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Moderator – Prof. A. M. Mehendale

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1 Moderator – Prof. A. M. Mehendale
Newer Vaccines Moderator – Prof. A. M. Mehendale

2 Framework: List of newer vaccines: Introduction Immunization Vaccine
Development of vaccines Need for new vaccines Regulation & testing of vaccines List of newer vaccines: HPV Malaria Pandemic -influenza A (H1N1) Rotavirus Cholera vaccine Meningococcal Japanese encephalitis Yellow fever Hepatitis A&B Varicella Haemophilus Influenza B Pneumococcal HIV vaccine

3 Introduction: Immunization:
Immunization is the process whereby a person is made immune or resistant to an infectious disease Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases It 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 populations It has clearly defined target groups, can be delivered effectively through outreach activities and does not require any major lifestyle change typically by the administration of a vaccine

4 Vaccine 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 contain live but avirulent organism, or killed microorganism , or purified macromolecular component of a microorganism or a plasmid that contains a complementary DNA encoding a microbial antigens. Antibodies that are produced to protect against future infection.

5 Vaccine Live attenuated vaccines: BCG, typhoid, oral polio, plague, yellow fever, measles, mumps, rubella Inactiavted/ Killedvaccines: Typhoid, cholera, rabies, polio(salk) Toxoids: Diptheria &tetanus Immunoglobulins: Hepatitis A, rabies, Immunobiological substance Specific protection Most powerful & cost effective disease prevention tool Primarily for Prevention of infectious diseases now for non-infectious diseases (e.g. fertility, autoimmune disease & cancer) Immunizing agents:

6 Immune Response Vaccination 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-mediated specific cells called cytotoxic T cells attack cells in the body that have become infected, and Humoral body develops antibodies that neutralize and help eliminate antigens in the blood, on epithelial surfaces and in tissues fluid

7 The Development Of Vaccines
First generation—whole - organism vaccines Inactivated/Killed, -live attenuated Second generation subunit vaccine, recombinant antigen Vaccine,, synthetic peptide vaccines Third generation----DNA vaccine Other - Anti-idiotypic vaccine Dendritic cell vaccine

8 Milestones In Vaccines Development

9 Need For New Vaccines Pathogens 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 Nile New pathogens have emerged : SARS, Avian Flu Pathogens thought to be controlled have re-emerged : M tuberculosis

10 Framework 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?

11 An ideal Vaccine Should have …
Good Immune response Both cell mediated immunity and antibody response Provide long lived immunity Preferably single dose Safety Danger of reversion to virulence or severe disease in immuno-compromised Stability Organisms in the vaccine must remain viable in order to infect and replicate in the host Vaccine preparations should be less sensitive to adverse storage conditions Expense Cheap to prepare

12 Regulation & 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 response Phase III: extensive testing performed on large target populations to establish whether a vaccine actually prevents a disease as intended (efficacy)

13 General 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 quality be safe and have a significant impact against the actual disease in all target populations if intended for infants or young children, be easily adapted to schedules and timing of the national childhood immunization programmes not interfere significantly with the immune response to other vaccines given simultaneously be formulated to meet common technical limitations, e.g. in terms of refrigeration and storage capacity be appropriately priced for different markets.

14 Newer Vaccines

15 Human papilloma virus vaccine
Quadrivalent vaccine (2006) VLPs for 6,11,16,18 Bivalent vaccine (2007) VLPs for 16,18 Indications Young adolescent girls as young as 9 years & prevention of anogenital warts in females &males Young adolescent girls as young as 10 years Dose &route 0.5ml im Schedule 0, 2 & 6 months. minimum 4 wks interval bet 1st & 2nd &12 wks bet 2nd&3rd 0, 1 & 6 months.2nd dose bet 1 and 2 ½ months after the 1st dose. Side effects Mild and transient local reactions at the site of injection i.e erythema, pain or swelling same Contraindications severe allergic reactions to previous dose, severe acute illness, pregnant females Protection 70% against cervical cancers

16 Malaria vaccine: Mosquirix (RTS,S):
Recombinant protein-based virus-like particle malaria antigens on Hepatitis B particle 30% efficacy against clinical malaria, 57% efficacy against severe malaria RTS,S induces production of Ab’s and T cells that interfere with the ability of the malaria parasite to infect humans Based 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

17 Rotavirus vaccine: Vaccine
Rotarix™ vaccine(The monovalent human ) 2007 RotaTeq™ vaccine(pentavalent bovine–human) 05-06 Indications/Age Infants 2 and 4 months of age. Infants2, 4 and 6 months of age Route Orally 2 doses Orally 3 doses Schedule 1st dose at 6wks&2nd at 16wks.Interval bet 2doses at least 4wks 1st dose at 6-12wks and 2nd,3rd doses at an interval of 4-10wks Side effects Mild & transient symptoms of gastrointestinal or respiratory tract Contra indications Hypersensitivity, history of intussusception or intestinal malformations AGE febrile illness Hypersensitivity, history of intussusception or intestinal malformations AGE, febrile ill

18 Cholera vaccine: Vaccine Killed whole-cell vaccine DUKORAL, 2004
(cholerae 01 in combination with recombinant B-sub unit of cholera toxin) Indications/Age Travellers , 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 age Dose & route 2doses orally Schedule 1wk apart 3 weeks before departure Side effects None Contraindications Hypersensitivity to previous dose Protection (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 monovalent vaccine based on formalin and heat-killed whole cells (WC) of V. cholerae O1

