biologic and immunomodulators (chapter 12)

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BIOLOGICS AND IMMUNOMODULATORS STEPHANIE LAURETE

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BIOLOGICS are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods . can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Are substances strictly defined and interpreted by the Center for Drugs and Biologics of the Federal Food and Drug Administration (FDA) under Public Health Act of 1994, as amended. “any virus, therapeutic serum, toxin, antitoxin, or a nalagous p roduct.”

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BIOLOGICS Includes immunizing biologics that are derivatives of Animals Serum Antitoxin Globulins Microscopic plant organisms Vaccines Toxins toxoids

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Biologics can be classified into two general categories: Antigen Antibodies

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Antigen The term originally came from Anti body Gen erator. Is a substance that, when introduced into the tissue of human, cause the formation of antibodies by the immune system . can enter the body through the respiratory tract, digestive tract, skin, or blood vessels. The most common antigens are proteins such as those found in bacteria and viruses. Must possess a high molecular weight (more than 10, 000 Daltons) . Then those compounds with a molecular weight lower than required weight can be a partial antigen, which is called “ hapten ”.

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Antigen possesses two biologic properties: Immunogenicity -the capacity to induce antibody formation. Specificity -governed by small chemical sites on the antigen molecule called the “antigenic determinants” or “ epitopes ”

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Classifications of Antigen: Exogenous antigens -are antigens that have entered the body from the outside, for example by inhalation, ingestion, or injection. Endogenous antigens -are antigens that have been generated within previously-normal cells as a result of normal cell metabolism, or because of viral or intracellular bacterial infection. Autoantigen - is usually a normal protein or complex of proteins (and sometimes DNA or RNA) that is recognized by the immune system of patients suffering from a specific autoimmune disease.

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Antibodies also known as an immunoglobulin , is a large Y-shaped protein used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. React specifically with antigen that stimulated their production. recognizes a unique part of the foreign target, termed an antigen . Are found predominantly in the serum fraction of the blood, although they also exist in other body fluids and in association, with other tissues, such as lymph nodes and mucous membrane. Produced by a type of specialized white blood cells called B cells that allow the immune system to remeber an antigen and respond faster upon future exposure.

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Each antibody binds to a specific antigen; an interaction similar to a lock and key.

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NAME DESCRIPTION IgA Found in mucosal areas, such as the gut, respiratory tract and urogenital tract, and prevents colonization by pathogens. Also found in saliva, tears, and breast milk. IgD Functions mainly as an antigen receptor on B cells that have not been exposed to antigens. It has been shown to activate basophils and mast cells to produce antimicrobial factors. IgE Binds to allergens and triggers histamine release from mast cells and basophils , and is involved in allergy. Also protects against parasitic worms. IgG In its four forms, provides the majority of antibody-based immunity against invading pathogens. The only antibody capable of crossing the placenta to give passive immunity to fetus . IgM The most abundant of the serum immunoglubulins , and the major part (up to 80%) of the serum antibody found after bacterial and viral infections belongs to this class of antibodies. It e liminates pathogens in the early stages of B cell mediated ( humoral ) immunity before there is sufficient IgG . Immunoglobulin can be separated into five subclasses:

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The basic functional unit of each antibody is an immunoglobulin ( Ig ) .. monomer(containing only one Ig unit); dimeric with two Ig units; or pentameric with five Ig units,

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IMMUNITY resistance to disease or a body's ability to resist a disease may exist naturally or as a result of inoculation or previous infection.

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Two major types of Immunity: Natural (innate) immunity -describes the defence mechanism that are present in the body because of race, species specificity, and a multiple of other factors not easily defined, but it does not include any mechanisms especially developed during the lifetime of the individual. Acquired (adaptive) immunity -is quite specific and generally divided into two classes: Active Immunity Naturally acquired active Artificially acquired active Passive Immunity Naturally acquired active Artificially acquired active

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Active Immunity Means the specific immunity developed by an individual in response to the introduction of antigenic substances into the body. Naturally acquired active the antigenic substance received by the body in a natural manner. Artificially acquired active the antigenic substances received by the body through the administration of vaccine.

