Step C: Group C2, Vaccine A = MVA-HBV high dose formulation / Vaccine B = HBc-HBs-AS01B high dose formulation.

  Within 7 days after vaccination 4 occurring on Day 169

• Number of Participants Reporting Any Solicited Systemic Events After Vaccination 1

  Assessed solicited systemic events included chills, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and fever. Fever is defined as oral temperature greater than or equal to (\>=) 38.0°C/100.4°F. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 7 days after vaccination 1 occurring on Day 1

• Number of Participants Reporting Any Solicited Systemic Events After Vaccination 2

  Assessed solicited systemic events included chills, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and fever. Fever is defined as oral temperature \>=38.0°C/100.4°F. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 7 days after vaccination 2 occurring on Day 57

• Number of Participants Reporting Any Solicited Systemic Events After Vaccination 3

  Assessed solicited systemic events included chills, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and fever. Fever is defined as oral temperature \>=38.0°C/ 100.4°F. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 7 days after vaccination 3 occurring on Day 113

• Number of Participants Reporting Any Solicited Systemic Events After Vaccination 4

  Assessed solicited systemic events included chills, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and fever. Fever is defined as oral temperature \>=38.0°C/100.4°F. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 7 days after vaccination 4 occurring on Day 169

• Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After Vaccination 1

  An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 30 days after vaccination 1 occurring on Day 1

• Number of Participants Reporting Any Unsolicited AEs After Vaccination 2

  An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 30 days after vaccination 2 occurring on Day 57

• Number of Participants Reporting Any Unsolicited AEs After Vaccination 3

  An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 30 days after vaccination 3 occurring on Day 113

• Number of Participants Reporting Any Unsolicited AEs After Vaccination 4

  An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Within 30 days after vaccination 4 occurring on Day 169

• Number of Participants With Hematological, Biochemical and Urinalysis Laboratory Abnormalities After Vaccination 1

  The assessed parameters were: * hematological: haemoglobin decrease, white blood cells (WBCs) increase, WBCs decrease, lymphocytes decrease, neutrophils decrease, eosinophils increase, platelets decrease, prothrombin international normalized ratio (INR) increase; * biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), creatinine; * urinalysis: protein, glucose, red blood cells (RBCs). The grading of the parameters was derived from the standard FDA toxicity grading scale. The results are defined as follows: \<parameter\>,\<grade at baseline \[pre-vaccination (Day 1)\]\>,\<grade post-baseline\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening.

  Within 30 days after vaccination 1 occurring on Day 1

• Number of Participants With Hematological, Biochemical and Urinalysis Laboratory Abnormalities After Vaccination 2

  The assessed parameters were: * hematological: haemoglobin decrease, WBCs increase, WBCs decrease, lymphocytes decrease, neutrophils decrease, eosinophils increase, platelets decrease, prothrombin INR increase; * biochemical: ALT, AST, ALP, total bilirubin, GGT, creatinine; * urinalysis: protein, glucose, RBCs. The grading of the parameters was derived from the standard FDA toxicity grading scale. The results are defined as follows: \<parameter\>,\<grade at baseline \[pre-vaccination (Day 1)\]\>,\<grade post-baseline\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Not done = parameter value missing for the specified parameter.

  Within 30 days after vaccination 2 occurring on Day 57

• Number of Participants With Hematological, Biochemical and Urinalysis Laboratory Abnormalities After Vaccination 3

  The assessed parameters were: * hematological: haemoglobin decrease, WBCs increase, WBCs decrease, lymphocytes decrease, neutrophils decrease, eosinophils increase, platelets decrease, prothrombin INR increase; * biochemical: ALT, AST, ALP, total bilirubin, GGT, creatinine; * urinalysis: protein, glucose, RBCs. The grading of the parameters was derived from the standard FDA toxicity grading scale. The results are defined as follows: \<parameter\>,\<grade at baseline \[pre-vaccination (Day 1)\]\>,\<grade post-baseline\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening.

