Newer Vaccines

Presenter: Dr K. SushmaModerator:Dr Sanam Anwar

Framework:

• Introduction• Immunization• Vaccine• Regulation & testing of vaccines• Type of vaccines:

• HPV• Malaria• Pandemic -influenza

A (H1N1)• Rotavirus• Cholera vaccine• Meningococcal

• Japanese encephalitis• Yellow fever• Hepatitis A&B• Varicella• Haemophilus

Influenza B• Pneumococcal

Introduction:Immunization:– Immunization is the process whereby a person is made

immune or resistant to an infectious disease, typically by the administration of a vaccine

– Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to avert over 2 million deaths each year

– 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, it can be delivered effectively through outreach activities, and vaccination does not require any major lifestyle change

Vaccine• 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:Vaccines:• Live attenuated vaccines: BCG, typhoid, oral polio plague,

yellow fever,measles,mumps,rubella• Inactiavted/

Killedvaccines:Typhoid,cholera,pertussis,rabies,polio(salk)• Toxoids:Diptheria &tetanusImmunoglobulins:• Hepatitis A,measles,rabies,diptheria,tetanus

Regulation & testing of vaccines• Phase I: This is a human trial and it focuses on safety

involving small groups.

• Phase II: Involves moderate-sized "target" populations (persons close to the age and other characteristics for whom the vaccine is intended) to determine both safety and the stimulation of immune response

• Phase III: In this phase extensive testing performed on large target populations to establish whether a vaccine actually prevents a disease as intended (efficacy)

Human papilloma virus vaccine

Vaccine Quadrivalent vaccine(2006) Bivalent vaccine(2007)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 0.5ml im

Schedule 0,2&6months. 4 wks interval bet 1st & 2nd &12 wks bet 2nd&3rd

0,1&6months.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

Mild and transient local reactions at the site of injection i.e erythema, pain or swelling

Contraindications

severe allergic reactions to previous dose, severe acute illness, pregnant females

severe allergic reactions to previous dose, severe acute illness, pregnant females

Protection 70% against cervical cancers 70% against cervical cancers

Malaria vaccine:

Mosquirix (RTS,S):– Recombinant protein-based virus-like particle malaria

antigens (circumsporozoite protein )on Hepatitis B particle– 30% efficacy against clinical malaria,57% efficacy against

severe malaria– RTS,S induces production of antibodies 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 final-stage clinical trials, GlaxoSmithKline reported.

– Mosquirix will be tested in  some 16,000 children and infants at 11 trial sites in seven countries.

Pandemic influenza A (H1N1) vaccines:• Pandemic influenza A (H1N1) vaccines be available for use as

early as September 2009• Most of these vaccines will be 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.

Rotavirus vaccine:Vaccine Rotarix™ vaccine(The

monovalent human )RotaTeq™ vaccine(The pentavalent bovine–human)

Indications/Age Infants 2 and 4 months of age. Infants2, 4 and 6 months of age

Dose &route Orally 2doses 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

Mild&transient symptoms of gastrointestinal or respiratory tract

Contraindications

Hypersensitivity, history of intussusception or intestinal malformations acute gastroenteritis orserious febrilei llness.

Hypersensitivity, history of intussusception or intestinal malformations acute gastroenteritis orserious febrile illness

Cholera vaccine:Vaccine Killed whole-cell vaccine(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 orallySchedule 1wk apart

3 weeks before departure

Side effects NoneContraindications 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 ashigh as 62% in adult vaccine recipients.

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.

• Travellers to the sub-Saharan meningitis belt may be exposed to outbreaks of serogroup A disease & high incidence rates are seen during the dry season (December–June).

• Long-term travellers living in close contact withthe indigenous population may be at greater risk of infection.

• Pilgrims to Mecca are at risk.

