Presentation on theme: "Moderator – Prof. A. M. Mehendale"— Presentation transcript:
1Moderator – Prof. A. M. Mehendale Newer VaccinesModerator – Prof. A. M. Mehendale
2Framework: List of newer vaccines: Introduction Immunization Vaccine Development of vaccinesNeed for new vaccinesRegulation & testing of vaccinesList of newer vaccines:HPVMalariaPandemic -influenza A (H1N1)RotavirusCholera vaccineMeningococcalJapanese encephalitisYellow feverHepatitis A&BVaricellaHaemophilus Influenza BPneumococcalHIV vaccine
3Introduction: Immunization: Immunization is the process whereby a person is made immune or resistant to an infectious diseaseImmunization is a proven tool for controlling and eliminating life-threatening infectious diseasesIt is one of the most cost-effective health investments, with proven strategies that make it accessible to even the most hard-to-reach and vulnerable populationsIt has clearly defined target groups, can be delivered effectively through outreach activities and does not require any major lifestyle changetypically by the administration of a vaccine
4Vaccine Vaccine may contain It is a suspension of attenuated or killed microorganisms, or of antigenic proteins derived from them, administered for prevention or amelioration of infectious diseases.Helps stimulate the body's own immune system to produce antibodies to fight particular disease.Vaccine may containlive but avirulent organism, orkilled microorganism , orpurified macromolecular component of a microorganism ora plasmid that contains a complementary DNA encoding a microbial antigens.Antibodies that are produced to protect against future infection.
5VaccineLive attenuated vaccines: BCG, typhoid, oral polio, plague, yellow fever, measles, mumps, rubellaInactiavted/ Killedvaccines: Typhoid, cholera, rabies, polio(salk)Toxoids: Diptheria &tetanusImmunoglobulins: Hepatitis A, rabies,Immunobiological substanceSpecific protectionMost powerful & cost effective disease prevention toolPrimarily for Prevention of infectious diseases now for non-infectious diseases (e.g. fertility, autoimmune disease & cancer)Immunizing agents:
6Immune ResponseVaccination stimulates the immune system with a particular agent (e.g. bacterium, virus, toxin) causing it to develop antibody against it and produces immunological memory.Anything that stimulates an immune response, whether naturally or via vaccination is called an antigen.Vaccinated individuals produce a much stronger immune response if they encounter the agent again and will have a much lower chance of developing disease.Types of immune responses:Cell-mediatedspecific cells called cytotoxic T cells attack cells in the body that have become infected, andHumoralbody develops antibodies that neutralize and help eliminate antigens in the blood, on epithelial surfaces and in tissues fluid
7The Development Of Vaccines First generation—whole - organism vaccines Inactivated/Killed,-live attenuatedSecond generationsubunit vaccine,recombinant antigen Vaccine,,synthetic peptide vaccinesThird generation----DNA vaccineOther - Anti-idiotypic vaccineDendritic cell vaccine
9Need For New VaccinesPathogens that have circulated for long but existence ignored : HepB, Pneumococcal diseases, Rota - virus Old pathogens change geographical habitat and are introduced into newer areas : Chikungunya, West NileNew pathogens have emerged : SARS, Avian FluPathogens thought to be controlled have re-emerged : M tuberculosis
10Framework For Decision Making On Introducing New Vaccines Is the disease a public health problem?Is immunization the best control strategy for this disease?Is the immunization programme working well enough to add a vaccine?What would be the net impact of the vaccine?Is the vaccine a good investment?How will be the vaccine funded?How will the addition of the new vaccine be implemented?
