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IMMUNIZATION PREPARED BY: DR. SALMA ELGAZZAR - Learning objectives Define the following terms and understand their significance : a. Active and Passive immunization b. Booster immunization, toxoid and antitoxin c. Killed, live and attenuated vaccine .d. Conjugated and unconjugated vaccine Discuss the indications for administration, appropriate dosage schedule, possible side effects and contraindications for use of the commonly used vaccine Describe the standard vaccination schedule for the Ministry of health and World health organization Identify the indications of the less commonly used vaccines .a. Meningococcal vaccination .b. Rota Vaccination and RSV immunoglobulibn c. Influenza virus vaccination d. Rabies vaccine . Overview of the Immune Response PASSIVE IMMUNIZATION Passive immunity is the transfer of ready-made antibodies, from one individual to another. Passive immunity can occur naturally, when maternal antibodies are transferred to the fetus through the placenta. It is induced artificially: when high levels of human (or horse) antibodies specific for a pathogenor toxin are transferred to non-immune individuals. INDICATIONS Passive immunization is often used: When there is a high risk of infection and insufficient time for the body to develop its own immune response. To reduce the symptoms of ongoing diseases or immunosuppressive diseases. In children who have weakened immune systems or may not be good candidates for routine vaccinations for other reasons. It can be used with people who haven’t been vaccinated against a disease to which they’ve been exposed. To treat poisoning. For example The passive rabies immunization (rabies immune globulin) is commonly used after a certain type of wild animal bites a child. Passive immunizations for hepatitis A (gamma globulin) may be helpful for people traveling to a part of the world where hepatitis A is common. They are typically given before children or adults leave on their trip. These are used less now that there is a vaccine for hepatitis A. Artificially acquired passive immunity is a short-term immunization achieved by the transfer of antibodies, which can be administered in several forms: • Human or animal blood plasma or serum. • Pooled human immunoglobulin for intravenous (IVIG) or intramuscular (IG) use. • High-titer human IVIG or IG from immunized donors or from donors recovering from the disease. • Monoclonal antibodies (MAb). FDA approved products for passive immunization and immunotherapy DISEASE PRODUCT SOURCE USE Treatment of wound and food borne forms of botulism, infant botulism is treated with human botulism immune globulin (BabyBIG) Botulism Specific equine IgG Horse Cytomegaloviru -s (CMV) hyper-immune IVIG human Prophylaxis, used most often in kidney transplant patients. Hepatitis A Measles Pooled human Ig human serum Prevention of Hepatitis A and measles infection, treatment of congenital or acquired immunodeficiency. Hepatitis B Hepatitis B Ig human Post-exposure prophylaxis, prevention in high-risk infants (administered with Hepatitis B vaccine). human serum Treatment of ITP and Kawasaki disease, prevention/treatment of opportunistic infection with IgG deficiency. ITP, Kawasaki Pooled human disease and IgG IgG deficiency DISEASE PRODUCT SOURCE USE Rabies Rabies Ig human Tetanus Vaccinia Tetanus Ig Vaccinia Ig human human Post-exposure prophylaxis (administered with rabies vaccine). Treatment of tetanus infection. Treatment of progressive vaccinia infection including eczema and occular forms (usually resulting from smallpox vaccination in immunocom promised individuals). Varicella (chickenpox) Varicellazoster Ig human Post-exposure prophylaxis in high risk individuals. DISADVANTGES: Immunity derived from passive immunization lasts for a few weeks or months. There is also a potential risk for hypersensitivity reactions, and serum sickness, especially from gamma globulin of non-human origin. Passive immunity provides immediate protection, but the body does not develop memory, therefore the patient is at risk of being infected by the same pathogen later. Injection site reactions following receipt of standard human Ig include