A novel method to assess mucosal immune response in the genitourinary mucos
a after immunization with a mucosal vaccine has been developed. In this met
hod, secretory IgA antibody is measured by a highly sensitive enzyme immuno
assay (immune-complex transfer enzyme immunoassay) using urine as a specime
n. The urinary IgA antibody response could be detected by the immune-comple
x transfer enzyme immunoassay, In contrast, a conventional enzyme immunoass
ay (enzyme-linked immunosorbent assay (ELISA)) could not detect this respon
se because of its low sensitivity. Because urine samples can be collected e
asily and nontraumatically, not only from experimental animals but also fro
m humans, both males and females, the present method may be applicable for
assessing the protective efficacy of candidates for mucosal vaccines agains
t sexually transmitted microorganisms, such as human immunodeficiency virus
. Furthermore, the usefulness of this method for novel mucosal vaccine form
ulae was shown for a model in which vaccine antigen and Bordetella pertussi
s adjuvant were adsorbed onto CaCO3 and enclosed in enteric coated capsules
.