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Passive Immunity is the type developed by the introduction of performed antibodies (not antigens) into the body. Naturally acquired active is not self developed but is passed from one individual to another. Artificially acquired active is a short-term immunization induced by the transfer of antibodies, which can be administered in several forms; as human or animal blood plasma, as pooled human immunoglobulin for intravenous (IVIG) or intramuscular (IG) use, and in the form of monoclonal antibodies ( MAb ).

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VACCINES are used as inoculation to stimulate the production of antibodies.

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Different Types of Vaccines attenuated (weakened) live whole organisms (bacteria or viruses) killed or inactivated organisms harmless organisms related to the pathogen that induce cross-immunity isolated structural components or products of organisms, which sometimes are conjugated to proteins to increase immunogenicity (called “conjugated vaccines) recombinant live vaccines synthetic vaccines.

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Composition of Currently Used Products for Active Immunization Vaccine Type Measles ( rubeola ) Live virus Mumps Live virus Rubella Live virus Oral poliovirus (OPV) Live virus Inactivated poliovirus (IPV) Inactivated virus Influenza virus Whole virus, subvirion (split virus), purified surface antigens Yellow fever Live attenuated virus Hepatitis B Recombinant surface antigens Varicella zoster Live virus Rabies Inactivated virus Pneumococcal Extracted polysaccharides (23 – valent ) Haemophius b conjugate Isolated polysaccharides conjugated to carrier proteins Plague Formaldehyde – inactivated Yersinia typhoid Live attenuated Salmonella typhi Meningococcal Extracted polysaccharides from serogroups A, C, Y, and W of Neisseria meningtidis Tetanus Adsorbed toxoid Diphtheria Adsorbed toxoid Pertussis (whole cell) ( acellular ) Killed whole cell Inactivated toxins ( toxoid ) and filamentous hemagglutinin of Bordetella pertussis BCG Attenuated live Mycobacterium bovis

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Classifications of Vaccines: prophylactic therapeutic

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Viral Vaccines protect individuals from disease by eliciting an immune response, which will prevent disease if an individual is subsequently infected with a disease-causing strain of the virus.

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RECOMMENDED IMMUNIZATION SCHEDULE FOR CHILD Immunizing Agent Preferred Age for Initial Dose Dosage for Primary Immunization Booster Adsorbed diphtheria and tetanus toxoids and pertussis vaccine (DTP) 2 to 3 months 0.5 mL , intramuscularly, repeated twice at 4-to 8-week intervals 0.5 mL year after primary and 4 to 5 years later, Td every 10 years thereafter Adsorbed tetanus and diphtheria toxoids for adult use (Td) 7 years and over 0.5 mL intramuscularly, repeated once after 4 to 8 weeks 0.5 mL year after primary and every 10 years thereafter Live oral poliovirus vaccine, trivalent 2 to 3 months Two closes given at not less than 8-week interval (in the volume indicated in the labeling ), and a third, reinforcing close 8 to 12 months later One close at entry into school Live attenuated measles virus vaccine 15 months of age or older 1000 TCID subcutaneously At ages 4-6 and/or upon entry to middle school Live rubella virus vaccine Between age 15 months and puberty 1000 TCID subcutaneously At ages 4-6 and/or upon entry to middle school Live mumps virus vaccine 15 months of age or older 1000 TCID subcutaneously At ages 4-6 and/or upon entry to middle school Haemophilus b vaccine 2-3 months 0.5 mL , intramuscularly, repeated twice at 8-week intervals At 12-15 months of age Hepatitis B vaccine Birth 0.25-0.5 mL , intramuscularly , repeat at 1-2 months and 6- 18 months No routine boosters recommended