11An ideal Vaccine Should have … Good Immune responseBoth cell mediated immunity and antibody responseProvide long lived immunityPreferably single doseSafetyDanger of reversion to virulence or severe disease in immuno-compromisedStabilityOrganisms in the vaccine must remain viable in order to infect and replicate in the hostVaccine preparations should be less sensitive to adverse storage conditionsExpenseCheap to prepare
12Regulation & testing of vaccines Phase I: is a human trial & focuses on safety involving small groups.Phase II: Involves moderate-sized "target" populations to determine both safety and the stimulation of immune responsePhase III: extensive testing performed on large target populations to establish whether a vaccine actually prevents a disease as intended (efficacy)
13General WHO position on new vaccines Vaccines for large-scale public health use should:meet the quality requirements as defined in the Global Programme on Vaccines policy statement on vaccine qualitybe safe and have a significant impact against the actual disease in all target populationsif intended for infants or young children, be easily adapted to schedules and timing of the national childhood immunization programmesnot interfere significantly with the immune response to other vaccines given simultaneouslybe formulated to meet common technical limitations, e.g. in terms of refrigeration and storage capacitybe appropriately priced for different markets.
15Human papilloma virus vaccine Quadrivalent vaccine (2006)VLPs for 6,11,16,18Bivalent vaccine (2007)VLPs for 16,18IndicationsYoung adolescent girls as young as 9 years & prevention of anogenital warts in females &malesYoung adolescent girls as young as 10 yearsDose &route0.5ml imSchedule0, 2 & 6 months. minimum 4 wks interval bet 1st & 2nd &12 wks bet 2nd&3rd0, 1 & 6 months.2nd dose bet 1 and 2 ½ months after the 1st dose.Side effectsMild and transient local reactions at the site of injection i.e erythema, pain or swellingsameContraindicationssevere allergic reactions to previous dose, severe acute illness, pregnant femalesProtection70% against cervical cancers
16Malaria vaccine: Mosquirix (RTS,S): Recombinant protein-based virus-like particle malaria antigens on Hepatitis B particle30% efficacy against clinical malaria, 57% efficacy against severe malariaRTS,S induces production of Ab’s and T cells that interfere with the ability of the malaria parasite to infect humansBased on normal timelines that could see Mosquirix reaching the market in 2012.Mosquirix vaccine is currently in third - stage clinical trials, GlaxoSmithKline reported.Mosquirix is being tested in some 16,000 children and infants at 11 trial sites in seven countries.(circumsporozoite protein
17Rotavirus vaccine: Vaccine Rotarix™ vaccine(The monovalent human ) 2007RotaTeq™ vaccine(pentavalent bovine–human) 05-06Indications/AgeInfants 2 and 4 months of age.Infants2, 4 and 6 months of ageRouteOrally 2 dosesOrally 3 dosesSchedule1st dose at 6wks&2nd at 16wks.Interval bet 2doses at least 4wks1st dose at 6-12wks and 2nd,3rd doses at an interval of 4-10wksSide effectsMild & transient symptoms of gastrointestinal or respiratory tractContra indicationsHypersensitivity, history of intussusception or intestinal malformations AGE febrile illnessHypersensitivity, history of intussusception or intestinal malformations AGE, febrile ill
18Cholera vaccine: Vaccine Killed whole-cell vaccine DUKORAL, 2004 (cholerae 01 in combination withrecombinant B-sub unit of cholera toxin)Indications/AgeTravellers , Aid workers assisting in disaster relief or refugee camps, travelling to remote regions with limited access to medical care, risk travellers with underlying gastrointestinal illness or immune suppression >2yrs of ageDose & route2doses orallySchedule1wk apart3 weeks before departureSide effectsNoneContraindicationsHypersensitivity to previous doseProtection(85–90%) protection for 6 months after the second dose. Protection declines rapidly in young children after 6 months, but remains as high as 62% in adult vaccine recipients.Dukoral is a monovalentvaccine based on formalin and heat-killed wholecells (WC) of V. cholerae O1
