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PubMed1984

A study of the skin reaction to bacterial vaccine in perennial rhinitis.

Immediate and late skin reactions to a bacterial vaccine test were studied in perennial rhinitis patients. The incidence of late skin response was 17.6% when 0.1 ml of bacterial vaccine was tested. The incidence of positive immediate reaction was similar to the late reaction but there was no significant association between these two types of reaction. There was no correlation between the skin reaction to bacterial extract and the presence of pathogenic and microflora in the nose and throat of the patient. Statistical analysis also showed that there was no significant correlation between the results of the skin test to bacterial vaccine and to common allergenic extracts.

Adolescent↗
PubMed1998

Review of current preclinical testing strategies for bacterial vaccines.

A wide variety of bacterial vaccines is in various stages of preclinical and clinical development. These products range from whole killed or live attenuated bacterial organisms to purified proteins, peptides and plasmid DNA. Although preclinical strategies may be directed by a set of common guidelines focused on demonstrating safety and biological activity, the exact developmental scheme will depend on product-specific characteristics. In general, preclinical data should support the proposed clinical formulation and include detailed information on the source and quality of starting materials, manufacturing processes, characterization of bacterial seed stocks, potency, general safety, purity, and identity. Data describing product validation and testing may be appropriate depending on the type of product, e.g., genetic stability for recombinant constructs, details on inactivation or attenuation methods for organisms or toxins, demonstration of potency of combination products, and safety and toxicology studies of plasmid DNA vaccines or vaccines with novel adjuvants. The choice of dose, route, and formulation to be used clinically may be greatly affected by rigorous preclinical developmental strategies.

Adjuvants, Immunologic↗
PubMedDate not supplied

[use of a Staphylococcus bacterial vaccine in pediatric patients with chronic sinusitis].

INTRODUCTION: The antigenic extracts of bacterial vaccine (Staphylococcus aureus) they increase the phagocitosis, the immunoglobulins concentrations and they help in the immunologic response. OBJECTIVE: To determine the effectiveness of the bacterial vaccine in patient pediatric with chronic sinusitis. MATERIAL AND METHOD: Through a prospective, observational, descriptive and logitudinal study 50 patients were studied with clinical and radiological diagnosis of chronic sinusitis in the period of May from 1997 to July of 1998; they talked to three outlines of antibiotics, they were made studies of cytology hematic, of snot, perspired pharyngeal and immunoglobulin determination and x-rays of breasts paranasals. The extract of 0.1 ml was applied twice up to 0.5 ml per week, subcutaneous trial during eight months, with pursuit of six months and control of cytology hematic, as well as immunoglobulin determination. RESULTS: 82% (41) of the patients they improved and nine (18%) they persisted with symptoms, of these five required the antimicrobials prescription, three tonsillectomi. There was an immunoglobulin increment, mainly of the IgA and IgG in 38 (76%) patient.

Child↗
PubMed1993

Potency testing of bacterial vaccines for human use.

The potency tests for bacterial vaccines are quite diverse. For some products (pertussis, cholera, anthrax, typhoid and BCG vaccines) these are specified as Additional Standards in the Code of Federal Regulations. For other products (tetanus and diphtheria toxoids, plague vaccine) the testing is done according to so-called Minimum Requirements, which have less regulatory authority than Additional Standards. Still other products (e.g., polysaccharide conjugate vaccines, acellular pertussis vaccine, live oral typhoid) are tested according to individualized criteria that are contained in their specific Product License Applications. For some products there is inadequate knowledge of the pathogenic mechanisms and/or protective factors to design valid in vitro potency tests. In these cases, animal testing with subsequent serologic evaluation or challenge testing is often necessary. Examples would include vaccines such as cholera and plague vaccines. The FDA supports the elimination of animal testing when suitable alternatives are available. Thus, many of the potency tests, especially for newer products, rely on in vitro characterization. For example, the immunogenicity of conventional polysaccharide vaccines is largely proportional to their molecular weight. Potency testing therefore relies heavily on physical characterization in terms of composition, molecular weight, and quantity.

Animals↗
PubMed1988

Lectins and their role in a new polyvalent bacterial vaccine against ARI.