  Within 30 days after vaccination 3 occurring on Day 113

• Number of Participants With Hematological, Biochemical and Urinalysis Laboratory Abnormalities After Vaccination 4

  The assessed parameters were: * hematological: haemoglobin decrease, WBCs increase, WBCs decrease, lymphocytes decrease, neutrophils decrease, eosinophils increase, platelets decrease, prothrombin INR increase; * biochemical: ALT, AST, ALP, total bilirubin, GGT, creatinine; * urinalysis: protein, glucose, RBCs. The grading of the parameters was derived from the standard FDA toxicity grading scale. The results are defined as follows: \<parameter\>,\<grade at baseline \[pre-vaccination (Day 1)\]\>,\<grade post-baseline\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening.

  Within 30 days after vaccination 4 occurring on Day 169

• Number of Participants Reporting Serious Adverse Events (SAEs)

  An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or in other situations that were considered serious per medical or scientific judgment.

  From Day 1 until Day 337

• Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs)

  pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  From Day 1 until Day 337

• Number of Participants Reporting Liver Disease-related (LDR) Adverse Events of Special Interest (AESIs)

  LDR AESIs are defined as adverse events related to the underlying chronic HBV infection and characterized by one or more of the following: * ALT flares: Elevation of ALT \> 3 X Upper Limit of Normal (ULN): Mild: \> 3-5 X ULN, Moderate: \> 5-10 X ULN, Severe: \> 10 X ULN. * ALT flares with other substantial biochemical changes: Bilirubin \>= 2 X ULN, And/or INR \>1.5. * Hepatic decompensation: occurrence of one or more of the following events: ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy. * HBV-Deoxyribonucleic Acid (DNA) breakthrough: any increase in serum HBV DNA by \>1 log10 from nadir or redetection of serum HBV DNA at levels 10-fold the Lower Limit of Quantification (LLOQ) of the viral load after HBV DNA was undetectable.

  From Day 1 until Day 337

• Number of Participants Reporting Hematological AESIs

  Hematological AESIs are defined as: * spontaneous local or general bleeding with thrombocytes \<50,000 platelets/cubic millimeter (mm\^3), * anemia with hemoglobin (Hgb) \<9.5 gram/deciliter (g/dL).

  From Day 1 until Day 337

• Number of Participants Reporting Medically-attended Adverse Events (MAEs)

  MAEs are defined as events for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

  From Day 1 until Day 337

Secondary Outcomes (29)

• Number of Seropositive Participants for Anti-hepatitis B Core Antibody (Anti-HBc)

  At Days 1, 15, 71, 113, 127, 183, 337, 505 and 841

• Anti-HBc Antibody Concentrations

  At Days 1, 15, 71, 113, 127, 183, 337, 505 and 841

• Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Seroconversion

  At Days 1,15, 71, 113, 127, 183, 337, 505 and 841

• Anti-HBs Antibody Concentrations

  At Days 1, 15, 71, 113, 127, 183, 337, 505 and 841

• Number of Participants With Anti-HBs Antibody Concentration >=10 mIU/mL

  At Days 1,15, 71, 113, 127, 183, 337, 505 and 841

Study Arms (8)

Step A: Group A1

EXPERIMENTAL

Participants were scheduled to receive one dose of Chimpanzee adenovirus HBV vaccine (ChAd155-hIi-HBV) low dose formulation on Day 1, one dose of Modified Vaccinia Ankara HBV vaccine (MVA-HBV) low dose formulation on Day 57, and two doses of HBc-HBs/AS01B-4 low dose formulation, one on Day 113 and one on Day 169.

Biological: ChAd155-hIi-HBV low dose formulation; Biological: HBc-HBs/AS01B-4 low dose formulation; Biological: MVA-HBV low dose formulation

Step A: Group A2

ACTIVE COMPARATOR

Participants were scheduled to receive four doses of HBc-HBs/AS01B-4 low dose formulation, one dose each on Day 1, Day 57, Day 113 and Day 169.

Biological: HBc-HBs/AS01B-4 low dose formulation

Step A: Group A3

PLACEBO COMPARATOR

Participants were scheduled to receive four doses of placebo, one dose each on Day 1, Day 57, Day 113 and Day 169.