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Age Vaccine Comments 2 d ays Hepatitis B – 1 st dose The current recommendation is that all infants receive Hepatitis B vaccine; infants born to hepatitis-antigen positive mothers should also receive Hepatitis B immunoglobulin 1 month Hepatitis B – 2 nd dose 2 months DTwP – 1 st dose OPV – 1 st dose Hib – 1 st dose DTwP and Hib may be combined in a single product 4 months DTwP – 2 nd dose OPV – 2 nd dose Hib – 1 nd dose DTwP and Hib may be combined in a single product 6 months DTwP – 3 rd dose Hiv – 3 rd dose DTwP and Hib may be combined in a single product 12 months Hib – 4 th dose (if PedvaxHIB is used) Hepatitis B – 3 rd dose 16 months OPV – 3 rd dose DTwP – 4 th dose Hib -4 th dose 9 if HibTITER or OmniHIB is used) MMr – 1 st dose Can be anytime between 6 to 8 months May use DWaP 6 years DTaP – 5 th dose OPV – 4 th dose MMR At entry to school 12 years MMr At entry to middle school 16 years Td Repeat every 10 years throughout life Recommended Immunization Schedule for Normal Infants and Children by Age of Adminitration

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Variety of Media used in Manufacturing of Viral Vaccines: Whole animal substrates such as embryonated eggs Primary cells derived from animal tissue such as chick embryo fibroblasts Cell lines in culture such as Vero cells, derived from monkey kidneys

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Viral Vaccines Prophylaxis against yellow fever measles rubella mumps Smallpox varicella Polio influenza Rabies Hep B Hep A Attenuated Killed or inactivated

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Smallpox Synonym: cowpox Definition: is the only disease that has been completely wiped out throughout the world. Causes: variola virus Smallpox Vaccine Definition: is the living virus of vaccinia (cowpox) that has been grown in the skin of a vaccinated bovine calf. Composition: attenuated live whole variola virus Duration of Immunity: 7 years

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Rabies Definition: is a viral disease that causes acute encephalitis (inflammation of the brain) in warm-blooded animals. Causes: Rhabdovirus Rabies Vaccine Synonym: human diploid cell rabies vaccines (HDCV) Definition:i s a sterile lyophilized preparation of either the whole virion of subvirion . Composition: Inactivated or killed viruses Duration of Immunity : 3 years

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Yellow Fever Synonym: Yellow Jack Definition: is an acute viral hemorrhagic disease that is  transmitted by the bite of female mosquitoes (the yellow fever mosquito, Aedes aegypti , and other species) Causes: Flavivirus Yellow Fever Vaccine Definition : is an attenuated strain of living yellow fever virus, selected for high antigenic activity and safety that is prepared by culturing the virus in the living embryo of domestic fowl (Gallus domesticus ) Composition: attenuated virus Duration of Immunity: 30-35 years

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Influenza Synonym: flu Definition: is an infectious disease that  is transmitted through the air by coughs or sneezes, creating aerosols containing the virus. Causes: Influenza virus Influenza Virus Vaccine Definition: is a sterile, aqueous suspension or suitably inactivated influenza virus types A and B, either individually or combined, or virus subunits prepared from the extra embryonic fluid of influenza virus infected embryo (called “split virus” or “ subvirus ”, and/or purified surface antigens. Composition: inactivated or killed Duration of Immunity: 1 year

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Poliomyelitis Synonym: Polio; Infantile paralysis ; Post-polio syndrome Definition: is a viral disease that can affect nerves and can lead to partial or full paralysis. Causes: Polio virus ( Enterovirus ) Poliovirus Vaccine Inactivated: Salk Definition: is a sterile suspension of inactivated poliomyelitis virus of types 1,2 and 3 from the virus strain that are grown separately in primary culture of Rhea monkey kidney tissues. Composition: inactivated or killed Duration of Immunity: long lasting

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Poliovirus Vaccine Live Oral Synonym: trivalent oral polio vaccine (TOPV) Definition: is a preparation of one or combination of the three types of live, attenuated polioviruses Composition: attenuated Duration of Immunity: longer lasting immunity than Salk

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Measles Synonym: rubeola or morbilli Definition: is an infection of the respiratory system caused by a virus Causes: paramyxovirus Measles Virus Vaccine Live Synonym: Rubeola Vaccine Definition: is prepared by attenuated derived from the original Edmonton B strain and that is recommended for active immunization for children of 15 months or older. Composition: attenuated Duration of Immunity: more than 13 years

