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PubMed2003

Adverse effects of BCG vaccination; mainly BCG infection.

(1) Local and regional adverse effects (ulceration, abscesses and adenitis are generally mild, although they can persist for more than three months. Systemic effects are rare but potentially life-threatening (osteitis, disseminated BCG infection, anaphylaxis, etc.). (2) Some risk factors are related to the vaccine itself or to its administration (intradermal route, certain strains of vaccine, high doses, etc.). There are very few data on the adverse effects of multipuncture BCG administration. (3) The frequency of adverse effects is inversely related to age at vaccination. The vaccine can cause severe disseminated BCG infection, especially in subjects with congenital or acquired immunodeficiency (notably HIV infection and immunosuppressive therapy). (4) The risk of adverse effects can be minimised by avoiding patients with contraindications and by careful administration.

BCG Vaccine↗

PubMed2004

[Intravesical Bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation for carcinoma in situ of the bladder: results with 6 successive instillations of 40 mg BCG].

We performed a study to evaluate the usefulness of intravesical Bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation on carcinoma in situ (CIS) of the bladder. Between 1998 and 2003, 43 patients were treated for CIS of the bladder with a median follow-up period of 45 months (range: 12 to 69 months). The patients (35 males and 8 females) ranged in age from 45 to 89 years (average: 67.5 years). They underwent intravesical instillation of 40 mg of BCG once a week for 6 weeks. A complete response (CR) was achieved in 83.7% of the patients. Among these patients, 97.2% and 70.7% remained recurrence-free during follow up for one year and three years, respectively. The median duration of CR was 31.5 months. Although total cystectomy was performed on 1 patient, none of the patients died of bladder cancer. Adverse effects included bladder irritability in 48.8%, pyuria in 46.5%, gross hematuria in 18.6%, and fever (temperature over 37.5 degrees C) in 9.3%. No clinically significant side effects were observed. These results indicate that intravesical instillation of BCG at a dose of 40 mg given 6 times was as effective as the routine dose of 80 mg, and could decrease systemic adverse effects such as high fever.

Administration, Intravesical↗

PubMed2004

Delivering a selective neonatal BCG vaccination programme in a multi-ethnic community: an audit of the neonatal BCG immunisation programme in Birmingham and Solihull.

Neonatal bacillus Calmette-Guérin (BCG) immunisation is a primary preventive measure against tuberculosis. Local health professionals expressed concern about the variability of knowledge regarding eligible infants and uptake of the vaccine. A questionnaire was sent out to health visitors for use at the routine visit to babies. Details requested included ethnic group and country of origin of the infant, eligibility for BCG vaccination, and vaccination status. BCG vaccination was indicated for 41% of newborns. In total 74% of these eligible infants received the vaccine with a range of 36-83% between the five maternity units. There were inconsistencies within maternity units in identifying high-risk groups by ethnicity and country of origin, resulting in low coverage in certain eligible groups. Confusion exists about which infants are at risk of tuberculosis and should be vaccinated. Current national guidelines are not specific enough for cases of interracial parenting and for the increasingly diverse countries of origin of the population. In the absence of clearer national guidelines there is a need for pragmatic local guidance.

BCG Vaccine↗

PubMed1987

Immunization of mice with Mycobacterium leprae/Mycobacterium bovis BCG admixtures: modulation of the acquired response to BCG.

The generation of acquired immunity to BCG in mice was compared to that in animals receiving an admixture of BCG and killed Mycobacterium leprae. No significant qualitative differences were observed between the two groups in terms of their generation of delayed sensitivity, of protective T cells, and of immunological memory. In addition, the admixture was as effective as BCG in conferring protective immunity against certain nontuberculous mycobacteria, and in one case, that of M. avium 706, significantly augmented protection.

Animals↗

PubMed1979

Suppressed or enhanced antibody responses in vitro after BCG treatment of mice: importance of BCG viability.

