Comparison of intradermal and intramuscular administration of hepatitis B vaccine in neonates.
BACKGROUND
Hepatitis B virus (HBV) infection and its complications are among the most common diseases in Iran. National mass vaccination of neonates against hepatitis B was started in 1991, but was considered a costly venture.


OBJECTIVE
To compare the efficacy of low-dose intradermal HBV recombinant vaccine with standard intramuscular dose in neonates.


METHODS
165 apparently healthy neonates born in Shiraz were randomized to receive either 10 microg [corrected] of recombinant vaccine intramuscularly (IM; n=82) or 2 microg [corrected] vaccine intradermally (ID; n=83) at months 0, 1, 6. Anti-HBs titers were measured at 6 and 18 months after the first dose.


RESULTS
53 and 51 neonates in the IM and ID groups, respectively, completed the study. Protective anti-HBs titers (>10 IU/L) at 18 months after the first dose were achieved in 98.1% and 96.2% of neonates in IM and ID groups, respectively (p=ns). The only side effect in the ID group was local hyperpigmentation, which was seen in 55%; no significant side effect was reported in the IM group.


CONCLUSIONS
Intradermal vaccination with 20% of standard dose is as effective as IM vaccination when evaluated at 18 months after the first dose.
Lankarani
K B
KB
Department of Internal Medicine, Shiraz University of Medical Sciences, Islamic Republic of Iran. Lankaran@sums.ac.ir
Taghavi
A R
AR
Agah
S
S
Karimi
A
A
D016009:Chi-Square Distribution; D005260:Female; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D007492:Iran; D008297:Male
D017325:Hepatitis B Vaccines