Loading clinical trials...

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

COMPLETEDPHASE1

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

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

NCT05561673•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
+20 more criteria

Locations (5)

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Cologne, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Magdeburg, Germany

GSK Investigational Site

Cambridge, United Kingdom

Key Dates

Start Date

October 4, 2022

Primary Completion Date

November 29, 2024

Completion Date

November 29, 2024

Last Updated

January 15, 2026

Enrollment

122

ACTUAL participants

Conditions

Hepatitis B

Interventions

GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide

COMBINATION_PRODUCT

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

View study

RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series