Mycobacterium bovis, BCG, is known to be capable of either enhancing or suppressing various immune responses. Using a standard technique and number of organisms, some of the parameters predetermining whether enhancement or supression will occur have been investigated. Dead BCG given intravenously into mice caused an enhancement of the antibody response in vitro to sheep erythrocytes. In contrast, the same number of viable organisms caused suppression if given intravenously but enhancement if given subcutaneously. The inclusion of 25% or more killed organisms in an intravenous inoculum of fully viable organisms changed suppression to enhancement. Treatment of BCG infected mice with streptomycin lessened the suppression but did not change it to enhancement. The possible causes of suppression are discussed.

Animals↗

PubMed1978

[BCG vaccination and leukemia. Epidemiologic studies on the effect of BCG vaccination on leukemia].

The possible influence of BCG vaccination on leukemia mortality of infants was investigated by various authors. The methods used were prospective trials, retrospective studies and epidemiological analyses. In some of these studies a protective effect of BCG vaccination was observed, in other studies no influence was found. Up to now this problem is subject to controversial discussions. An epidemiological analysis of the Austrian data using trend analyses, regression analyses and analyses of rank correlation showed an inverse correlation between BCG vaccination rate of newborns and leukemia mortality in the age group 0--5 years. From this correlation a protection rate of 0.77 could be calculated.

Austria↗

PubMed1977

Comparison of the toxic effect on mice of a massive dose of French BCG after low, medium and high dose pretreatment of the French, Glaxo and Japan BCG strains.

Numerous laboratory experiments and field trials for tuberculosis prevention have been analyzed. The results concern the comparison of different BCG strains, the correlation between the protection and allergenic property and the degree of residual virulence as an inherited character in producing post vaccination side effects. There are more and more reports about incidence of side effects following BCG immunostimulation. We used the French, Glaxo and International Reference (Japan) strains for this toxicity test because these are the most used strains for vaccine production. The differences obtained in toxic effects of the three tested BCG strains in this experimental model suggest that the investigations should be continued and comparative analyses with histological and immunochemical methods should be extended.

Animals↗

PubMed1997

Antineoplastic activity of BCG: location of antineoplastic glycans in the cellular integument of Mycobacterium bovis, BCG vaccine, Connaught substrain.

The polysaccharidic integument surrounding growing cells of attenuated Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccine, Connaught substrain, can be removed with non-specific proteases. After 5 weeks incubation at 37 degrees C in Middlebrook 7H-9 medium, the collected cells were incubated with pronase and the integument and cells separated by centrifugation in a Ficoll-Histopaque preparation. After washing and drying, the detached integument accounted for 65% w/w of the original dried cell mass. Like the original cellular material, the detached integument manifested antineoplastic activity against a murine sarcoma model in vivo. Solubilization of the otherwise insoluble integument by boiling in water or by digestion in 8 M urea significantly enhanced activity of the integument itself, by 125 and 1,100 times, respectively. Integument extracts were shown to contain mainly glucose, with smaller quantities of other sugars, consistent with the presence in BCG of high molecular weight glycans, as previously reported. It is suggested that most, if not all, of the antineoplastic activity of BCG can be accounted for by the activity associated with the high-molecular weight polysaccharidic glycans which constitute the cellular integument.

Animals↗

PubMedDate not supplied

A case of BCG sepsis with bone marrow and liver involvement after intravesical BCG instillation.

The case described concerns a 68-year-old male patient, who received intravesical BCG instillations for non-resectable urothelial carcinoma (stage pT1, G2). After the third instillation, which was complicated by hematuria during catheterization, he had a high temperature, dyspnoea, a weight-loss of 15 kg and critical recurrent hypotension for 3 weeks. On admission to the clinic he presented with high serum liver enzymes and pancytopenia. The suspected diagnosis of BCG sepsis was confirmed by the detection of typical granulomas in liver and bone marrow histology. After initiation of tuberculostatic therapy, the patient's condition improved and laboratory results returned to normal. This case shows the potential of a life-threatening systemic side effect after intravesical BCG instillation.

