Introduction: Type A hepatitis virus (HAV) is a serious health problem thro
ughout the world and can be spread via fecal-oral contact. Both immune glob
ulin and an HAV vaccine provide protection, but the vaccine gives complete
protection. Efficacy of methods of vaccination in relation to the formation
of anti-HAV antibodies is unclear; thus, this study seeks to determine if
significant differences exist between the syringe as compared to the jet in
jection technique.
The purpose of this study was to compare in a randomized trial Biojet jet-i
njection system to a needle-syringe method. To determine if a significant d
ifference between these two methods in seroconversion rates or geometric me
an titers of anti HAV antibody occurs at day 15, 30, and 210 days after vac
cination.
Method: Anti-HAV IgG(-) adult hospital employees were randomized to receive
1440 EL.U of hepatitis a vaccine (HAVRIX(R)) in 2 doses by either needle o
r jet-injector (Biojector(R)) system at month 0 and 6. HAV seroconversion t
iter results were measured by the Boehringer-Mannheim method.
Results/discussion: A higher proportion of persons who received HAV vaccine
via the Biojector(R) seroconverted with anti-HAV level greater than or equ
al to 20 mIU at day 15, 30, and month 7 when compared with a needle injecti
on.
Side-effect profiles reported by participants in both methods were below th
ose identified in current published and insert information, but the Bioject
or(R) had greater local reactivity in all categories when compared to the n
eedle method. (C) 2000 Elsevier Science Ltd. All rights reserved.