Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients

✍ Scribed by Frederik Nevens; Jane N. Zuckerman; Andrew K. Burroughs; Maria-Christina Jung; José M. Bayas; Birgit Kallinowski; Enrique Fraga Rivas; Christophe Duvoux; Peter Neuhaus; Faouzi Saliba; Maria Buti; Jean-Pierre Zarski; Fernando Pons; Claire Vanlemmens; Virginie Hamtiaux; Michel Stoffel

• Publisher: John Wiley and Sons
• Year: 2006
• Tongue: English
• Weight: 166 KB
• Volume: 12
• Category: Article
• ISSN: 1527-6465
• DOI: 10.1002/lt.20836

✦ Synopsis

Patients with chronic liver disease are at higher risk of hepatitis B (HB) virus infection before and after liver transplantation, and they commonly have a suboptimal immune response to HB vaccines. In this randomized trial, we compared the immunogenicity of primary vaccination with 2 doses of an experimental adjuvanted HB vaccine (adjuvant system 04 containing aluminium and monophosphoryl lipid A [HB-AS04]) to that of 3 double doses of a licensed HB vaccine in 93 liver transplant candidates. Depending on the waiting list for liver transplantation, a booster dose of HB-AS04 or double booster dose of the licensed HB vaccine was given before or after surgery, at 6 to 12 months after initiation of the vaccination course. The percentage of subjects with seroprotective anti-HB surface antibody concentrations 1 month after booster was twice as high in the HB-AS04 group (60.0%), vs. patients in the comparator group (32.0%) (P = 0.035). In subjects who did not undergo liver transplantation before administration of the booster, better immunogenicity results were obtained: 80% of subjects were seroprotected after HB-AS04 vaccination vs. 60% with the comparator (P = 0.2302). Despite a slightly higher reactogenicity, the safety profile of the HB-AS04 vaccine was clinically acceptable. In conclusion, an improved antibody response was observed in liver transplant candidates with 3 doses of HB-AS04, as compared to 4 double doses of a comparator. Liver transplant candidates could benefit from the use of this experimental adjuvanted HB vaccine to further increase their protection against HB infection.