Aged↗

PubMedDate not supplied

[BCG test reaction in previously BCG Moreaux-Rio de Janeiro-vaccinated healthy children].

BCG-test reaction was carried out in 91 non-tuberculous children between 2 and 11 years old, who had received BCG vaccination during the first six months of life to critically evaluate the usefulness of this test in Pediatric practice. The BCG-test profile of the vaccinated group was shown to have a unimodal distribution, varying from 3 to 17 millimeters, with a median of 6 millimeters. It was demonstrated that the degree of reaction decreases with time. Nevertheless, false-positives could be expected in a significant percentage when reactions larger than 10 millimeters are considered as a cutoff. The specificity can be increased using only reactions with diameter equal or greater than 15 millimeters as an indicator of tuberculous disease.

English Abstract↗

PubMed1992

Human phagocyte respiratory burst by Mycobacterium bovis BCG and M. leprae: functional activation by BCG is mediated by complement and its receptors on monocytes.

We have measured the role of serum components on two parameters of the phagocytosis reaction: a) the chemiluminescence (CL) response associated with the oxidative respiratory burst in response to Mycobacterium bovis BCG and M. leprae, and b) the uptake of these two mycobacteria by healthy human monocytes. Pre-incubations of fresh or heat-inactivated serum or serum containing EGTA or EDTA indicate that these two mycobacteria activate the alternative complement pathway. Monoclonal antibodies against CR1 and CR3 inhibit the responses of M. bovis BCG and M. leprae, demonstrating that complement receptors mediate the phagocytosis of these two mycobacteria. Thus, complement and its receptors on the surface of the monocytes (CR1 and CR3) are important in the functional activation of phagocytosis of M. bovis BCG and M. leprae.

Antibodies, Monoclonal↗

PubMed1984

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.

Antibody Formation↗

PubMed1979

Regression of established oral tumors after intralesional injection of living BCG or BCG cell walls.

Oral tumors with associated cervical lymph node metastases developed after injection of tumor cells into buccal pads of inbred guinea pigs. Intralesional injection of living BCG or BCG cell walls (CW) caused regression of established tumors, prevented the development of cervical lymph node metastases and led to the development of host resistance to the growth of subsequent tumor transplant.

Animals↗

PubMedDate not supplied

[BCG-induced inflammation during childhood and in pregnancy. Additionally a contribution to BCG-induced necrotising cerebral arteritis].

In the third year of life of a girl vaccinated neonatally against tuberculosis an abscess of the associated lymph nodes appeared which contained acid-fast bacilli. After extirpation of the lymph nodes weeks later an intestinal BCG-dissemination was observed which seemed to be cured under a brief tuberculostatic therapy. At the age of 22 years a left sided hemiplegia due to aneurysms and thrombosis of 2 cerebral arteries was seen. At autopsy in the adventitia of the arteria basilaris macrophages were discovered which showed intracellular acid-fast bacilli. A paralysis of the oculomotor nerve appearing later was also caused by this brain lesion. Towards the end of a pregnancy a serious BCG-dissemination in the intestines relapsed. A healthy premature child was born. Massive tuberculostatic therapy was inefficient. The woman died in her 27th year of life. A defective function of the macrophages is suggested for the immunological abnormality.

Adult↗

PubMed1997

Ulceration of a previously healed BCG scar in suspected disseminated BCG infection.

A 2.5-year-old boy with disseminated tuberculosis, highly suspected to be disseminated BCG infection which occurred against a background of secondary immunodeficiency due to measles and malnutrition, is presented. The initial diagnosis was post-measles bronchopneumonia, meningitis and marasmus. The final diagnosis was arrived at only because of a high clinical index of suspicion of tuberculosis which is needed in all communities with a high prevalence of tuberculosis. The absence of AIDS and the extreme rarity of ulceration of a previously healed BCG scar are noted.

