Extra-high-dose hepatitis B vaccination does not confer longer serological protection in peritoneal dialysis patients: a randomized controlled trial.
BACKGROUND
The response to recombinant hepatitis B vaccine remains suboptimal among the dialysis population.


METHODS
In this multi-centre randomized controlled trial, we studied the factors that modify the response to intramuscular Engerix-B vaccination in patients on peritoneal dialysis. The primary aim was to study if a three-dose schedule of extra-high dose (80 microg) of Engerix-B would offer better primary seroconversion and more persistent serological protection than the conventional 40-microg dose.


RESULTS
Forty-two peritoneal dialysis patients were randomized to receive the conventional 40-microg Engerix-B dose and 45 patients to 80-microg dose. Seroconversion [hepatitis B surface antibody (anti-HBs) level > or =10 IU/l 3 months after completion of the third dose] occurred in 78.6% of patients after 40-microg Engerix-B dosage treatment versus 62.2% for those receiving 80-microg Engerix-B treatment (P = 0.11). After 12 months, the persistence of protective anti-HBs also did not differ between 40- (45.2%) and 80-microg (51.1%) treatment groups (P = 0.67). In contrast, patients with seroconversion 3 months after the third dose of Engerix-B had a higher normalized protein nitrogen appearance (nPNA) than patients without seroconversion (1.16 +/- 0.25 versus 0.96 +/- 0.23 g/kg/day, P = 0.001). Conclusions. We found no evidence of a worthwhile clinical benefit from increasing the three-dose intramuscular Engerix-B vaccine from 40- to 80-microg dose. An unplanned analysis suggested a role of improved protein intake to improve the immune response to hepatitis B vaccine in peritoneal dialysis patients.
Chow
Kai Ming
KM
Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China. Chow_Kai_Ming@alumni.cuhk.net
Lo
Stanley Hok King
SH
Szeto
Cheuk Chun
CC
Yuen
Sze Kit
SK
Wong
Kin Shing
KS
Kwan
Bonnie Ching Ha
BC
Leung
Chi Bon
CB
Li
Philip Kam-Tao
PK
D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000276:immunology / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis; D012189:Retrospective Studies; D016896:Treatment Outcome
C075654:Engerix-B; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines