* EARLY-CLINRES-017
Research type
Research Study
Full title
A Phase 1/2a, open-label, randomised, controlled, multi-country, doseescalation 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
IRAS ID
1005899
Contact name
François Roman
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Eudract number
2021-005629-25
Clinicaltrials.gov Identifier
Research summary
A vaccine usually contains an agent called an antigen. An antigen looks like the microbe causing the disease but cannot make you sick. However, it is still able to teach the body how to protect itself. Some substances, called adjuvants, can improve the strength and
the duration of protection of a vaccine. GSK has developed a portfolio of adjuvant combinations, called Adjuvant Systems (AS). Adjuvant Systems (AS03, AS04 and AS37), which will be tested in this study, have already been given to healthy young adults in previous clinical trials, either in combination with Hepatitis B surface antigen (HBsAg), the antigen used in this study, or with other antigens. In all these studies, no
safety concerns have been identified that would preclude the use of these adjuvants in people.This is the first time that Adjuvant System 37 (AS37) together with HBsAg is being tested in people. This study is done to test if AS37 together with HBsAg is well-tolerated and if it can generate an immune response, in comparison to HBsAg combined with other
Adjuvant Systems or aluminium hydroxide (alum). This will be done in healthy adults who are 18-45 years of age, and neither been vaccinated nor infected with Hepatitis B.Approximately 150 people will take part in this study which will last for 361 days.
REC name
London - Brent Research Ethics Committee
REC reference
22/FT/0099
Date of REC Opinion
19 Aug 2022
REC opinion
Further Information Favourable Opinion