Biologic

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Biologics

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immunizing agents - living source - biologic processes: antibiotic, hormones, and vitamins

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Code of Federal Regulations

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vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells - virus, therapeutic serum, toxin, antitoxin, or analogous

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Natural Immunity

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that are inborn: Species • Racial - Individual immunity

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Species immunity:

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specific to species. E.g., Antrax (in cattle, sheep, horses), plague (in rodents), and rabies (cat, dog, bat)

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Racial immunity:

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human race differ in susceptibility to common infections (e.g., yellow fever, TB, pneumonia),

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Individual immunity:

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some individual has little capacity to resist skin disorders, common cold and other familiar diseases

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Humoral Immunity

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development of antibodies in response to exposure (vaccination) or the transmission of antibodies (mother)

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Active immunity:

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develops in response to antigenic substances in the body by its own production of antibodie

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Acquired Immunity

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involves humoral immunity (B-cells) and cell-mediated immunity (T-cells) - Naturally occurred: by accident -- Artificially occurred: specific vaccine or toxoids -

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Passive immunity:

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the transfer of readymade antibodies or occur naturally thru the placenta

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Vaccines

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of attenuated (live) or inactivated (killed) or fractions of microorganisms

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How food, drug, antigen, and vaccines are absorbed in body

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90% of absorption occurs in the small intestine - Microvilli further increase surface area

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GALT

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The gut associated lymphoid tissue has Peyer's patches (PP).

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Peyer's patches (PP)

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as immune sensors of intestine

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PP functions

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like induction of immune tolerance or defense against pathogens

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Different type of vaccines

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1. Bacterial vaccines 2. Viral vaccines 3. VLP (Virus like particle) vaccine 4. Cancer vaccines

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Inactivated bacteria:

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is grown and treated with phenol or formaldehyde and heat. Then centrifuge and suspended in sterile water or 0.9% sodium chloride solution.

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Live bacteria:

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genetic alteration (several base pair in DNA is deleted or altered) - bacteria to survive and multiply but not to produce disease.

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Viral Vaccine

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animated media (embroynic egg, cell cultures of chick embryo, human deployed cell culture, skin of living calves, and intact mice)

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Subviron vaccine

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three influenza virus strain: Influenza A (H1N1), Inffluenza A (H3N2), Influenza B.

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Virus-like particle

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do not contain any viral genetic material. The expression of viral structural proteins, such as Envelope or Capsid

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Human papilloma virus - Gene therapy

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Small non-enveloped, double-stranded DNA virus -- sexual contact -- six early genes (E1, E2, E4, E5, E6, and E7) two late (L1 and L2) genes, and a non-coding long control region (LCR)

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Gardasil (Merck) More Guard better 4

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20 μg HPV 6 - 40 μg HPV 11 - 40 μg HPV 16 - 20 μg HPV 18

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Cervarix (GSK) -

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20 μg HPV 16 - 20 μg HPV 18

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Cancer vaccine use --

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complement to surgery, radiation therapy, and chemotherapy AND prevent cancer in patients in high risk because of familial disease.

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Cancer vaccine synth -- B7-CD28

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one single cell suffer mutations and not foreign -- Need constimulatory signals to destroy the tumor B7-CD28-CTLT 28

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Cancer vaccine properties

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T-cells, lymphokine-activated killer cells, and natural killer cells have antitumor activity. recognize tumor-associated antigens (TAAs) -- and stimulate these immune cells instead of antibody producing cells

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Three catagories of TAAs

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1. patient specific, 2. tumor specific, and 3. Shared.

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Cancer vaccines types:

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1.Autologous tumor vaccines 2.Allogeneic tumor vaccines 3.Anti-idiotypic vaccines 4.Gene therapy

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Auto-logous tumor vaccines auto most exp -- Provenge

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isolated and attenuated from the tumor of the patient Very expensive - Provenge for Prostate cancer $93000 to live in 3 months

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Allogeneic tumor vaccines Allo-alike

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from the cell lines that express tumor specific TAAs - either the fragment of the allogenic tumor cell or the whole cells are injected.

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Anti-idiotypic vaccines -- Anti: Ab-Ag adjuvant

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three dimensional immunogenic regions on the antibody that binds the antigen and combined with an adjuvant -- get the Ag then make coresponding Ab and inject to pateint

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Gene therapy - HPV

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DNA template is placed in a cell which is transcribed into messenger RNA, and expressed as costimulatory protein •This protein stimulates immune response. --•Example is quadrivalent human Papilloma Vaccine (HPV),

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Toxoids -- Anatoxine (Tdap botulism)

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weakened or suppressed bacterial toxin (usually an exotoxin) by chemical (formalin) or heat. Keep immunogenicity - Anatoxine. prevention of diphtheria, tetanus and botulism

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Human sera and globulins (Homologous sera)

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Ig and hyper-immune sera (blood)use a specific biologic product for specific diseases

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Animal Immune Sera (Heterologus sera) - Horse: antitoxin - antivennin

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Inject toxin to horses take the Ig for immuno active -- toxoid-exotins

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Administration and toxicity

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The sterility -- hypersenitivity (pruritis-itchy or urticaria-itchy, red welts, bronchospasm, respiratory distress, laryngeal edema, circulatory collapse and death.)

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•Thimerosal

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(containing 49.6% w/v) has been used in vaccines as preservative for long time.

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Childhood immunization vaccines

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Hepatitis B - Tdap (95% immuned College) - Flu B - MMR (Preschool) - smallpox and Polio (no more) - Rotavirus

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Adult immunization vaccines

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influenza -•Pheumococcal disease •Tetanus, diphtheria, and acellular pertussis •Varicella zoster •Herpes zoster
•Lyme disease •Human papillomavirus

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Diagnostic skin antigen -- Candida Albicans (HIV) -- Multi skin test Ag -- Merieux-MUltitest CMI,

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Ag in viVo (live) -- intradermally -- positive rxn induration size, vesiculation - necrosis