tenderness, erythema and stiffness of local muscles, which may persist for several hours. Mild fever or malaise may occasionally occur. Less common side effects following receipt of standard human Ig include flushing, headache, chills and nausea. Urticaria, angioedema and anaphylactic reactions may occur rarely. Botulism antitoxin (BAtx, equine) and botulism immune globulin (BIG-IV, human) Botulism antitoxin or botulism immune globulin is used therapeutically in people with established or suspected botulism . Prophylactically in asymptomatic people strongly suspected of having eaten food contaminated with the botulism toxin. Varicella zoster immune globulin (VarIg) Varicella zoster immune globulin (VariZIG™) is a freeze-dried preparation of varicella zoster Ig prepared from the pooled human plasma of screened donors with high titres of antibodies to varicella zoster virus. VarIg is recommended for the prevention or reduction in severity of infection within 4 days (96 hours) of the most recent exposure to the varicella zoster virus. 1. The exposed person is susceptible to varicella (except for recipients of HSCT). 2. There has been a significant exposure to a person with varicella or herpes zoster (HZ). 3. The exposed person is at increased risk of severe varicella including: Pregnant women Newborn infants of mothers who develop varicella during the 5 days before to 48 hours after delivery Selected neonates in intensive care settings Immunocompromised persons (including those with HIV with CD4 cell count < 200 x 106/L or CD4 percentage < 15%) Recipients of HSCT regardless of pre-transplant varicella immune status, history of varicella disease or vaccination, or positive serologic test results 4. Post-exposure immunization with univalent varicella vaccine is contraindicated. Hepatitis B post-exposure prophylaxis, recommendations for use of HBIg Post-exposure prophylaxis circumstance Infant born to a mother with acute or chronic hepatitis B infection Percutaneous or mucosal exposure to blood or body fluids potentially containing hepatitis B virus Recommendations •All infants born to infected mothers should be given an IM dose of 0.5 mL HBIg as soon as possible after birth (preferably within 12 hours) in addition to the first of a three dose series of HB vaccine (premature infants weighing less than 2,000 grams at birth require four doses of vaccine). The efficacy of HBIg decreases significantly after 48 hours, but HBIg may be given up to 7 days after birth. •HBIg should be given to susceptible individuals (based on their immunization and antibody status, and the infectious status, if known, of the source) within 48 hours after exposure1. Efficacy of HBIg decreases significantly after 48 hours, but HBIg may be given up to 7 days after exposure. •Dose of HBIg for older infants, children and adults is 0.06 mL/kg of body weight IM ARTIFICIALLY ACQUIRED ACTIVE IMMUNIZATION Artificially acquired active immunization Artificially acquired active immunity can be induced by a vaccine, a substance that contains antigen. A vaccine stimulates a primary response against the antigen without causing symptoms of the disease. VACCINATION It is the administration of vaccines or toxoids that stimulate the body immune system to produce antibodies and cellular immune responses that protect against the infectious agent. A vaccine stimulates a primary response against the antigen without causing symptoms of the disease. WHY WE NEED VACCINES For a few weeks after birth, babies have some protection from germs that cause diseases. This protection is passed from their mother through the placenta before birth. After a short period, this natural protection goes away. Vaccines help protect against many diseases that used to be much more common. Examples include tetanus, diphtheria, mumps, measles, pertussis (whooping cough), meningitis, and polio. Many of these infections can cause serious or life-threatening illnesses and may lead to lifelong health problems. Because of vaccines, many of these illnesses are now rare. TYPES OF VACCINES LIVE, ATTENUATED VACCINES INACTIVATED VACCINES SUBUNIT VACCINES TOXOID VACCINES LIVE VACCINES RECOMBINANT VECTOR VACCINES DNA VACCINES LIVE, ATTENUATED VACCINES