[The use of BCG vaccine in the treatment of surface tumors of the bladder]. / Primenenie vaktsiny BTsZh v lechenii poverkhnostnykh opukholei mochevogo puzyria.

The paper presented results of the treatment of 110 patients with vesical surface tumors, 85 of them were postoperatively treated according to the regime suggested by Adolphs and Bastian and slightly modified for patients with relapsing vesical tumors. For the therapeutic or preventive effect (after TUR or transvesical electrical resection of the urinary bladder surface tumors), the authors used for 6 weeks after the operation intravesical instillations of BCG vaccine ("Calgevax", Bulgarian production) in a weekly dose of 120 mg per 50 ml of the serum. Previously, for this purpose intravenous injections of cyclophosphamide had been routinely used in a dose of 700 mg/m2 during 2 postsurgery weeks. Intracutaneous vaccinations were performed simultaneously. The follow-up which lasted from 18 to 48 months revealed tumor relapses only in 26 per cent of those under study. The patients with relapses were repeatedly operated on, but their postsurgical management was modified: 2 intravesical instillations of 120 mg of BCG vaccine during the first month after the surgery and then monthly instillations of the same dosages for the whole of the year followed. A subsequent 14-26-month follow-up revealed no relapse of the tumors. The authors concluded that the use of BCG vaccine was a practicable part of the combined treatment of patients with vesical surface tumors.

BCG vaccine therapy for treatment of superficial bladder cancer.

A total of 42 patients were involved in the study of the effectiveness of BCG vaccine on superficial bladder tumours. The new Bulgarian vaccine CALGEVAX was administered intravesically in consecutive instillations once weekly and then once monthly for a period of 11 months. For intradermal application the F-70 subcellular preparation was used. On the grounds of their initial experience in the treatment of superficial bladder tumours with unspecific immunotherapy the authors would like to express their confidence in the effectiveness of the intravesical application of BCG vaccine.

Studies on the biological activity of two strains of BCG: influence of production conditions.

Batches of freeze-dried BCG vaccine were produced by using two different substrains--Moscow (SL 374a) and Paris (SL 1173 P2). The biological activity of the vaccines was studied by the following tests: In the laboratory--viability, heat stability, homogeneity, skin reactivity, allergenic potency and immunogenicity in guinea pigs. In the field--local lesions and postvaccination tuberculin sensitivity. All the batches were produced by using the same technique and production methods. The Paris substrain vaccines showed less viability, but higher heat stability and skin reactivity. It is to be noted that when the VKL medium was used (instead of Sauton) the Paris substrain vaccines showed much lower immunogenicity in guinea pigs and, at the same time, much higher skin reactivity. In the field studies the Moscow substrain vaccines showed higher local lesions and tuberculin sensitivity. In other experiments vaccines produced from the same substrain (Moscow) but in different production centers were compared. It was found that the vaccines differed (according to the production methods used) in terms of some laboratory tests (viability, heat stability, homogeneity) but these differences were not associated with significant differences when studied in the field.

Nonspecific immunomodulating effects of BCG vaccine on antibody-dependent cell-mediated cytotoxicity.

The effects of BCG vaccine on antibody-dependent cell mediated cytotoxic (ADCC) activity of spleen lymphocytes were examined after BCG treatment. A modified plaque assay method, using sheep red blood cells (SRBC) as targets and IgG antibodies from rabbit anti-SRBC serum, was applied. The changes of ADCC activity were different in spleen lymphocytes according to the route and the timing of the administration of the vaccine. Following i.p. administration we observed an immunosuppressive effect in mouse and rat spleen effector cells within the first seven days. The ADCC activity level returned to normal by the 14th day. The cytolytic activity was maximal at the 21st day after treatment, and decreased slowly thereafter. The ADCC activity of mouse spleen lymphocytes did not change within the first seven days after i.v. BCG administration while the maximal cytolytic activity was induced on the 14th day but it was lower than the peak value found after i.p. treatment.

Immunological monitoring of melanoma patients on BCG immunotherapy. I. Enzyme-linked immunosorbent assay of human sera after BCG-treatment.

Purified lipopolysaccharide (LPS), isolated from BCG and purified protein derivative of tuberculin (PPD) were used as antigens in an enzyme-linked immunosorbent assay (ELISA) of sera from patients with malignant melanoma undergoing immunotherapy with BCG. It was found that LPS and ELISA are useful tools in the monitoring of humoral immune response against BCG.

Hemagglutination antigen of Mycobacterium tuberculosis. Immunochemical characterization and concanavalin A reactivity.

The hemagglutination antigen isolated from Mycobacterium tuberculosis strain Aoyama B was characterized by immunoelectrophoresis using the International Reference System for Mycobacterial Antigens. It showed two precipitin bands, the major one being identical with antigen 1 (arabinomannan). The minor precipitin band formed a spur with antigen 2 (arabinogalactan), attesting to the presence of common determinant groups. The immunoelectrophoretic analysis of the hemagglutination antigen against concanavalin A also revealed 2 precipitin bands, the major one being identical with the single precipitin band formed between the reference antigen and concanavalin A. The 2 arabinomannans present seemed to differ in molecular weight.