Hepatitis BPhase 1NCT05561673
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
A Phase 1 study testing GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system and GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system in people with Hepatitis B, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system and GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 4 Oct 2022to 29 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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).
- A vaccine not foreseen by the study protocol administered during the period starting at Visit 1 or 30 days before each dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of influenza vaccine (pandemic or seasonal).
- In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by public health authorities outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine, provided it is licensed/authorised and used according to its Product Information.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.
- Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational intervention.
- Other exclusions
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any study personnel or their immediate depandants, family, or household members.
- Specific exclusion for MRI-assessable subgroup participants (post-randomization procedure)
- Presence of pacemakers, metal implants and/or prostheses.
- Claustrophobia.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
GSK Investigational Site
Cologne, 51069
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Magdeburg, 39120
About this study
Official title: A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination With the Hepatitis B Surface Antigen (HBsAg), According to a 0-1 Month Schedule, in Healthy, HBs naïve, Adults Aged 18-45 Years
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
- Being tested
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system, GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg), GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)
- Keywords
- Hepatitis B, Hepatitis B virus, Hepatitis B surface antigen, Aluminum hydroxide, Adjuvant System, Safety, Immunogenicity
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxideCombination product
Also called Engerix-B
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.
GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant systemBiological
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.
GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant systemBiological
Also called Fendrix
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 61
Secondary outcomes (3)
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations
Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL).
Measured: At Day 1, Day 31, Day 61 and Day 361
Percentage of Participants Who Seroconverted for Anti-HBs
A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (>) 6.2 mIU/mL.
Measured: At Day 31, Day 61 and Day 361
Percentage of Participants Seroprotected for Anti-HBs
A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration >10 mIU/mL.
Measured: At Day 31, Day 61 and Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start4 Oct 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561673
- Sponsor's protocol ID
- 215301
- Other IDs
- 2021-005629-25
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2022
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess the Safety and Immunogenicity of AS37 in Combination With the Hepatitis B Surface Antigen (HBsAg), According to a 0-1 Month Schedule, in Healthy, HBs naïve, Adults Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT05561673
- Acronym / sponsor ID
- 215301
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Hepatitis B virus, Hepatitis B surface antigen, Aluminum hydroxide, Adjuvant System, Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HBs-alum Group | Active comparator | Combination Product: GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxideParticipants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181. |
| HBs-AS03 Group | Experimental | Biological: GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant systemParticipants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31. |
| HBs-AS04 Group | Experimental | Biological: GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant systemParticipants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31. |
| HBs-AS37B Group | Experimental | Biological: GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg)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. |
| HBs-AS37A Group | Experimental | Biological: GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxideAlso: Engerix-BThree 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. | Combination product | HBs-alum Group |
| GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant systemTwo 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. | Biological | HBs-AS03 Group |
| GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant systemAlso: FendrixTwo 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. | Biological | HBs-AS04 Group |
| GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg)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. | Biological | HBs-AS37B Group |
| GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)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. | Biological | HBs-AS37A Group |
Primary outcome
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1
Time frame: Day 1 (day of administration) to Day 14
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.
Number of Participants With Solicited Administration Site AEs After Dose 2
Time frame: Day 31 (day of administration) to Day 45
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.
Number of Participants With Solicited Systemic AEs After Dose 1
Time frame: Day 1 (day of administration) to Day 14
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.
Number of Participants With Solicited Systemic AEs After Dose 2
Time frame: Day 31 (day of administration) to Day 45
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.
Duration in Days of Solicited Administration Site AEs After Dose 1
Time frame: Day 1 (day of administration) to Day 14
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration in Days of Solicited Administration Site AEs After Dose 2
Time frame: Day 31 (day of administration) to Day 45
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration in Days of Solicited Systemic AEs After Dose 1
Time frame: Day 1 (day of administration) to Day 14
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration in Days of Solicited Systemic AEs After Dose 2
Time frame: Day 31 (day of administration) to Day 45
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Number of Participants With Any Unsolicited AEs After Dose 1
Time frame: Day 1 (day of administration) to Day 31
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.
Number of Participants With Any Unsolicited AEs After Dose 2
Time frame: Day 31 (day of administration) to Day 61
Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Number of Participants With Serious AEs (SAEs)
Time frame: Throughout the entire study period (from Day 1 to Day 361)
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.
Number of Participants With Medically Attended AEs (MAEs)
Time frame: Throughout the entire study period (from Day 1 to Day 361)
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.
Number of Participants With AEs Leading to Study Withdrawal
Time frame: Throughout the entire study period (from Day 1 to Day 361)
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.
Number of Participants With Potential Mediated Immune Diseases (pIMDs)
Time frame: Throughout the entire study period (from Day 1 to Day 361)
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.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1
Time frame: At Day 8 (relative to baseline [pre-vaccination Day 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).
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1
Time frame: At Day 31 (compared with baseline [prevaccination, 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.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2
Time frame: At Day 38 (compared with baseline [pre-vaccination, 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.
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2
Time frame: At Day 61 (compared with baseline [pre-vaccination, 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.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1
Time frame: At Day 1 (baseline)
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.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8
Time frame: 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.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31
Time frame: 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.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38
Time frame: 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.
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61
Time frame: 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.
3 secondary outcomes
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations
Time frame: At Day 1, Day 31, Day 61 and Day 361
Percentage of Participants Who Seroconverted for Anti-HBs
Time frame: At Day 31, Day 61 and Day 361
Percentage of Participants Seroprotected for Anti-HBs
Time frame: At Day 31, Day 61 and Day 361
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system and GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system in people with Hepatitis B, run by GlaxoSmithKline at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 (time frame: Day 1 (day of administration) to Day 14). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.