700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
703
intradermal vaccination
Phetchabun Province primary schools
Phetchabun, Phetchabun, Thailand
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Time frame: seven days after the first booster dose
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Time frame: one year after the first booster dose
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Time frame: immediately before administration of the first booster dose
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