Nevens, F and Zuckerman, JN and Burroughs, AK and Jung, MC and Bayas, JM and Kallinowski, B and Rivas, EF and Duvoux, C and Neuhaus, P and Saliba, F and Buti, M and Zarski, JP and Pons, F and Vanlemmens, C and Hamtiaux, V and Stoffel, M (2006) Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. LIVER TRANSPLANT , 12 (10) 1489 - 1495. 10.1002/lt.20836.
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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.
|Title:||Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients|
|Keywords:||HEMODIALYSIS-PATIENTS, DISEASE, RECIPIENTS, IMMUNIZATION, TRANSMISSION, INFECTION, CIRRHOSIS, ANTIBODY, FAILURE, DONORS|
|UCL classification:||UCL > School of Life and Medical Sciences > Faculty of Medical Sciences > Infection and Immunity (Division of) > Research Department of Infection|
UCL > School of Life and Medical Sciences > Faculty of Medical Sciences > Medicine (Division of)
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