BCG Vaccine↗

PubMed1993

Use of maintenance intravesical bacillus Calmette-Guérin (BCG), with or without intradermal BCG, in patients with recurrent superficial bladder cancer. Long-term follow-up of a randomized phase 2 study.

To study maintenance Bacillus Calmette-Guérin (BCG) therapy we treated 49 patients with recurrent superficial bladder cancer pTa and/or carcinoma in situ, failing previous intravesical chemotherapy. They received 20 intravesical instillations in 1 year, with or without 6 intradermal inoculations. Side effects were frequent, causing treatment stop in 14 patients (29%). Drug-induced cystitis was the most frequent side effect, seen in 29 patients (59%). Forty-two patients were evaluable for response. During the first 2 years of the study 14 patients (33%) had one (n = 8) or more (n = 6) recurrences. A total of 18 patients (43%) remained recurrence free with a median follow-up of 47 months. Progression was seen in 2 patients from pTa to pT1, another patient died of metastatic bladder cancer after 47 months. PPD skin test conversion was of no prognostic value. The use of intradermal inoculations caused no significant increase of toxicity and had no effect on efficacy, however, both groups were small. It caused no local side effects. We conclude that maintenance BCG therapy can be useful for patients with recurrent superficial bladder cancer failing previous intravesical chemotherapy.

Administration, Cutaneous↗

PubMed1992

Origins of BCG surface charge: effect of ionic strength and chemical modifications on zeta potential of Mycobacterium bovis BCG, Tice substrain, cells.

The zeta potential of washed Tice substrain BCG organisms was measured over a range of ionic strengths from I = 0.005 to 0.1 M. No change in the isoelectric point of 3.4-3.7 was evident. Proteolytic enzymes (trypsin/chymotrypsin, pepsin, papain and pronase) and fluorodinitrobenzene abolished the cationic charge, suggesting that this is substantially due to amino groups associated with protein. Neither hot HCI nor cold trichloroacetic acid affected the charge, indicating that ionic groups are not associated with extractable polysaccharides. Methanolysis, treatment with HF and carbodiimide, and cationic detergent (cetyltrimethylammonium bromide) binding indicated that the negative charge was provided by carboxylic acids, phosphoesters and strong acidic groups, possibly sulphates. Standardless quantitative X-ray microanalysis revealed the presence of phosphorus and sulphur on the surface of actively growing BCG colonies.

BCG Vaccine↗

PubMed1982

Mycobacterial antibodies after tuberculin testing, BCG- vaccination, BCG-immunotherapy and against cross-reacting antigens in a solid-phase radioimmunoassay.

A solid-phase radioimmunoassay (SPRIA) was used to investigate several factors influencing false positive and negative results in serodiagnostic test for tuberculosis, Unheated cytoplasmic fractions of mycobacteria, and other microorganisms were bound to polystyrol and antibody binding of sera from tuberculous, non tuberculous hospitalized patients and healthy adults was tested by the SPRIA-method. The level of antibody concentration in the SPRIA reflects roughly cross-reactivity between the antigens. Similar antibody binding occurred with M. tuberculosis, M. bovis, M. ulcerans and several "atyical" mycobacteria as test antigens, while other mycobacterial species and one of two tested tuberculin preparation (PPD) showed less antibody binding capacity. Significant cross-reactivity of fourty to sixty per cent was found between M. tuberculosis and N. asteroides but no cross-reaction was observed with C. parvum, S. typhi, S. paratyphi, C. Albicans or Aspergillus niger. Heating of mycobacterial cytoplasmic antigen resulted in a decrease of the test specifity. Tuberculin testing and intracutaneous BCG-vaccination in healthy adults had no distinct influence on the antibody response against several mycobacterial test antigens. However, a rapid increase of antibody levels was documented in melanoma patients after BCG-immunotherapy by sacrification with a more concentrated vaccine.

Antibodies, Bacterial↗