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

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Nevens, Frederik Zuckerman, Jane N. Burroughs, Andrew K. Jung, Maria-Christina Bayas, Jose M. Stoffel, Michel

Patients with chronic liver disease are at higher risk of hepatitis B (HB) virus infection before and after liver transplantation, and they commonly have e. 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.

Document type Article de périodique (Journal article) – Article de recherche
Publication date 2006
Language Anglais
Journal information "Liver Transplantation" - Vol. 12, no. 10, p. 1489-1495 (2006)
Peer reviewed yes
Publisher John Wiley & Sons Inc (Hoboken)
issn 1527-6465
e-issn 1527-6473
Publication status Publié
Affiliation UCL
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Bibliographic reference Nevens, Frederik ; Zuckerman, Jane N. ; Burroughs, Andrew K. ; Jung, Maria-Christina ; Bayas, Jose M. ; et. al. Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. In: Liver Transplantation, Vol. 12, no. 10, p. 1489-1495 (2006)
Permanent URL http://hdl.handle.net/2078.1/38189