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Rubella Virus Vaccine Live Synonyms: German Measles Vaccine Definition: is prepared from the Wistar Institute RA 27/3 strain grown on human diploid cell tissue and recommended for children aged 1 to puberty. Composition: attenuated Duration of Immunity: more than 13 years Mumps Virus Vaccine Live Synonyms: German Measles Vaccine Definition: is prepared with the B-levels Jeryl Lynn strain of thr virus, which is grown in cell cultures of chicken embryo tissue. Composition: attenuated Duration of Immunity: at least 10 years

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Hepatitis B Synonym: serum hepatitis Definition: is an infectious illness caused by hepatitis B virus (HBV) which infects the liver of hominoidea , including humans, and causes an inflammation called hepatitis. Causes: Hepatitis B virus (HBV) - hepadnavirus Hepatitis B Vaccine Definition: is composed of chemically inactivated hepatitis B surface antigen ( HBsAg ) particles. Composition: killed or inactivated Duration of Immunity: 5 years

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Hepatitis A Synonym: infectious hepatitis Definition: is an acute infectious disease of the liver caused by the hepatitis A virus (Hep A), an RNA virus, usually spread the fecal -oral route; transmitted person-to-person by ingestion of contaminated food or water or through direct contact with an infectious person. Causes: hepatitis A virus Hepatitis A Vaccine Definition: contains inactivated Hepatitis A virus which stimulates active immunity against a future infection. Composition: killed or inactivated Duration of Immunity: 10 years or more

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Varicella Synonym: chickenpox Definition: is a viral infection in which a person develops extremely itchy blisters all over the body. It used to be one of the classic childhood diseases. Causes: varicella -zoster virus herpes zoster (shingles) in adults. Varicella Virus Vaccine Live Definition: is a preparation of the Oka/Merck strain of live, attenuated varicella virus that was initially obtained from a child with natural varicella , then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures andfinally propagated in human diploid cell cultures Composition: attenuated virus Duration of Immunity: 10 years

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Recommended Immunization Schedule for Adults Immunizing Agent Indications for Use Dosage Adsorbed tetanus and diphtheria toxoids for adult use (td) Every adult Primary immunization : 0.5 mL intamuscularly , repeated once after 4-8 weeks, then once 6-12 months later, Booster every 10 years Live attenuated measles virus vaccine Unimmunized young women 1000 TCID 50 subcutaneously Lice rubella virus vaccine influenza virus vaccine Patients with diabetes or other metabolic diseases, severe anemia , or chronic pulmonary, cardiovascular, or renal disease, immunocompromised patients, those in chronic care facilities, and everyone over 65 years of age 1000 TCID50 subcutaneously 0.5 intramuscularly annually Polyvalent pneumococcal vaccine Patients w/ chronic cardiac or pulmonary disease, alcoholism, cirrhosis, diabetes, Hodgkin's disease, nephritic syndrome, renal failure, cerebrospinal fluid leaks, immunosuppression , asymptomatic or symptomatic HIV infection, and everyone over 65 years of age 0.5 mL subcutaneously or intramuscularly Hepatitis B vaccine Medical and laboratory workers w/ frequent exposure to blood or blood product, intravenous drug abusers, male homosexuals, dialysis patients, recipients of non-recombinant, blood-derived proteins, mortuary workers, residents and staff of institutions for the mentally retarded, and immunocompromised patients 1 mL intramuscularly in deltoid muscle, repeated after 4 weeks and again 6 months after first dose Hepatitis A vaccine Travelers to endemic areas other high risk patients 1 mL dose in deltoid muscle, repeated 6 to 12 months later Varicella virus vaccine Healthy adults who have not had varicella infection Two doses 4 to 8 weeks apart

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Rickettsial Vaccines are cultured in chick embryos or in monkey kidneys tissue cultures in a manner similar to that for virus.

