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NCT05561673

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
GlaxoSmithKline·Phase 1/2·ClinicalTrials.gov·combination productRecruiting
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Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Cambridge, United Kingdom
Timeline & enrollment
Phase
Phase 1/2
Start date
Oct 04, 2022
End date
Aug 05, 2024
Enrollment
150 participants
Primary outcome

Percentage of participants with solicited administration site events,Percentage of participants with solicited administration site events,Percentage of participants with solicited systemic events,Percentage of participants with solicited systemic events,Duration of solicited administration site events,Duration of solicited administration site events,Duration of solicited systemic events,Duration of solicited systemic events,Percentage of participants with any unsolicited adverse events (AEs),Percentage of participants with any unsolicited adverse events (AEs),Percentage of participants with serious AEs (SAEs),Percentage of participants with medically attended AEs (MAEs),Percentage of participants with AEs leading to study withdrawal,Percentage of participants with potential mediated immune diseases (pIMDs),Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 8,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 31,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 38,Percentage of participants with changes from baseline (pre-vaccination, Day 1) in haematology and biochemistry parameters at Day 61,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 1,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 8,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 31,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 38,Percentage of participants with abnormal haematology and biochemistry laboratory parameter values at Day 61

Summary

This study is conducted to assess the 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.

ICD-10 classifications
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05561673
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05561673 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.