19Cholera vaccine: Vaccine Shanchol and mORCVAX The closely related bivalent oral choleravaccines based on serogroups O1 and O139.Indications/AgeAbove 1 years of ageDose & routeOrally, 2 dosesSchedule2 liquid doses 14 days apartProtectionprotective efficacy of the vaccine for all ages after 2 doses is 66%licensed in 2009 as mORCVAX in Viet Nam and as Shancholin India; mORCVAX is currently intended for domesticuse in Viet Nam, whereas Shanchol will be producedfor Indian and international markets.Dukoral is a monovalentvaccine based on formalin and heat-killed wholecells (WC) of V. cholerae O1
20Meningococcal vaccine: Indications:Travellers to industrialized countries are exposed to the possibility of sporadic cases.Outbreaks of meningococcal C disease occur in schools, colleges, military barracks and other places where large numbers of adolescents and young adults congregate.Long-term travellers living in close contact with the indigenous population may be at greater risk of infection.Vaccines: - Polysaccharide vaccine- Conjugate vaccine
21Continuation……………Polysaccharide vaccines:bivalent (A and C) or tetravalent (A, C, Y and W-135)One dose, provides protection for 3–5 yearsVaccine should be given 2 weeks before departureChildren under 2 years of age are not protected by the vaccineTravellers should opt (A, C, Y, W-135) than the bivalent vaccineConjugate vaccine:Monovalent serogroup C conjugate vaccineslicensed for use since 1999incorporated in national vaccination programmes in an increasing number of countries.prolonged duration of protection in infants who are vaccinated at 2, 3 and 4 months of age.
22Japanese Encephalitis Indications:Vaccination is recommended for travellers with extensive outdoor exposure (camping, hiking, bicycle tours, outdoor occupational activities, in particular in areas where flooding irrigation is practiced)In rural areas of an endemic region during the transmission season.It is also recommended for expatriates living in endemic areas through a transmission season or longer.Two types of JE vaccine are widely availableinactivated mouse-brain-derived vaccine (IMB)cell-culture-derived live attenuated SA vaccine.
23(1) Inactivated mouse-brain-derived Dose: 0.5 or 1.0 ml for adults, 0.25 or 0.5 ml for children depending on ageSchedule: 3 doses given 0, 7 and 28days.If 2doses given preferably 4 weeks apart. Booster after 1 year and then 3-yearlyBefore departure : At least two doses(2) Cell-culture-derived live attenuated SA vaccineDose: Same, Single dose givenBooster: single booster dose given at an interval of about 1 yearBefore departure: one doseContraindications:Hypersensitivity to a previous dose of vaccinepregnancy and immuno-suppressionAdverse reactions:Occasional mild local or systemic reaction; occasionalsevere reaction with generalized urticaria,hypotension and collapseContraindications:Hypersensitivity to a previous dose of vaccine, pregnancy and immuno-suppressionAdverse reactions:Occasional mild local or systemic reaction; occasionalsevere reaction with generalized urticaria,hypotension and collapse
24Yellow Fever Type of vaccine Live, attenuated (17D viral strain) Number of dosesOne priming dose of 0.5 ml (s/c or im)Booster10-yearly (if re-certification is needed)ContraindicationsEgg allergy, immunodeficiency from medication, disease or symptomatic HIV infection, hypersensitivity to a previous dose, pregnancyAdverse reactionsRarely, encephalitis or hepatic failureBefore departureInternational certificate of vaccination becomes valid 10 days after vaccinationRecommendedAll travellers to areas with risk of yellow fever transmissionSpecial precautionsNot for infants under 9 months of age; restrictions in pregnancy
25Hepatitis BThree doses given the first two doses are usually given 1 month apart, with the third dose 1–12 months laterProtection for at least 15 years and probably for life. Boosters are not recommended.Because of the prolonged incubation period of hepatitis B, some protection will be afforded to most travellers following the second dose given before travel. The final dose should always be given upon return.A rapid schedule of administration of Monovalent hepatitis B vaccine has been given day 0, 1 month 2 months. An additional dose is given 6-12 months after the first dose.A very rapid schedule of administration of hepatitis B vaccine has been proposed day 0, 7 , 21 days. An additional dose is given at 12 months.