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Rickettsial Vaccines are vaccines for the prevention of diseases caused by various species of RICKETTSIA is a genus of non-motile, Gram-negative, non- sporeforming , highlypleomorphic bacteria that can present as cocci (0.1 μm in diameter), rods (1–4 μm long) or thread-like (10 μm long). is carried by many ticks, fleas, and lice .

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Bacterial vaccine Consists of suspension of attenuated or more commonly killed pathogenic bacteria in isotonic sodium chloride solution or other suitable diluents. Other bacteria vaccines involve antigenic portion of the bacteria, either isolated by chemical extraction or produce via biotechnology.

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Good immunologic response are obtained in the following bacteria vaccine: > petussis >dengue >typhoid >tetanus > pnumocal and > haemophilus influenzae

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The effectiveness o f BCG vaccine and meningitis vaccine are still being evaluated. Many of these involve biotechnology in producing either altered (attenuated) bacteria through gene deletion or purified antigenic.

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Typhoid vaccine There are two vaccines to prevent typhoid: inactivated (killed) vaccine gotten as a shot live, attenuated (weakened) vaccine which is taken orally (by mouth)

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Precautions: Anyone who has had a severe reaction to a previous dose of this vaccine should not get another dose. •Anyone whose immune system is weakened should not get this vaccine. They should get the inactivated typhoid vaccine instead. These people include anyone who: --Has HIV/AIDS or another disease that affects the immune system. --Is being treated with drugs that affect the immune system, such as steroids, for 2 weeks or longer. --Has any kind of cancer. --Is taking cancer treatment with x-rays or drugs. •Oral typhoid vaccine should not be given within 24 hours of certain antibiotics. Ask your doctor or nurse for more information.

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Cholera Vaccine i s a sterile suspension of killed cholera vibrios ( vibrio cholerae ) in isotonic sodium chloride or other suitable diluent.it is prepared from equal portion of suspension of cholera vibrios of the Inaba and Ogawa strains.Cholera vaccine is an active immunizing agent in the development of immunity to the disease. The vaccine is only aboit 50% effective and then only 3 to 6 months. The world health Organization no longer recommends cholera vaccine prior to travel cholera-in- fected areas, because the risk of acquiring cholera is low.

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Plague Vaccine have been used since the late 19th century, but their effectiveness has never been measured precisely. Field experience indicates that vaccination with plague vaccine reduces the incidence and severity of disease resulting from the bite of infected fleas. The degree of protection afforded against primary pneumonic infection is not known. Persons exposed to plague patients who have pneumonia or to Yersinia pestis *** aerosols in the laboratory should be given a 7- to 10-day course of antimicrobic therapy regardless of vaccination history. Recommended antimicrobials include tetracycline’s, chloramphenicol , or streptomycin.

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The plague vaccine licensed for use in the United States is prepared from Y. pestis organisms grown in artificial media, inactivated with formaldehyde, and preserved in 0.5% phenol. The vaccine contains trace amounts of beef-heart extract, yeast extract, agar, and peptones and peptides of soya and casein. Serum antibody to Fraction I capsular antigen, as measured by the passive hemagglutination (PHA) test, is correlated with resistance to Y. pestis infection in experimental animals. A comparable correlation between PHA titer and immunity probably occurs in humans.

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Tuberculosis vaccination A vaccination for tuberculosis (TB). The vaccine, known as BCG ( bacille Calmette Guerin), is used in most developing countries to reduce the severe consequences of TB in infants and children. However, BCG vaccine has variable efficacy in preventing the adult forms of TB and is, therefore, not routinely recommended for use in the US and other developed countries.

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Bacille Calmette Guérin : An effective immunization against tuberculosis. Commonly abbreviated BCG, it is an attenuated (weakened) version of abacterium called Mycobacterium bovis which is closely related to Mycobacterium tuberculosis, the agent responsible for tuberculosis.