Drug: Placebo

Step B: Group B1

EXPERIMENTAL

Participants were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation on Day 1, one dose of MVA-HBV high dose formulation on Day 57, and two doses of HBc-HBs/AS01B-4 high dose formulation, one on Day 113 and one on Day 169.

Biological: ChAd155-hIi-HBV high dose formulation; Biological: HBc-HBs/AS01B-4 high dose formulation; Biological: MVA-HBV high dose formulation

Step B: Group B2

ACTIVE COMPARATOR

Participants were scheduled to receive four doses of HBc-HBs/AS01B-4 high dose formulation, one dose each on Day 1, Day 57, Day 113 and Day 169.

Biological: HBc-HBs/AS01B-4 high dose formulation

Step B: Group B3

ACTIVE COMPARATOR

Participants were scheduled to receive two doses of placebo, one on Day 1 and one on Day 57, one dose of ChAd155-hIi-HBV high dose formulation on Day 113 and one dose of MVA-HBV high dose formulation on Day 169.

Biological: ChAd155-hIi-HBV high dose formulation; Biological: MVA-HBV high dose formulation; Drug: Placebo

Step C: Group C1

EXPERIMENTAL

Participants were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation co-administered with one dose of HBc-HBs/AS01B-4 high dose formulation on Day 1, and 3 doses of MVA-HBV high dose formulation co-administered with HBc-HBs/AS01B-4 high dose formulation on Day 57, Day 113 and Day 169.

Biological: ChAd155-hIi-HBV high dose formulation; Biological: HBc-HBs/AS01B-4 high dose formulation; Biological: MVA-HBV high dose formulation

Step C: Group C2

ACTIVE COMPARATOR

Participants were scheduled to receive two co-administered doses of placebo on Day 1, two co-administered doses of placebo on Day 57, one dose of ChAd155-hIi-HBV high dose formulation co-administered with HBc-HBs/AS01B-4 high dose formulation on Day 113 and one dose of MVA-HBV high dose formulation co-administered with HBc-HBs/AS01B-4 high dose formulation on Day 169.

Biological: ChAd155-hIi-HBV high dose formulation; Biological: HBc-HBs/AS01B-4 high dose formulation; Biological: MVA-HBV high dose formulation; Drug: Placebo

Interventions

ChAd155-hIi-HBV high dose formulation BIOLOGICAL

Participants in groups B1 and B3 were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation on Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the non-dominant arm. Participants in groups C1 and C2 were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation on Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the dominant arm.

Step B: Group B1; Step B: Group B3; Step C: Group C1; Step C: Group C2

HBc-HBs/AS01B-4 low dose formulation BIOLOGICAL

Participants in group A1 were scheduled to receive two doses of HBc-HBs/AS01B-4 low dose formulation, one on Day 113 and one on Day 169, and participants in group A2 were scheduled to receive four doses of the HBc-HBs/AS01B-4 low dose formulation, one dose each on Days 1, 57, 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.

Step A: Group A1; Step A: Group A2

HBc-HBs/AS01B-4 high dose formulation BIOLOGICAL

Participants in group B1 were scheduled to receive two doses of HBc-HBs/AS01B-4 high dose formulation, one on Day 113 and one on Day 169; participants in group B2 were scheduled to receive four doses of HBc-HBs/AS01B-4 high dose formulation, one dose each on Days 1, 57, 113 and 169; participants in group C1 were scheduled to receive four co-administered doses of HBc-HBs/AS01B-4 high dose formulation on Days 1, 57, 113 and 169 and participants in group C2 were scheduled to receive two co-administered doses HBc-HBs/AS01B-4 high dose formulation on Days 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.

Step B: Group B1; Step B: Group B2; Step C: Group C1; Step C: Group C2

MVA-HBV low dose formulation BIOLOGICAL

Participants in group A1 were scheduled to receive one dose of MVA-HBV low dose formulation on Day 57, by intramuscular injection in the deltoid of the non-dominant arm.