The potency of the polyvalent bacterial vaccine (Infectvac) to prevent lethal infections with S. pneumoniae ATCC 6301 was examined. NMRI-mice were protected 2-5 times better than untreated controls. The protection is based on activation of resistance-mechanisms, e.g. interferon production. Most interesting is a strong activation of the phagocytosis-killing-system of alveolar macrophages after oral application of antigen (information: gut mucosa to lung mucosa). Using the same infection model the important role of bacterial lectins for infectious diseases was demonstrated. Blocking the combining site of the bacterial lectin of S. pneumoniae by intranasal application of N-acetylglucosamine (the specific carbohydrate for the lectin) was able to prevent a lethal infection with S. pneumoniae 3-times better than PBS or using not lectin relevant carbohydrates. Therefore, blocking the lectin receptor with specific carbohydrates might also be of clinical relevance to prevent acute respiratory infections (ARI).

Administration, Oral↗
PubMedDate not supplied

[Phagocytic activity of mouse peritoneal macrophages under administration of bacterial vaccines and prospidin].

Phagocytic activity of peritoneal macrophages in cases of separate and combined injections of killed bacterial vaccines and prospidin has been studied in the work. As a result of researches conducted, it has been found out that the injection of vaccines together with prospidin makes it possible to reduce an inhibiting effect of prospidin on phagocytic activity of monocyte-macrophagal cells; first of all it concerns their digestive activity. Thus, the immunodepressing effect of antiblastome drugs may be reduced with the help of injection of killed bacterial vaccines which stimulate nonspecific factors of organism protection, including antineoplastic ones.

Animals↗
PubMed1991

Preliminary result of mixed bacterial vaccine as adjuvant treatment of hepatocellular carcinoma.

Mixed bacterial vaccine (MBV) was employed in the multi-modality treatment of hepatocellular carcinoma (HCC) during 1985-1988. Thirty eight patients undergoing palliative resection and cisplatin therapy (Series 1) and 48 patients with unresectable HCC who received hepatic artery ligation + intraarterial cisplatin infusion + radiotherapy (Series 2) were randomized to receive MBV or not. In series 1, the 1- and 2-year survival rates of MBV group and control were 75% vs 58% (P = 0.19) and 45% vs 39% (P = 0.23). In series 2, the 1-, 2- and 3-year survival rates were 59%, 41% and 41% for MBV group and 39%, 25% and 20% for the control, respectively (P1 = 0.07, P2 = 0.09, P3 = 0.07). In addition, MBV improved the "second look" resection rate to 40% as compared to 17% in the control (P greater than 0.05). MBV could also prevent such immunosuppression as decrease of macrophage activity caused by radiotherapy. We consider MBV a potential nonspecific immunostimulant in the multimodality treatment of HCC.

Adult↗
PubMed1973

Enhanced effect of repeated administration of bacterial vaccine against viral respiratory infection.

Administration of a standard bacterial vaccine (SBV) affords some protection against influenza infection in mice if given 4 to 5 h before inoculation of the virus. This effect was enhanced by repeated injections of SBV 7 and 14 days earlier, as measured by the length of survival, mortality rate, development of gross pneumonia, and virus multiplication in the lungs. Serum interferon levels were likewise enhanced by immunization with SBV, which may, at least in part, explain the increased preventive effect.

Animals↗
PubMed1987

Observations on the combined systemic administration of mixed bacterial vaccine, bacillus Calmette-Guerin, transfer factor, and lymphoblastoid lymphocytes to patients with cancer, 1974-1985.

Herein are reported the results of treating 139 cancer patients with combined immunomodulation that consisted of bacillus Calmette-Guerin, transfer factor, and mixed bacterial vaccine. In addition 28 patients were given infusions of lymphoblastoid lymphocytes. Patients were admitted to this treatment program who either had failed to respond to other modalities, had elected to add immunomodulation to usual therapy, or had refused chemotherapy and/or radiation therapy. The results suggested that combined immunomodulation therapy is well tolerated and safe and that this approach on a prima facie basis had a salutary effect on the courses of a number of the patients treated. The results also illustrate alternative pathways that can be taken by patients and physicians who are not comfortable with protocolized double-blind methods of approaching patients with poor prognosis cancer.

Adolescent↗
PubMed1993

Clinical results and immunologic effects of a mixed bacterial vaccine in cancer patients.