26Hepatitis BA combination vaccine that provides protection against both hepatitis A and hepatitis B should be considered for travellers potentially exposed to both organismsThis inactivated vaccine is administered as follows day 0,1 month, 6 months.A rapid schedule at day 0, 1 month and 2 months, with an additional dose at 12 monthsVery rapid schedule with administration at day 0, day 7 and day 21 with a booster dose at 12 months
27Hepatitis A Type of vaccine Inactivated (killed) Number of doses Two 0.5ml i.m. Second dose 6–24 months after the firstBoosterMay not be necessaryContraindicationsHypersensitivity to previous doseAdverse reactionsMild local reaction of short duration, mild systemic reactionBefore departureProtection 2–4 weeks after first doseRecommendedAll non-immune travellers to endemic areas
28VaricellaIn several industrialized countries, Varicella vaccines have been introduced into the childhood immunization programmes.Most adult travellers from temperate climates are immune (as a result of either natural disease or immunization).Adult travellers without a history of Varicella who travel from tropical countries to temperate climates may be at increased risk and should consider vaccination.Use at 9 months of age and older. optimal age for Varicella vaccination is 12–24 months.In Japan and several other countries 1 dose of the vaccine is considered sufficient regardless of age.In the United States 2 doses 4–8 weeks apart, are recommended for adolescents and adults.
29Varicella vaccine Side effects: Mild Varicella-like disease with rash within 4 weeks.ContraindicationsPregnancy (pregnancy should be avoided for 4 weeks following vaccination),Ongoing severe illnessAnaphylactic reactionsImmuno suppression.
30Haemophillus influenzae type b (Hib) Indications:Pneumonia, respiratory infection common in children < 2 yearsVaccineConjugate polysaccharide b vaccineSchedule:6,10,14 weeks booster at monthsDose:0.5 ml im ant.lat.aspect of thighContra-indictaions:Local pain, erythema, fever
31Influenza vaccine two vaccines are available: The inactivated killed Vaccine (2004)2 doses 4 weeks apart recommended. Immunity lasts for 3-6 months so annual revaccination recommended.Live attenuated influenza vaccine (2003)Given only to healthy persons 5 to 49 yrs of age who are not in contact with severely immuno-suppressed personsIntra nasally annually to optimize protectionThe inactivated killed VaccineLive attenuated influenza vaccineBoth vaccines includes Two type A strains (eg H3N2 and H1N1) & One type B strain
32Pandemic influenza A (H1N1) vaccines: Pandemic influenza A (H1N1) vaccines are available for use since September 2009Most of these vaccines are produced using chicken eggs, while a few manufacturers are using cell culture technology for vaccine productionHealth care workers worldwide should be immunized as a first priorityA maximum of 4.9 billion doses potentially could be produced in 12 months.
33Pneumococcal vaccine Pneumococcal conjugated vaccine (PCV7): 2000 -infants and toddlers (6 weeks to 9 years)Pneumococcal polysaccharide vaccine (PV23):widely licensed for use in adults and children aged >2 years who have certain underlying medical conditions.(Sickle cell disease, damaged spleen / spleenec-tomised , AIDS, disease affecting immune system, diabetes, liver ds. chronic lung & heart disease, who is on immunosuppresive therapy).Dose: 0.5 mlSchedule s/c or i.m<6 months 3 doses (6, 10, 14wks)7-11 months- 2 doses & booster after 1yr12-23 months-2 doses>24mnths single dose
34Pneumococcal vaccineSide-effects: Redness, tenderness, swelling ,fever, loss of appetite, irritability, drowsinessContraindications: Allergic reaction to 1st dose, Severely illEfficacy of upto 57 % for cases of otitis media by serotypes represented in the vaccine is reported.
35HIV VaccineThe availability of safe, highly effective and accessible HIV vaccinePhase III trial for evaluating the efficacy of an envelope GP120 candidate vaccine and GP160 vaccine are conducted.