Live, attenuated vaccines are composed of micro-organisms that have been cultivated under conditions which disable their ability to induce disease. These responses are more durable and do not generally require booster shots. Examples include yellow fever, measles, rubella, and mumps Examples of Live, attenuated bacteria vaccines include BCG and typhoid oral vaccines. INACTIVATED VACCINES Inactivated vaccines are composed of microorganisms that have been killed with chemicals and/or heat and are no longer infectious. Examples are vaccines against flu, cholera, plague, and hepatitis A. Most vaccines of this type are likely to require booster shots. SUBUNIT VACCINES Subunit vaccines are composed of small fragments of disease causing organisms. A characteristic example is the subunit vaccine against Hepatitis B virus. TOXOID VACCINES Are inactivated toxic compounds from microorganisms in cases where these (rather than the micro-organism itself) cause illness, used prior to an encounter with the toxin of the micro-organism. Examples of toxoid-based vaccines include tetanus and diphtheria. Surface antigen (recombinant) vaccines. It is prepared by cloning HBsAg gene in yeast cells where it is expressed. HBsAg produced is then used for vaccine preparations. Their efficacy and safety also appear to be high. Conjugate vaccine Conjugate vaccines are somewhat similar to recombinant vaccines: they’re made using a combination of two different components. Conjugate vaccines are made using pieces from the coats of bacteria. These coats are chemically linked to a carrier protein, and the combination is used as a vaccine. Conjugate vaccines are used to create a more powerful, combined immune response: typically the “piece” of bacteria being presented would not generate a strong immune response on its own, while the carrier protein would. The piece of bacteria can’t cause illness, but combined with a carrier protein, it can generate immunity against future infection. Two important vaccines in child health care are the pneumococcal conjugate vaccine (PCV) and the meningococcal conjugate vaccine (MCV). PCV is routinely used in many countries to prevent bacterial meningitis, pneumonia, and related infections , it does not protect immunized children against all pneumococcal bacteria. It only protects against seven of these. The meningococcal vaccine : to protect children against a different strain of meningitis, which is caused by a bacterium called meningococcus. Live vaccines Live vaccines are made from live infectious agents without any amendment. The only live vaccine is “Variola” small pox vaccine, made of live vaccinia cow-pox virus (not variola virus) which is not pathogenic but antigenic, giving cross immunity for variola. Vaccine type Vaccines of this type on U.S. Recommended Childhood (ages 0-6) Immunization Schedule Live, attenuated Measles, mumps, rubella (MMR combined vaccine) Varicella (chickenpox) Influenza (nasal spray) Rotavirus Inactivated/Killed Polio (IPV) Hepatitis A Toxoid (inactivated toxin) Diphtheria, tetanus (part of DTaP combined immunization) Subunit/conjugate Hepatitis B Influenza (injection) Haemophilus influenza type b (Hib) Pertussis (part of DTaP combined immunization) Pneumococcal Meningococcal Vaccine type Other available vaccines Live, attenuated Zoster (shingles) Yellow fever Inactivated/Killed Rabies Subunit/conjugate Human papillomavirus (HPV) Scheme of immunization Primary vaccination One dose vaccines (BCG, variola, measles, mumps, rubella, yellow fever) Multiple dose vaccines (polio, DPT, hepatitis B) Booster vaccination an extra administration of a vaccine after an earlier (prime) dose. After initial immunization. a booster injection or booster dose is a re-exposure to the immunizing antigen cell. It is intended to increase immunity against that antigen back to protective levels after it has been shown to have decreased or after a specified period. i.e To maintain immunity level after it declines after some time has elapsed (DT, MMR) Recent schedule for Vaccination of Newborns in Saudi Arabia. Starting 2008. Age at visit At birth 2 - Months 4 - Months 6 - Months 9 - Months 12 - Months 18 - Months Vaccines • • • • BCG HepB IPV [ DTP, HepB , Hib ] • • • • • OPV [ DTP, HepB, Hib ] OPV, [ DTP, HepB , Hib ] Measles ( mono ) • OPV ,MMR • Varicella • OPV • DTP, Hib • Hepatitis (A) 24 - Months • Hepatitis (A) 4 - 6 Years • OPV,DTP, MMR, Varicella. ROUTES OF ADMINISTRATION A vaccine administration may be oral, by injection (intramuscular, intradermal, subcutaneous), by puncture, transdermal or intranasal. Several recent clinical trials have aimed to deliver the vaccines via mucosal surfaces to be up-taken by the common mucosal immunity system, thus avoiding the need for injections. Certain available vaccines and their routes of administration. Vaccine Type BCG Live attenuated Bacteria DTP D&T = Toxoids Route Intradermal (preferred) Intramuscular P = inactivated bacteria Hepatitis B(HBV) Subunit , recombinant Intramuscular Haemophilus Influenza b (Hib) Polysaccharide Intramuscular MMR Live attenuated viruses BCG = DPT = MMR = OPV = Subcutaneous Bacillus Calmette – Guerin vaccine (tuberculosis). Diphtheria, pertussis and tetanus vaccine. Live measles, mumps and rubella viruses in a combined vaccine. Oral Poliovirus vaccines containing attenuated poliovirus types 1,2 and 3. ADVERSE REACTIONS OF SOME VACCINES Local reaction: Irritation ,redness and swelling. Systemic reaction: Fever ,rash and allergy. SPECIFIC REACTIONS: MEASLES VACCINE: Fever (usually the nineth day), transient rash and arthralgia. Rubell vaccine: Fever ,transient rash, transient lymphadenopathy and arthralgia. Mumps vaccine: Mild parotid enlargement. BCG VACCINATION: -persistent ulcer ,axillary lymhadenitis ,cold abcess and sinus formation. - generalized tuberculosis in immunocompromised. PERTUSIS VACCINE: - redness , pain and swelling locally , fever drowsiness and somnolence. - convulsions , encephalopathy and shock. These side effects are extremely rare and non-existent with acellular pertussis vaccine. CONTRAINDICATIONS TO VACCINATION Live attenuated vaccine like BCG , OPV ,MMR and varicella should not be given to immunocompromised infants and children or to their contacts. CONTRAINDICATIONS TO PERTUSSIS VACCINE 1. Encephalopathy within 7 days of previous vaccination. 2. Convulsions or history of convulsions. 3. Persistent unusual cry. 4. Fever above 40.5 c 5. Shock or somnolence. 6. Allergy The Cold Chain The "cold chain" is a system of storage and transport of vaccines at low temperature from the manufacturer to the actual vaccination site. The cold chain system is necessary because vaccine failure may occur due to failure to store and transport under strict temperature controls. The Cold Chain Equipment Cold chain equipment consists of the following: (a) Walk in cold rooms: They are located at regional level, meant to store vaccines up to 3 months and serve districts. (b) Deep freezers (300 ltr) and Ice lined Refrigerators: supplied to all districts and the WIC locations to store vaccines. Deep freezers are used for making ice packs and to store OPV and measles vaccines. (c) Small deep freezers and ILR (140 ltr) : One set is provided to PHCs, and Family Planning Centers (d) Cold boxes: Cold boxes are supplied to all peripheral centers. These are used mainly for transportation of the vaccines. (e) Vaccine carriers: Vaccine carriers are used to carry small quantities of vaccines (16-20 vials) for the out of reach sessions. 4 fully frozen ice packs are used for lining the sides, and vials of DPT, DT, TT and diluents should not be placed in direct contact with frozen ice packs. The carriers should be closed tightly. (f) Ice packs: The ice packs contain water and no salt should be added to it. Among the vaccines, polio is the most sensitive to heat, requiring storage at minus 20 degree C. Vaccines which must be stored in the freezer compartment are : polio and measles. Vaccines which must be stored in the cold part but never allowed to freeze are : typhoid, DPT, tetanus toxoid, DT, BCG and diluents Less commonly used vaccines MENINGEOCOCCAL VACCINE There are meningococcal vaccines that help provide protection against five types (serogroups) of meningococcal disease. Meningococcal vaccines cannot prevent all cases of the disease, but they do protect many people who might become sick if they didn't get vaccinated. FOR CHILDREN