A prophylactic hepatitis B vaccine with a novel adjuvant system.
Studies with recombinant hepatitis B vaccines show seroprotection rates varying between 91 and 100%. Thus, a limited risk may remain for non-responding populations (e.g. non-responders, haemodialysis patients, elderly) who could benefit from a more immunogenic hepatitis B vaccine. One strategy to enhance the immune response is the use of novel adjuvants. SmithKline Beecham has developed a new adjuvant system containing alum and 3-deacylated monophosphoryl lipid A: SBAS4 (SmithKline Beecham Adjuvant System 4). Pilot studies showed that SBAS4 improved in vivo humoral and in vitro cellular immune responses compared to the response to classical recombinant hepatitis B vaccines and was safe and well-tolerated. Several studies assessed the profile of the HBsAg/SBAS4 vaccine in a healthy population, non-responders or elderly. In general the HBsAg/SBAS4 vaccine was well tolerated. Compared to an established recombinant hepatitis B vaccine, we observed an increased local reactogenicity but few symptoms were reported as severe. The HBsAg/SBAS4 vaccine elicits a strong immune response: subjects are protected faster and the GMTs are usually much higher. HBsAg/SBAS4 thus has the potential to protect those subjects who fail to be protected by well established hepatitis B vaccines.
Thoelen
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SmithKline Beecham Biologicals, Rue de l'Institut 89, 1330, Rixensart, Belgium.
De Clercq
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Tornieporth
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D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000534:Alum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000008:administration & dosage / Q000009:adverse effects; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007111:Immunity, Cellular; D008050:Lipid A / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D012449:Safety; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects
D000276:Adjuvants, Immunologic; D000534:Alum Compounds; C075654:Engerix-B; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D008050:Lipid A; C410283:SBAS4 adjuvant system; D014614:Vaccines, Synthetic