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Camille Guérin (1872-1961) and Albert Calmette (1863-1933) produced the BCG strain of the bacteria at the Pasteur Institute in Paris in 1921. Within a decade BCG was being given in France and many other countries. By 1928, BCG had been given to 116,000 infants in France alone. However, conflicting reports about its effectiveness delayed the use of the BCG vaccine in the United States until 1950.BCG is also used as an adjuvant to stimulate the immune response and in cancer chemotherapy.

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Meningococcal Polysaccharide Vaccines Bacterial polysaccharides, including those comprising the N. meningitidis capsule, are T-lymphocyte-independent antigens. T-lymphocyte-independent antigens stimulate mature B lymphocytes but not T lymphocytes, producing an immunologic response that is neither long lasting nor characterized by an anamnestic response. As a result, meningococcal polysaccharide vaccines have several inherent limitations. First, they do not confer long-lasting immunity among persons of any age ] The serogroup A polysaccharide induces antibody in some children as young as 3 months of age, and may provide short term protection.The serogroup C polysaccharide is poorly immunogenic in young children, with little or no efficacy among infants and children less than 24 months of age. Multiple doses of serogroup A and C polysaccharide vaccine may cause immunologic hyporesponsiveness to the A and C polysaccharides, although clinical implications of this phenomenon are not known. Finally, meningococcal polysaccharide vaccines do not cause a sustainable reduction of nasopharyngeal carriage of N. meningitidis , and therefore do not substantially interrupt transmission to elicit herd immunity.

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Pneumococcal Vaccine Polyvalent is a sterile, liquid vaccine for intramuscular or subcutaneous injection.

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Pneumococcal Vaccine Polyvalent It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumonias , including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States.

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This includes: Immunocompetent adults who are at increased risk of developing pneumococcal disease or its complication because or chronic illness. Adults older than 65 years of age. Immunocompromise children and adults. Children with sickle cell disease and Asymptomatic or symptomatic HIV infected patients older than 2 years of age. Even with current antibiotic therapy, the mortality rate in high risk patients hospitalized with pneumococcal infection has remained higher thaw 25% supporting the use of a vaccine.

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Toxins and Toxoid Toxins may assist the parent bacteria to combat host defense systems, to increase the supply of certain nutrients such as iron, to invade cells or tissues, or to spread between hosts. Sometimes the damage suffered by the host organism has no obvious benefit to the bacteria. For example, botulinal neurotoxin in spoiled food may kill the person or animal that eats it long after the parent bacteria have died. In such situations it is assumed that the bacteria benefit from the toxin in some other habitat and that the damage to vertebrates is accidental.

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Certain bacterial and plant toxins have the unusual ability to catalyze chemical reactions inside animal cells. Such toxins are always composed of two functionally distinct parts termed A and B, and they are often called A-B toxins. The B part binds to receptor molecules on the animal cell surface and positions the toxin upon the cell membrane. Subsequently, the enzymically active A portion of the toxin crosses the animal cell membrane and catalyzes some intracellular chemical reaction that disrupts the cell physiology or causes cell death. See also Immunologic cytotoxicity .

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Toxoid , bacterial poison (toxin) that is no longer active but retains the property of combining with or stimulating the formation of antibodies. In many bacterial diseases the bacteria itself remains sequestered in one part of the body but produces a poison ( exotoxin ) that causes the disease manifestations. Heating this poison or treating the poison with chemicals converts the exotoxin into a harmless toxoid ; when the toxoid is injected into the body, it causes the formation of antibodies that will also react with the active toxin and thus confer immunity from subsequent infection.

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Toxoid , are used extensively in the production of vaccines , the most prominent examples being the toxoids of diphtheria and tetanus , which are often given in a combined vaccine . used in modern vaccines are commonly obtained by incubating toxins with formaldehyde at 37° C (98.6° F) for several weeks.

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Diagnostic Antigens A number of antigen-containing preparations are employed as diagnostic aids to determine whether an individual has developed hypersensitivity to certain types of organism. Hypersensitivity is usually the result of a previous infection caused by the specific etiologic agent. Small quantities of the diagnostic preparation are usually injected intradermally , and the developing reaction is usually read at 48 hours, although observations at 24 hours and at 72 hours are often helpful. The usual type of positive response is a localize, well-defined wheal accompanied by erythema .

