The booster responses of three different formulations of intranasal (i
.n.) diphtheria-tetanus (D-T) vaccines were determined in military rec
ruits and compared with a conventional subcutaneous D-T vaccine. The v
accines for mucosal delivery were sprayed into one nostril and contain
ed D and T toxoids in an enhancer mixture of polysorbate and caprylic/
capric glycerides. All of the vaccines gave rise mainly to a systemic
IgG response. Among 51 persons with anti-D antibody concentrations in
serum below a protective level of 0.01 international units (IU mi befo
re vaccination, all except two attained protective antibody concentrat
ions 4 weeks after vaccination The median increase in anti-D antibody
concentration Mins 113-fold with the most efficient in. formulation. T
he median increase in anti-T antibody level was 2.4-fold, however, the
pre-vaccination levels for this antigen were very high. Within the ex
amined levels, the booster response depended mainly on the dose of the
antigen in the vaccine rather than on the concentration of the vehicl
e mixture. Compared with the parenteral D-T vaccine containing alumini
um hydro,vide as an adjuvant, all of the rested in. formulations showe
d somewhat lower immunogenicity in man as well as in pre-clinical guin
ea-pig studies. Among 215 persons immunized i.n., 61% preferred this r
oute of administration rather than a parenteral injection, although th
e formulations were all associated with varying local symptoms,frequen
tly stinging and pronounced, nasal secretion. (C) 1997 Elsevier Scienc
e Ltd.