An enzymatically cleaved glycoprotein fragment (amino acids 28-328: 40
kDa) from influenza virus haemagglutinin (TOPS) was used to assess an
intravaginal antigen delivery system, comprising lysophosphatidylchol
ine (LPC) and degradable starch microspheres (DSM). Three groups of th
ree sheep received intravaginal immunization with TOPS as follows: gro
up 2, TOPS in solution; group 3, TOPS and DSM/LPC as a powder formulat
ion and group 4, TOPS and LPC in solution. A fourth group, group 1, re
ceived intramuscular immunization with TOPS adsorbed to aluminium hydr
oxide gel (Alugel). Intravaginal immunizations were repeated on two co
nsecutive days. Two weeks later, booster doses of the same formulation
s were administered on two consecutive days to each group. Group 1 she
ep were boosted with a single injection, 2 weeks after the single prim
ary immunization. The serum and vaginal wash IgA and IgG antibody resp
onses were compared among the four groups of sheep at days 15, 30 and
45 after the booster immunizations. At day 45, the serum IgG and the v
aginal wash IgA antibody responses induced by TOPS and DSM/LPC (group
3), were significantly greater than the responses induced by intravagi
nal immunization with TOPS (group 2). However, the highest levels of a
ntibodies in serum and vaginal wash samples were induced by intramuscu
lar immunization with TOPS and Alugel (group 1). Intravaginal immuniza
tion with TOPS and LPC (group 4) did not result in the induction of en
hanced levels of antibodies in serum or vaginal wash sa les.