Seven healthy adult volunteers each ingested an enteric-coated capsule containing 500 micrograms of Streptococcus mutans glucosyltransferase (GTF) in dehydrated liposomes for 3 consecutive days. The immunization regimen was repeated 28 days later. Parotid saliva and plasma were collected prior to and at a weekly interval for 8 weeks following the first immunization for analysis of anti-GTF activity by enzyme-linked immunosorbent assay. The levels of immunoglobulin A1 (IgA1) and IgA2 anti-GTF activities increased in the parotid saliva from 5 of 7 individuals after immunization. Increases in the mean level of IgA1 and IgA2 anti-GTF responses peaked on day 35 (77% and 175% increase over baseline, respectively), although variation was noted in the kinetics and subclass of responses between individuals. No salivary IgG or IgM responses were observed. Low plasma IgM, IgG and IgA anti-GTF responses were seen in immunized subjects. Oral immunization with a dehydrated liposome-protein vaccine was effective in inducing a secretory IgA antibody response, which was primarily of the IgA2 subclass. These results provide the first evidence for the use an oral dehydrated liposome-protein vaccine in humans.

Here we report the effectiveness of various liposome vaccines containing Streptococcus mutans glucosyltransferase (GTF) in protecting against dental caries after oral immunization. Rats were immunized by gastric intubation of the appropriate liposome vaccine at weaning and boosted 3 times. Rats were infected with S. mutans following initial immunization and fed cariogenic diet (Diet 305). Saliva and serum were collected during the study and assessed for antibody activity by enzyme-linked immunosorbent assay. Mandibles were removed on day 47 and assessed for S. mutans levels and then for caries. Animals immunized with sonicated, filtered and microemulsified GTF liposome preparations had decreased levels of dental caries compared with control animals given empty liposomes. Rats given dehydrated/rehydrated or purified liposomal GTF also had significantly less caries than control group (GTF alone). Because of economy, ease of preparation and efficiency in amount of antigen used, filtered, dehydrated/ rehydrated and purified liposomal GTF preparations are most practical for use in further assessing the efficacy of liposomal GTF in oral immunization.