A biological response modifier, mixed bacterial vaccine (MBV), derived from Streptococcus pyogenes and Serratia marcescens was used as a single agent in the treatment of 11 patients with refractory malignancies. MBV's effect on interleukin-2 (IL-2) production, plasma interferon (IFN) and tumor necrosis factor (TNF) levels was monitored. Most patients' peripheral blood mononuclear cells continued to produce baseline to elevated levels of IL-2, in spite of age and disease status. Several patients maintained moderate to high IFN levels. In general there was little correlation between IL-2 and IFN levels or with the response to therapy. One of 11 patients had minor response, 1 of 11 had partial response, 4 of 11 had temporary stabilization of disease, and 5 of 11 had progressive disease. A patient with AIDS and Kaposi's sarcoma experienced a dramatic improvement in performance status and disease stabilization. In all patients side effects occurred only following i.v. and not i.m. administration and included fever and chills. No adverse hepatic, renal or hematologic effects were observed. MBV is a well-tolerated biological response modifier with modest activity in advanced human tumors.

Adult↗
PubMed1989

[Immunologic indicators in the treatment of recurrent respiratory diseases using peroral bacterial vaccines].

The authors treated on account of relapsing respiratory diseases 95 children with Broncho-vaxom (Lab. ltd. Meyrin, Geneva) and 75 children with bacterial vaccine prepared with regard to the microbiological examination. Restoration or improvement of the clinical condition was achieved in 80% of the patients. No side-effects were observed during treatment. As to investigated immunological indicators they recorded after treatment a significant reduction of IgM (P less than 0.001), IgA (P less than 0.01), SIgA in saliva (P less than 0.01), values of the nitroblue tetrazolium test (P less than 0.01) and (P less than 0.05). The assembled data revealed that bacterial vaccines are useful as immunomodulating preparations.

Adjuvants, Immunologic↗
PubMed2004

Biological products; bacterial vaccines and toxoids; implementation of efficacy review. Final rule and final order.

The Food and Drug Administration (FDA) is amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids that have standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).

Antitoxins↗
PubMed1963

A NEW APPROACH TO BACTERIAL VACCINES.

Immunizing antigens against only 10 bacterial diseases-cholera, diphtheria, paratyphoid, pertussis, plague, scarlet fever, staphylococcal disease, tetanus, tuberculosis and typhoid-have been licensed for sale in Canada and the United States. Convincing evidence of efficacy is available for only four of these-diphtheria and tetanus toxoids, and pertussis and typhoid vaccines.The principles which determine the efficacy of different immunizing antigens are not always the same. Toxoids, for example, stimulate the formation of antitoxin-producing mechanisms which can neutralize toxins produced by invading organisms, thereby rendering them harmless. Conversely, vaccines stimulate the formation of antibacterial mechanisms which stop the growth of organisms before they can produce disease.Use of enzyme-lysed vaccines for prevention of staphylococcal disease represents a new approach in vaccine research. Animal tests have shown lysed vaccines to be 10 to 100 times less toxic, and about eight times more effective, than whole bacterial vaccines. Studies with lysed vaccines for other diseases are now in progress.

Antigen-Antibody Reactions↗
PubMed1982

[Comparative study of various routes of vaccination and testing. An instance of a killed bacterial vaccine].

The efficiency of intranasal subcutaneous, aerosol and digestive vaccinations with killed Klebsiella pneumoniae as vaccine was studied on the survival curves after experimental disease with pathogen K. pneumoniae I inoculated by the same routes. Results show that the local immunization is an important factor of protection and the intranasal route is very convenient.

Administration, Intranasal↗
PubMed1990

[Treatment of adult type atopic dermatitis (AD) with bacterial vaccine prepared from individual cases (I)--Clinical study].

Bacteria on the skin surface are well known to be one of the precipitating factors of AD. We have treated 68 severe cases of adult type AD with bacterial vaccines prepared for individual cases. Bacteria were collected from lesional skin of each individual and cultured. More than 50% of cases (36/68) showed improvement clearly. Five out of 9 cases without topical steroid showed good response to this treatment. In regard to its clinical response it is suggested that the treatment should be continued for at least 1-2 years, because these cases treated for less than 1 year have high risk of recurrence. Five cases responded excellent showed complete remission of dermatitis for 10 months to 2 years after stopping of this treatment. These results suggest that bacterial vaccine can be beneficial for the treatment of severe cases of adult type AD, which did not respond to other therapy.

Adolescent↗