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PASSIVE IMMUNOLOGICALS are antibodies that have been performed in response to exposure to a given organism and have been isolated from the producing animal (human).

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ANTISERUM Antibodies prepared from non-human sources. IMMUNE SERUM human antibodies preparations. ANTITOXIN prepared from the blood of animals usually horses, that have been immunized by repeated injections of specific bacterial exotoxins

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DIPHTERIA ANTITOXIN Is a sterile, nonpyrogenic solution of the refines and concentrated proteins, chiefly Globulins, containing antitoxic antibodies obtained from the blood serum or plasma of healthy horses that have been immunized against diphtheria toxin or toxoid .

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TETANUS ANTITOXIN Is a sterila , nonpyrogenic solution of the refined and concentrated proteins employed in the treatment and prophylaxis of tetanus.

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BOTULISM ANTITOXIN Obtained from the blood serum or plasma of healthy horses that have been immunized AGAINST the toxins produces by both the type A and type B or type E strains of Clostridium Botulinum .

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SNAKE VENINS OR VENOMS Are obtained by holding a poisonous snake over a conical glass container covered with a sheer of thin rubber where the snake penetrates with it fangs, where the semi-liquid venom is ejected into the container.

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ANTIVENIN (CROTALIDAE) POLYVALENT or NORTH AND SOUTH AMERICA ANTISNAKEBITE SERUM A sterile, nonpyrogenic preparation derived by drying afrozen solution of specific venom-neutralizing Globulins obtained from the serum of healthy horses immunized against venoms of four species of pit vipers: CROTALUS ATROX (WESTERN DIAMOND BACK) C. ADAMANTEUS (FLORIDA DIAMOND BACK) C. DURISSUS TERRIFICUS (SOUTH AMERICAN RATTLESNAKE) BOTHROPS ATROX (SOUTH AMERICAN FER-DE-LANCE)

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ANTIVENIN (MICRUCUS FULVIUS) or NORTH AMERICA CORAL SNAKE ANTIVENIN Obtained from the seum of healthy horses that have been immunized with the venom of micrucus fulvius , the eastern coal snake. This preparation also neutralized the venom of M. Fulvius tenere (Texas coral snake), but does nott neatralize the venom of micruroides euryxanthus .

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ANTIVENIN ( Latrodectus Mactans ) or BLACK WIDOW SPIDER ANTIVENIN Obtained from horses immunized against the venom of the black widow spider.

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IMMUNE GLOBULINS Are immunizing biologics that contain specific antibodies derives from the blood of human who have survived an attack of a specific disease or who have been immunized in some other manner. May be obtained from the plasma or serum pool of a large number of random donors or from a limited numbers of individuals who have been hyperimmunized against a specific antigenic material.

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IMMUNE GLOBULIN, IMMUNE SERUM GLOBULIN (HUMAN), IMMUNE GLOBULIN INTRAMUSCULAR OR GAMMS GLOBULIN contains many antibodies normally present in adult human blood. IMMUNE GLOBULIN INTRAVENOUS (IGIV) Provides immediate antibody levels, whereas intramuscular administration involves a 2 to 5 day delay before adequate serum levels are attained. TETANUS IMMUNE GLOBULIN OR TETANUS IMMNUE GLUBOLIN (HUMAN) Derived from the blood plasma of adult human donors who have been immunized with tetanus toxoid

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RABIES IMMUNE GLOBULIN Solution of antirabies globulin concentrated by cold alcohol fractionation from plasma of donors hyperimmunizes with rabies vaccine. HEPATITIS B IMMUNE GLOBULIN Prepared from pooled plasma obtained from donors with high titers of antibody hepatitis B surface antigen. VARICELLA- ZOSTER IMMUNE GLOBULIN Globulin fraction of human plasma, primarily immunoglobulin G, found in routine screning of normal volunteer blood donors.