19 Cholera vaccine: Vaccine Shanchol and mORCVAX
The closely related bivalent oral cholera vaccines based on serogroups O1 and O139. Indications/Age Above 1 years of age Dose & route Orally, 2 doses Schedule 2 liquid doses 14 days apart Protection protective efficacy of the vaccine for all ages after 2 doses is 66% licensed in 2009 as mORCVAX in Viet Nam and as Shanchol in India; mORCVAX is currently intended for domestic use in Viet Nam, whereas Shanchol will be produced for Indian and international markets. Dukoral is a monovalent vaccine based on formalin and heat-killed whole cells (WC) of V. cholerae O1

20 Meningococcal 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

21 Continuation…………… Polysaccharide vaccines: bivalent (A and C) or tetravalent (A, C, Y and W-135) One dose, provides protection for 3–5 years Vaccine should be given 2 weeks before departure Children under 2 years of age are not protected by the vaccine Travellers should opt (A, C, Y, W-135) than the bivalent vaccine Conjugate vaccine: Monovalent serogroup C conjugate vaccines licensed for use since 1999 incorporated 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.

22 Japanese 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 available inactivated 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 age Schedule: 3 doses given 0, 7 and 28days.If 2doses given preferably 4 weeks apart. Booster after 1 year and then 3-yearly Before departure : At least two doses (2) Cell-culture-derived live attenuated SA vaccine Dose: Same, Single dose given Booster: single booster dose given at an interval of about 1 year Before departure: one dose Contraindications: Hypersensitivity to a previous dose of vaccine pregnancy and immuno-suppression Adverse reactions: Occasional mild local or systemic reaction; occasional severe reaction with generalized urticaria, hypotension and collapse Contraindications: Hypersensitivity to a previous dose of vaccine, pregnancy and immuno-suppression Adverse reactions: Occasional mild local or systemic reaction; occasional severe reaction with generalized urticaria, hypotension and collapse

24 Yellow Fever Type of vaccine Live, attenuated (17D viral strain)
Number of doses One priming dose of 0.5 ml (s/c or im) Booster 10-yearly (if re-certification is needed) Contraindications Egg allergy, immunodeficiency from medication, disease or symptomatic HIV infection, hypersensitivity to a previous dose, pregnancy Adverse reactions Rarely, encephalitis or hepatic failure Before departure International certificate of vaccination becomes valid 10 days after vaccination Recommended All travellers to areas with risk of yellow fever transmission Special precautions Not for infants under 9 months of age; restrictions in pregnancy

25 Hepatitis B Three doses given the first two doses are usually given 1 month apart, with the third dose 1–12 months later Protection 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.

26 Hepatitis B A combination vaccine that provides protection against both hepatitis A and hepatitis B should be considered for travellers potentially exposed to both organisms This 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 months Very rapid schedule with administration at day 0, day 7 and day 21 with a booster dose at 12 months

27 Hepatitis A Type of vaccine Inactivated (killed) Number of doses
Two 0.5ml i.m. Second dose 6–24 months after the first Booster May not be necessary Contraindications Hypersensitivity to previous dose Adverse reactions Mild local reaction of short duration, mild systemic reaction Before departure Protection 2–4 weeks after first dose Recommended All non-immune travellers to endemic areas

28 Varicella In 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.

29 Varicella vaccine Side effects:
Mild Varicella-like disease with rash within 4 weeks. Contraindications Pregnancy (pregnancy should be avoided for 4 weeks following vaccination), Ongoing severe illness Anaphylactic reactions Immuno suppression.

30 Haemophillus influenzae type b (Hib)
Indications: Pneumonia, respiratory infection common in children < 2 years Vaccine Conjugate polysaccharide b vaccine Schedule: 6,10,14 weeks booster at months Dose: 0.5 ml im of thigh Contra-indictaions: Local pain, erythema, fever

31 Influenza 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 persons Intra nasally annually to optimize protection The inactivated killed Vaccine Live attenuated influenza vaccine Both vaccines includes Two type A strains (eg H3N2 and H1N1) & One type B strain

32 Pandemic influenza A (H1N1) vaccines:
Pandemic influenza A (H1N1) vaccines are available for use since September 2009 Most of these vaccines are produced using chicken eggs, while a few manufacturers are using cell culture technology for vaccine production Health care workers worldwide should be immunized as a first priority A maximum of 4.9 billion doses potentially could be produced in 12 months.

33 Pneumococcal 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 ml Schedule s/c or i.m <6 months 3 doses (6, 10, 14wks) 7-11 months- 2 doses & booster after 1yr 12-23 months-2 doses >24mnths single dose

34 Pneumococcal vaccine Side-effects: Redness, tenderness, swelling ,fever, loss of appetite, irritability, drowsiness Contraindications: Allergic reaction to 1st dose, Severely ill Efficacy of upto 57 % for cases of otitis media by serotypes represented in the vaccine is reported.

35 HIV Vaccine The availability of safe, highly effective and accessible HIV vaccine Phase III trial for evaluating the efficacy of an envelope GP120 candidate vaccine and GP160 vaccine are conducted.

36 Thank You!

37 References Weekly Epidemiological Records
Vaccines update, Arora, Textbook of Microbiology, 3rd Edn. New generation vaccines, levine & woodrow Vaccines , Plotkin

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