A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years

NCT05561673 | Completed Phase 1 Results

• 2 other identifiers: 2153012021-005629-25
• Study Type: interventional
• Target: 122
• Locations: 3 countries
• Sites: 5

Brief Summary

This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant.

Conditions

Hepatitis B

Keywords

Hepatitis B; Hepatitis B virus; Hepatitis B surface antigen; Aluminum hydroxide; Adjuvant System; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (23)

• Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1

  Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

  Day 1 (day of administration) to Day 14

• Number of Participants With Solicited Administration Site AEs After Dose 2

  Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

  Day 31 (day of administration) to Day 45

• Number of Participants With Solicited Systemic AEs After Dose 1

  Assessed solicited systemic events included fever (defined as temperature greater than or equal to (\>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

  Day 1 (day of administration) to Day 14

• Number of Participants With Solicited Systemic AEs After Dose 2

  Assessed solicited systemic events included fever (defined as temperature \>=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

  Day 31 (day of administration) to Day 45

• Duration in Days of Solicited Administration Site AEs After Dose 1

  Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

  Day 1 (day of administration) to Day 14

• Duration in Days of Solicited Administration Site AEs After Dose 2

  Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

  Day 31 (day of administration) to Day 45

• Duration in Days of Solicited Systemic AEs After Dose 1

  Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

  Day 1 (day of administration) to Day 14

• Duration in Days of Solicited Systemic AEs After Dose 2

  Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

  Day 31 (day of administration) to Day 45

• Number of Participants With Any Unsolicited AEs After Dose 1

  An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Day 1 (day of administration) to Day 31

• Number of Participants With Any Unsolicited AEs After Dose 2

  Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

  Day 31 (day of administration) to Day 61

• Number of Participants With Serious AEs (SAEs)

  An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.

  Throughout the entire study period (from Day 1 to Day 361)

• Number of Participants With Medically Attended AEs (MAEs)

  An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination.

  Throughout the entire study period (from Day 1 to Day 361)

• Number of Participants With AEs Leading to Study Withdrawal

  An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.

  Throughout the entire study period (from Day 1 to Day 361)

• Number of Participants With Potential Mediated Immune Diseases (pIMDs)

  pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination.

  Throughout the entire study period (from Day 1 to Day 361)

• Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1

  In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).

  At Day 8 (relative to baseline [pre-vaccination Day 1])

• Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1

  In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

  At Day 31 (compared with baseline [prevaccination, Day 1])

• Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2

  In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

  At Day 38 (compared with baseline [pre-vaccination, Day 1])

• Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2

  In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

  At Day 61 (compared with baseline [pre-vaccination, Day 1])

• Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1

  In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

  At Day 1 (baseline)

• Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8

  In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

  At Day 8

• Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31

  In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

  At Day 31

• Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38

  In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

  At Day 38

• Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61

  In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

  At Day 61

Secondary Outcomes (3)

• Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations

  At Day 1, Day 31, Day 61 and Day 361

• Percentage of Participants Who Seroconverted for Anti-HBs

  At Day 31, Day 61 and Day 361

• Percentage of Participants Seroprotected for Anti-HBs

  At Day 31, Day 61 and Day 361

Study Arms (5)

HBs-alum Group

ACTIVE COMPARATOR

Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181.

Combination Product: GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide

HBs-AS03 Group

EXPERIMENTAL

Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31.

Biological: GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system

HBs-AS04 Group

EXPERIMENTAL

Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31.

Biological: GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system

HBs-AS37B Group

EXPERIMENTAL

Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31.

Biological: GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg)

HBs-AS37A Group

EXPERIMENTAL

Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31.

Biological: GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)

Interventions

GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide COMBINATION_PRODUCT

Three doses of GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide administered intramuscularly in the non-dominant arm, one each at Day 1, Day 31 and Day 181.

Also known as: Engerix-B

HBs-alum Group

GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system BIOLOGICAL

Two doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

HBs-AS03 Group

GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system BIOLOGICAL

Two doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

Also known as: Fendrix

HBs-AS04 Group

GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) BIOLOGICAL

Two doses of GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

HBs-AS37B Group

GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) BIOLOGICAL

Two doses of GSK's HBsAg (20 μg )vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.

HBs-AS37A Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who the investigator believe can and will comply with the requirements of the protocol.
• Written informed consent obtained from the participant prior to performance of any study-specific procedure.
• Healthy participants as established by medical history, clinical examination and clinical laboratory assessment before entering the study.
• A male or female between, and including, 18 and 45 years at the time of the first study intervention administration.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• Female participants of childbearing potential may be enrolled in the study, if the participant:
• has practiced adequate contraception for 1 month prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception during the entire treatment period and for at least 3 months after completion of the study intervention administration series.
• blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range.

You may not qualify if:

• Medical conditions
• Previous vaccination against Hepatitis B.
• Positive for anti-HBs antibodies or anti-HBc antibodies or HBsAg.
• Any previous administration of monophosphoryl lipid (MPL) and/or AS37.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any confirmed or suspected autoimmune disease.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• Recurrent history or uncontrolled neurological disorders or seizures.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• Any clinically significant\* haematological and/or biochemical laboratory abnormality.
• \*The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
• Any past or current malignancies and lymphoproliferative disorders.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product (drug or vaccine) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) or their planned use during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study intervention(s) administration with the exception of influenza vaccine (pandemic or seasonal).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Cologne, 51069, Germany

Location

GSK Investigational Site

Hamburg, 22143, Germany

Location

GSK Investigational Site

Magdeburg, 39120, Germany

Location

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Aluminum Hydroxide; Engerix-B; Fendrix

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: October 4, 2022
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

DE (3); GB (1); BE (1)