Nephrology Dialysis Transplantation, Vol 12, Issue 6 1204-1211, Copyright © 1997 by Oxford University Press
Intradermal versus intramuscular hepatitis B re-vaccination in non-responsive chronic dialysis patients: A prospective randomized study with cost-effectiveness evaluation
F Fabrizi, S Andrulli, G Bacchini, M Corti and F Locatelli
Nephrology and Dialysis Unit, Hospital, Lecco, Italy; Corresponding author address: UCLA School of Medicine, Department of Medicine, 675 Circle Dr. South, MRL Room 1230, Los Angeles, CA 90095-7019, USA
Background. It has been calculated that 30% of chronic
uraemic patients fail to produce antibodies to HBsAg antigen after
hepatitis B (HB) vaccination. Low-dose intradermal (i.d.) inoculations and
supplementary intramuscular (i.m.) injections have been reported to improve
the response rate in previous non-responder chronic uraemic patients, but
no cost-effectiveness evaluations have been made about this issue.
Methods. We re-vaccinated 50 chronic dialysis
patients, who did not have any detectable anti-HBs antibody after a
reinforced protocol of hepatitis B vaccine given by i.m. route, with
hepatitis B recombinant DNA yeast vaccine (80 &mgr;g) by intradermal
(25 patients) or intramuscular (25 patients) administration (randomly
allocated). We used the same amount of HBsAg in order to exclude the
confounding effect of the dose level administered on the immune response of
uraemic patients. We studied, over a 20-month follow-up, the persistence of
anti-HBs antibodies in our responder vaccinees. We made a comparison
between the costs of our re-vaccination protocol and the other
re-vaccination strategies that have been recently suggested.
Results. One month after completion of re-vaccination
protocol, seroconversion rates (100% vs 48%,
P=0.008) and proportion of patients who elicited
protective anti-HBs titres (96% vs 40%,
P=0.0001) were significantly higher in i.d. compared
to i.m. patients. The levels of anti-HBs, expressed as geometric mean
titres and 95% confidence intervals (GMT (95% CI)), were significantly
increased in i.d. than in i.m. groups, 100 (44-187) vs
26 (14-52) mUI/ml (P=0.018). At month 12, the
seroconversion rates were 57 vs 14% in i.d. and i.m.
groups respectively (P=0.158); the seroprotection rate
was higher in i.d. individuals in comparison with i.m. patients, 50
vs 0%, P=0.072. At month 20, the
seroconversion rates were 54 and 0% among i.d. and i.m. patients
respectively (P=0.055); the seroprotection rate was
higher in i.d. than in i.m. group (30 vs 0%,
P=0.2). At month 20, the median anti-HBs titres in
i.d. patients were 21 mUI/ml, and GMT (95% CI) were 20.9 (2-54) mUI/ml. No
important general or local side-effects were observed. The cost of our
schedule was $92 US whereas the costs of other re-vaccination protocols
ranged between 138 and $807 US. Conclusions. Our
results show that the unresponsiveness to recombinant yeast-derived vaccine
may be mostly reversed by repeated low-dose i.d. injections of the same
agent. In spite of an equal amount of HBsAg received, i.d. hepatitis B
re-vaccination shows higher immunogenicity compared to i.m. administration
over a 20-month observation period. Cost-effectiveness analysis
demonstrated that the intradermal administration of HB vaccine is the most
clinically effective re-vaccination strategy; it is also the most
unexpensive one. We strongly recommend low-dose intradermal inoculations in
order to re-vaccinate chronic dialysis patients who fail to respond to
hepatitis B vaccination. Keywords: intradermal
re-vaccination; chronic dialysis patients; non-responsiveness to HB
vaccine; cost analysis
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