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Rh o (D) IMMUNE GLOBULIN Derived from human blood plasma containing antibody to the erythrocyte factor Rh o (D) LYMPHOCYTES IMMUNE GLOBULIN or ANTITHYMOCYTE GLOBULIN (EQUINE) Is a lymphocyte selective immunosuppressant that is prepared by immunizing horses with human thymus cells and then isolating the equine gamma globulin. CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (CM6- IGIV) Is used for the attenuation of primary cytomegalovirus disease in patients who have received a kidney transplant.

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MONOCLONAL ANTIBODIES Present the opportunity to provide passive immunization with antibodies grown in culture instead of isolated from animals or humans.

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Antibody preparations: MUROMONAB- CD3 Is a murine (mouse-derived) monoclonal antibody to the CD3 antigen of human T-cells. 2. ABCIXIMAB Is a FAB (fragment antigen binding) fragment of the chimeric human murine monoclonal antibody 7E3, that has recently been approved for use as an adjunct to pecutaneous transluminal angioplasty to prevent abrupt closure of the treated coronary vessel.

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IMMUNOMODULATORS also known as “biological response modifiers” these are substances that modify the immune response in the body.

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Categories for these substances: COLONY- STIMULATING FACTORS (CSFs) INTERLEUKINS INTERFERONS CYCLOSPORIN A & TACROLIMUS (FK506)

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COLONY- STIMULATING FACTORS (CSFs) Are proteins involved in the production and differentation of stem cells in thee bone marrow into various types of blood cells. GRANULOCYTE STIMULATING FACTOR (GSF) Is a 174-amino-acid residue Glycoprotein normally produced in the body by monocytes , fibroblasts, and endothelial cells. Its generic name is FILGRASTIN, 7 sold as NEUPOGEN GRANULOCYTE- MACROPHAGE STIMULATING FACTOR (GM-CSF) Is a 127-amino-acidrecidue glycoprotein whose generis name is SARGRAMOSTIN. Stimulates the hematopoietic- cells in the granulocyte-macrophages pathways to divide and differentiate, and also stimulates and activates mature macrophafes and granulocytes. ERYTHROPOIETIN (EPOIETIN ALFA) Is a glycoprotein normally produces in the kidney that stimulates the division and differentiation of eythroid percusor cellls in the bone marrow.

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INTERLEUKINS Are a family of cytokines that are critical to the communication network between cells involves in the immune response. Interleukin -2(ALDESLEUKIN) Sold as Proleukin ; is approved for use in metastatic renal cell carcinoma. Produces by recombinant DNA technology in E. Coli. Adverse Effects: More serious side effects: *Fever & chills *myocardial infraction * Pruritus *bowel perforation *Gastrointestinal Adverse Effects *CNS effects *renal & liver dysfuction

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INTERFERONS Are protein cyclokines with molecular weights ranging from 15,000 to 21,000 daltons pronounced by a variety of cell types in response to a variety of stinuli , includingviral infections, bacterial toxins and some intracellular pathogens. Interferon –A Interferon Beta -1b ( Betaseron ) Interferon Gamma -1b ( Actimmune )

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Interferon –A Is not directly antiviral; it is released in response to viral infection or other stimuli. 3 forms of Interferon –a Recombinant Interferon Alfa –Ra ( Roferon A) Produced by recombinant E. Coli 7 is approved for use in hairy cell Leukemia and Aids- related Kaposis Sarcoma. Recombinant Interferon Alfa -2b ( Intron A) Interferon Alfa –n3 ( Alfaferon N) Interferon Beta -1b ( Betaseron ) containing gene obtained from human fibroblast. Has both antiviral 7 immuno regulatory properties but if it is currently approves only for use in relapsing – remitting multiple sclerosis. Interferon Gamma -1b ( Actimmune ) is a 140-amino-acid lymphokine also produces by using recombinant E.Coli . Uses for chronic granulaomatous disease.

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CYCLOSPORIN A & TACROLIMUS (FK506) are immunosuppresants used in prophylaxis organ rejection. a cyclic polypepetie consisting of 11 amino acids. both drugs are used to inhibit T- lymphocyte 7 prevent rejection of transplanteorgan .

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