Clinico-immunological trials of Pseudomonas aeruginosa vaccine.

Pseudomonas aeruginosa vaccine (PV) containing predominantly cell-wall protein protective antigens was tested for safety and immunogenicity by immunization of 119 volunteers. The criteria for safety and immunogenicity were the absence of serious post-vaccinal reactions or complications either during immunization or 12 months later. There were mild (19 donors or 15.9%) and moderate (three donors or 2.5%) febrile reactions after immunization and in two volunteers the body temperature increased up to 38 degrees C, however it decreased to normal values within 24 h. We observed in 43 (36.1%) of volunteers mild and in five (4.2%) moderate local reactions which disappeared within 24 h. Using the ELISA and passive mouse protection test it was shown that PV induces the formation of specific antibodies. A high level of specific antibodies persisted for the 5-month period of observation. The antibody titres increased in 94-97% of volunteers and moreover in 45.6% the antibody titres (the number of ELISA units) increased 2.5-3-fold and more. Anti-P. aeruginosa plasma was used for the treatment of 46 patients with severe forms of P. aeruginosa infection (40 adults and six infants aged up to 2 years) and 87% of the patients recovered.