Meningococcal conjugate vaccine (MenACWY or Hib-MenCY-TT) is recommended for children 2 months through 10 years of age who are at increased risk for meningococcal disease as: -Certain medical conditions. -Traveling to a country with high rates of meningococcal disease. -An outbreak in their community. Booster doses may be recommended child remains at increased risk. FOR PRETEENS/TEENS Meningococcal conjugate vaccine (MenACWY) is routinely recommended for all 11 through 18 year olds. The first dose should be given at 11-12 years of age and a booster dose at 16 years of age ROTAVIRUS VACCINE Rotavirus is a virus that causes diarrhea, mostly in babies and young children. The diarrhea can be severe, and lead to dehydration. Two brands of rotavirus vaccine are available. 2 or 3 doses, depending on which vaccine is used. Doses are recommended at these ages: • First Dose: 2 months of age • Second Dose: 4 months of age • Third Dose: 6 months of age (if needed) N.B. must get the first dose of rotavirus vaccine before 15 weeks of age, and the last by age 8 months. Rotavirus vaccine may safely be given at the same time as other vaccines. Almost all babies who get rotavirus vaccine will be protected from severe rotavirus diarrhea. And most of these babies will not get rotavirus diarrhea at all. The vaccine will not prevent diarrhea or vomiting caused by other germs. There is a small risk of intussusception from rotavirus vaccination, usually within a week after the 1st or 2nd vaccine dose CONTRAINDICATIONS TO ROTAVIRUS: A life-threatening allergic reaction to a dose of rotavirus vaccine should not get another dose. A severe allergy to any part of rotavirus vaccine should not get the vaccine. Babies with “severe combined immunodeficiency” (SCID) should not get rotavirus vaccine. Intussusception Mildly ill can get the vaccine. Are moderately or severely ill should wait until they recover(includes babies with moderate or severe diarrhea or vomiting. If immune system is weakened because of: • HIV/AIDS, or any other disease that affects the immune system • Treatment with drugs such as steroids • Cancer, or cancer treatment with x-rays or drugs INFLUENZA VACCINE Inactivated Egg grown Sub-unit vaccine for children INDICATIONS: -Children who have chronic pulmonary or cardiovascular disorders, including asthma -Children who have required regular medical follow-up or hospitalization during the last year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications) - Children and teenagers (6 mths to 18 yrs) receiving long-term aspirin therapy - might be at risk for developing Reye syndrome after influenza -Children from 0-23 mths are at increased risk for hospitalization from influenza, vaccination is encouraged for their household contacts and out-of-home caretakers, particularly for contacts of children aged 0–5 months because influenza vaccines have not been approved for use among children aged <6 months. RABIES VACCINE Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. Rabies vaccine is given to people at high risk of rabies to protect them if they are exposed. It can also prevent the disease if it is given to a person after they have been exposed. Rabies vaccine is made from killed rabies virus. It cannot cause rabies. PREVENTIVE VACCINATION (NO EXPOSURE) International travelers who are likely to come in contact with animals in parts of the world where rabies is common. The pre-exposure schedule for rabies vaccination is three doses, given at the following times: Dose 1: As appropriate Dose 2: 7 days after Dose 1 Dose 3: 21 days or 28 days after Dose 1 VACCINATION AFTER AN EXPOSURE Anyone who has been bitten by an animal, or who otherwise may have been exposed to rabies, should clean the wound first. A person who is exposed and has never been vaccinated against rabies should get four doses of rabies vaccine one dose right away, and additional doses on the third, seventh and fourteenth days. They should also get another shot called Rabies Immune Globulin at the same time as the first dose. A person who has been previously vaccinated should get two doses of rabies vaccine - one right away and another on the third day. Rabies Immune Globulin is not needed. THANK YOU