Step A: Group A1

MVA-HBV high dose formulation BIOLOGICAL

Participants in groups B1 and B3 were scheduled to receive one dose of MVA-HBV high dose formulation on Day 57 and Day 169 respectively, by intramuscular injection in the deltoid of the non-dominant arm. Participants in group C1 were scheduled to receive three co-administered doses of the MVA-HBV high dose formulation on Days 57, 113 and 169 and participants in group C2 were scheduled to receive one co-administered dose of the MVA-HBV high dose formulation on Day 169, by intramuscular injection in the deltoid of the dominant arm.

Step B: Group B1; Step B: Group B3; Step C: Group C1; Step C: Group C2

ChAd155-hIi-HBV low dose formulation BIOLOGICAL

Participants in group A1 were scheduled to receive one dose of ChAd155-hIi-HBV low dose formulation on Day 1, by intramuscular injection in the deltoid of the non-dominant arm.

Step A: Group A1

Placebo DRUG

Participants in group A3 were scheduled to receive four doses of placebo, one each on Days 1, 57, 113 and 169 and participants in group B3 were scheduled to receive two doses of placebo one each on Days 1 and 57, by intramuscular injection in the deltoid of the non-dominant arm. Participants in group C2 were scheduled to receive two co-administered doses of placebo on Day 1 and two co-administered doses of placebo on Day 57, by intramuscular injection in the deltoid of the dominant and non-dominant arm.

Step A: Group A3; Step B: Group B3; Step C: Group C2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (applicable to all patients in Step A and Step B and to some patients in Step C) or documented medical history of HBeAg-negative CHB over a period of at least 24 months prior screening (applicable to some patients in Step C only).
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• Medical history of cirrhosis or hepatic decompensation.
• Planned for liver transplantation or previous liver transplantation.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (43)

GSK Investigational Site

Antwerp, 2650, Belgium

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Clichy, 92118, France

Location

GSK Investigational Site

Créteil, 94010, France

Location

GSK Investigational Site

Lyon, 69317, France

Location

GSK Investigational Site

Strasbourg, 67091, France

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Bonn, 53127, Germany

Location

GSK Investigational Site

Essen, 45122, Germany

Location

GSK Investigational Site

Frankfurt, 60590, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Mainz, 55131, Germany

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Krakow, 31-202, Poland

Location

GSK Investigational Site

Mysłowice, 41-400, Poland

Location

GSK Investigational Site

Poznan, 60-185, Poland

Location

GSK Investigational Site

Łańcut, 37-100, Poland

Location

GSK Investigational Site

Barcelona, 08011, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Granada, 18016, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07120, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

TorrejOn Ardoz Madrid, 28850, Spain

Location

GSK Investigational Site

Taichung, 40447, Taiwan

Location

GSK Investigational Site

Taichung, 40705, Taiwan

Location

GSK Investigational Site

Tainan, 704, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

London, E1 1BB, United Kingdom

Location

GSK Investigational Site

London, SW17 0QT, United Kingdom

Location

GSK Investigational Site

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study was conducted following a staggered design overseen by Internal Safety Review Committee (iSCR): * Step A (low dose of each vaccine): 13 participants were randomized (1:1:1). Fourteen days after the 2nd vaccination, iSRC reviewed all available safety data (of at least 12 participants if approved by local authorities). If considered appropriate to continue, Step B would start. * Step B (prime-boost with ChAd155-hIi-HBV and Modified Vaccinia Ankara HBV vaccine (MVA-HBV) and sequential administration with HBc-HBs/AS01B-4): 40 participants were first randomized (2:1:1) for vaccination. Fourteen days after the 2nd vaccination, iSRC reviewed all available safety data. If considered appropriate to continue, 36 additional participants would be randomized for vaccination. * Step C (prime-boost with ChAd155-hIi-HBV and MVA-HBV and co-administration with HBc-HBs/AS01B-4): Step C randomization (2:1) would start post completion of Step B enrolment.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: March 28, 2019
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

HK (1); TH (2); DE (6); ES (12); FR (4); PL (4); BE (6); TW (5); GB (3)