Vaccines bacterial

Production of the bacteria and the bacterial components of bacterial vaccines... 

The bacteria and bacterial components needed for the manufacture of bacterial vaccines are readily prepared in laboratory media by well-recognized fermentation methods. The end-product of the fermentation, the harvest, is processed to provide a concentrated and purified vaccine component that may be conveniently stored for long periods or even traded as an article of commerce. 

The single-component bacterial vaccines are listed in Table 15.1. For each vaccine, notes are provided of the basic material fkm which the vaccine is made, the salient production processes and tests for potency and for safety. The multicomponent vaccines that are made by blending together two or more of the single component vaccines are required to meet the potency and safety requirements for each of the single components that they contain. The best known of the combined bacterial vaccines is the adsorbed diphtheria, tetanus and pertussis vaccine (DTPerWac/Ads) that is used to immunize infants, and the adsorbed diphtheria and tetanus vaccine (DTWac/Ads) that is used to reinforce the immunity of school entrants. 

The single-component viral vaccines are listed in Table 15.2 with notes similar to those provided with the bacterial vaccines. The only eombined viral vaeeine that is widely used is the measles, mumps and rubella vaccine (MMR Vac). In a sense, however, both the inactivated (Salk) poliovaccine (PoWac (inactivated)) and the live (Sabin) poliovaccine (PolWac (oral)) are combined vaccines in that they are both mixtures of vims of each of the three serotypes of poliovims. Influenza vaeeines, too, are eombined vaccines in that many contain components fiom as many as three vims strains, usually fiom two strains of influenza A and one strain of influenza B. 

Table 15.1 Bacterial vaccines used for the prevention of infectious disease in humans. Vaccines marked are those used in conventionai immunization scheduies those marked f are used to provide additionai protection when circumstances indicate a need... 

Bacterial vaccines less generally available than those listed in the table include botulism vaccine, necrotizing enteritis... 

Viral vaccines present problems of safety testing far more complex than those experienced with bacterial vaccines. With killed viral vaccines the potential hazards are those due to incomplete virus inactivation and the consequent presence of residual live virus in the preparation. The tests used to detect such live virus consist of the inoculation of susceptible tissue cultures and of susceptible animals. The cultures are examined for cytopathic effects and the animals for symptoms of disease and histological evidence of infection at autopsy. This test is of particular importance in inactivated poliomyelitis vaccine, the vaccine being injected intraspinally into monkeys. At autopsy, sections of brain and spinal cord are examined microscopically for the histological lesions indicative of proliferating poliovirus. 

Finished-product biopharmaceuticals, along with other pharmaceuticals intended for parenteral administration, must be sterile (the one exception being live bacterial vaccines). The presence of microorganisms in the final product is unacceptable for a number of reasons ... 

Woodard, L.F., Surface Chemistry and Classification of Vaccine Adjuvants and Vehicles, in Bacterial Vaccines, A. Mizrahi, ed., Alan R. Liss, New York, 281, 1990. 

Currently available live vaccines include measles, mumps, polio, rubella, vaccinia (smallpox), varicella (chickenpox), and yellow fever. All of these are made from viruses. There are two live bacterial vaccines 1) Bacillus of Calmette and Guerin (BCG) vaccine for tuberculosis and 2) oral typhoid. 

The strength of bacterial vaccines may be expressed in one of three different forms, each of which is correlated with the dosage regimen and schedule of specific vaccines on the basis of theoretical computations and clinical trials. 

Similar to bacterial vaccines, the strength of viral vaccines may be expressed in the total amount (p,g) of virus or immunogen present in each mL or dose (e.g., influenza vaccines). 

Killed (bacterial) vaccine Typhoid, cholera, pertussis, plague, meningitis. 

Other Bacterial vaccines and toxoids 1 Viral vaccines J Rickettsial vaccines Antisera Antiviral protein (interferon) Prophylaxis Therapy Chemotherapy Subunit vaccines sometimes available... 

Walsh (2003) defined biopharmaceuticals as therapeutic protein or nucleic acid preparations made by techniques involving recombinant deoxyribonucleic acid (DNA) technology. Therapeutic proteins include blood clotting factors and plasminogen activators, hemopoietic factors, hormones, interferons and interleukins, and monoclonal antibodies (LeVine, 2006). Over time, the term biopharmaceutical has broadened, and, in addition to proteins and nucleic acids, now includes bacteriophages, viral and bacterial vaccines, vectors for gene therapy, and cells for cell therapy (Primrose and Twyman, 2004). Attention here focuses on proteins, since the majority of approved biopharmaceuticals are proteins. 

Given that anti-endotoxin antibodies may provide benefit under various clinical conditions, we prepared a subunit LPS vaccine from the J5 mutant. Previous experience with whole, killed Gram negative bacterial vaccines (e.g. typhoid, cholera and Salmonella Re vaccines) demonstrated a high degree of reactogenicity... 

Whole cell, killed bacterial vaccines previously given to humans were generally of limited immunogenicity. While many of the adverse reactions with these preparations were described as acceptable, the frequency of systemic reactions (25%) in healthy individuals might give one pause before using them in larger patient populations. Several studies have administered whole bacterial, killed... 

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