Continuation……………• Polysaccharide vaccines:– meningococcal polysaccharide vaccines are either bivalent(A

and C) or tetravalent (A, C, Y and W-135)– Only one dose which provides protection for3–5 years – Vaccine should not given when there is serious adverse

reaction to previous dose– Occasional mild local reactions; rarely, fever– Vaccine should be given 2 weeks before departure– Children under 2 years of age are not protected by thevaccine– Travellers should opt (A, C, Y,W-135) than the bivalent

vaccine because of the additional protection against groups Y and W-135

– No protection against group B meningococci, whichare the leading cause of endemic meningococcal disease in some countries

Conjugate vaccine:• Monovalent serogroup C conjugate vaccines were fi rst

licensed for use in 1999 are now incorporated in national vaccination programmes in an increasing number of countries.

• Increased immunogenicity among infants and prolonged duration of protection in infants who are vaccinated at 2, 3 and 4 months of age.

• Tetravalent conjugate vaccine (A, C, Y, W-135) has been licensed in a limited number of countries.

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 practised)

– 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 14-14-2 vaccine.

Inactivated mouse-brain-derived

Dose:0.5 or 1.0 ml for adults, 0.25 or 0.5 ml for children depending on the vaccines

Schedule:3 doses given 0, 7 and 28days.If 2doses given preferably 4 weeks apart.Booster after 1 year and then 3-yearly

Contraindications:• Hypersensitivity to a previous dose of vaccine, pregnancy• and immunosuppressionAdverse reactions:• Occasional mild local or systemic reaction; occasional• severe reaction with generalized urticaria, hypotension• and collapseBefore departure:At least two doses

Cell-culture-derived live attenuated SA 14-14-2 vaccineDose:0.5 or 1.0 mlfor adults, 0.25 or 0.5 ml for children depending on

thevaccines.Single dose givenBooster:• single booster dose given at an interval of about 1 year

Contraindictaions:• Hypersensitivity to a previous dose of vaccine, pregnancy• and immuno suppressionAdverse effects:• Occasional mild local or systemic reaction; occasional• severe reaction with generalized urticaria, hypotension• and collapseBefore departure:• one dose

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 previousDose, pregnancy

Adverse reactions Rarely, encephalitis or hepatic failure

Before departure International certificate of vaccination becomes valid10 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 inpregnancy

Hepatitis B• Three doses given the fi rst 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 administrationof hepatitis B vaccine has been proposed day 0, 7 , 21 days. An additional dose is given at 12 months.

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

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

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 States2 doses4–8 weeks apart, are recommended for adolescents and adults.

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.

Haemophilus 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 12-15 months

Dose:• 0.5 ml im ant.lat.aspectof thigh

Contrindictaions:• Local pain,erythema,fever

Influenza vaccine:• There are 2 influenza viruses, types A and B. – Type A :subtypes based on two surface antigens

Hemagglutinin (H) and Neuraminidase (N). eg H1N1– Influenza type B is not categorized into subtypes.

• There are two vaccines available:– The inactivated killed Vaccine– Live attenuated influenza vaccine– Both vaccines includes Two type A strains (eg H3N2 and

H1N1) & One type B strain • The inactivated killed Vaccine– 2 doses 4 weeks apart recommended. Immunity lasts for 3-

6 months so annual revaccination recommended.• Live attenuated influenza vaccine– 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

Pneumococcal vaccine:• Pneumococcal conjugated vaccine(PCV7):

-infants and toddlers(6 weeks to 9 years)• Pneumococcal polysaccharide vaccine(PV23): – This vaccine is widely licensed for use in adults and

children aged >2 years who have certain underlying medical conditions.( Sickle cell disease, damaged spleen/spleenectomised, AIDS, disease affecting immune system ,diabetes, liver ds. chronic lung ds, chronic 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

Pneumococcal vaccine:• Side-effects: Redness, tenderness, swelling ,fever, loss of

appetite, irritability, drowsiness • Contraindications: Allergic reaction to 1st dose, Severely ill

References:• WHO textbook International travel and health

January 2009• www.who.int• Weekly Epidemiological Records