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Dr E O D ADDO-YOBO
MSc, DTCH MD, MWACP, FGCPS,
2010
Outline
Basic Principles of Immunisation & Terminology Routine EPI vaccines Other vaccines New vaccines General Issues:
What is Immunisation?
Immunisation:
The biological process of conferring protection (artificially) in a human host against infectious agents in the environment .
Vaccination:
The act or practice of inducing in a non-immune person a primary response such that on first contact with the corresponding pathogen, a rapid secondary (memory response) is mounted, leading to prevention of disease symptoms.
Vaccine:
suspension of attenuated or killed micro-organisms or fractions thereof (i.e. purified protein sub-units, polysaccharides, conjugated PSs, or split virions ) administered (orally, in, id, im, sc) to induce specific immunity and prevent infectious disease prophylactic (i.e; EPI vaccines & therapeutic vaccines - i.e. cancer vaccines in development)
pathogen (human)
toxins
vaccine
heighten immune response (humoral and cell mediated) to pathogens should have minimal adverse effects prevent/reduce severity of infectious diseases (effectiveness) be of assured quality and available for general use
Vaccine(s)
Substances, Cells, Tissues and Organs in different locations (central and peripheral) Complement each other in protecting the body Main organs include skin, spleen, thymus, and lymph nodes. Freely mobile cells from bone marrow, blood and lymphatics.
Important Definitions
Immune response
Development of resistance/immunity to a foreign substance eg. infectious agent. Can be humoral (Ab) or cell mediated (lymphoid) or both.
Immunity The properties of host that confer resistance to a specific infectious agent. (The ability of the body to protect itself against disease causing organisms) Can be natural or acquired.
Acquisition of Immunity
Natural acquisition of immunity: from infection with the microbe in nature, e.g. measles resulting in protection from future exposure (note notion of prior exposure) Artificial immunity: vaccine or immunoglobulin administration
Vaccine: organism or toxin, either killed or live but attenuated (organism) or inactivated (toxin). Live vaccines (BCG, polio, measles); killed vaccines (pertussis, polio), toxoids (tetanus, diphtheria), subunit (hep B).
Immunization process
Administration of vaccine: Potent immune response in a few weeks, several injections for some (DPT), some one shot (measles). Booster doses may be necessary (Hep. B).
Vaccines are safe, side effects (AEFI) rarer than complications of disease prevented. Vaccines are fragile (storage). AEFI: hypersensitivity, human errors (poor or absent training, or level).
IgG Response
IgM Response
60 3rd Time
1 yr.
10 yrs
Types of immunity
Non-specific (primary/innate):
Specific (adaptive):
Requires prior exposure, hallmarks (memory, specificity, recognition of self and non-self), antigen- antibody
Secondary, Acquired
ingredients
Potential
Also
Live attenuated:
Viruses (oral polio, measles, mumps, rubella, yellow fever), Bacteria (BCG, cholera)- long lasting immunity, very fragile (cold chain), mutation to pathogenicity
Killed vaccines:
Viruses (hep. A, Salk polio), bacteria (pertussis, cholera)intermediate immunity, several doses may be required
ROUTE OF ADMINISTRATION
Pneumococcal
Measles Rotavirus
28%
21% 16% 12% 8%
WHO/FCH/IVB/VAM, JUN04 (<5y, 2002 data)
4.
5. 6.
rota
Hib
Pertussis Tetanus
15%
7.
8. 9. 10.
Yellow Fever
Diphtheria Poliomyelitis
<1%
<0.5% <0.5%
Meningococcal <0.5%
Age
Birth 6 weeks 10 weeks 14 weeks 6 months 9 months 12 months BCG
Vaccines
OPV 0 OPV 1 OPV 2 OPV 3 Yellow fever DPT/HepB/Hib 1 DPT/HepB/Hib 2 DPT/HepB/Hib 3 Vit A Measles Vit A
Disease = Tuberculosis Organism: Mycobacterium tuberculosis or M. bovis. Non-sporing, rod-shaped, acid-fast bacillus (neither gram positive or gram negative)
Vaccine: Live attenuated, freeze-dried Storage 2oC - 8oC. Never frozen. Do not shake to mix. Use with 2 hours. Shelf life 12 - 18 months. Vaccine Efficacy: 0 80% for PTB; 75-86% for Miliary and TB meningitis Indications: People at risk - infants, health personnel, contacts with sputum +ve cases. If exposure suspected, tuberculin test first then immunise. With contact: tuberculin test, repeat after 6 months, if positive => seroconversion, hence chemoprophylaxis.
[Tuberculin ]
Both Mantoux and Heaf = Purified Protein Derivative (PPD).
PPD = heat treated products of growth and lysis of mycobacterium. Results read 48 - 96 hours later. Positive result = induration of 5 mm in dia. with 0.1 ml 1 in 1000 dil. (If less => negative)
POLIOMYELITIS
Organism: Polio virus type I, II, III. Inactivated at 55 oC for 30 minutes but this is inhibited by Mg++, milk, ice cream. Adults more prone to in-apparent paralytic infections.
Vaccine: Inactivated polio virus = Salk (1956) (IPV) Live attenuated vaccine = Sabin (1962) (OPV) OPV, eIPV (Enhanced potency Inactivated Polio Vaccine) Contain live strains of virus types I, II, III Establishes both local gut and blood immunity May be given at the same time with other inactivated or live vaccines EXCEPT typhoid.
Efficacy:
>90% in industrialised countries 72-98% in hot climates; lower protection against type III
Duration of immunity:
DIPHTHERIA:
Agent: Toxin producing Corynebacterium diphtheriae Vaccine = toxoid: Comes as liquid + adjuvant Tendency for lower antibody levels in adults due to less natural boosting. Efficacy: > 87% Duration of immunity: About 5 years. Longer in presence of natural boosting Schick Test: Used to test immunity after diphtheria immunisation. Test solution is the inactivated toxin. Done at least 3 months after immunisation. No reaction => test -ve => immune subject. Erythema lasting approx. 7 days => test +ve => nonimmune subject.
Diphtheria antitoxin:
IM, IV - to treat suspected cases. Not for prophylaxis because causes intense sensitisation.
TETANUS
Agent:
Toxin producing Clostridium tetani
Vaccine =Toxoid Children & Adults: 3 doses one month apart: Reinforce at 10 year intervals x2 doses is enough for life. Booster dose considered at time of injury.
Rationale for Tetanus Toxoid immunisation for mothers of child bearing age
PERTUSSIS
Organism:-
(also B. parapertussis B. bronchoseptica) Vaccine: - Killed Bordetella pertussis Caution: Hx of febrile convulsion: - Advise on prevention of fever and give.
99% typeable strains causing disease are type b. Diseases: Meningitis + septicaemia - 60% Epiglotitis - 15 % Septicaemia - 10% Arthritis, osteomyelitis, cellulitis, pneumonia, pericarditis - 15% Infection rare under 3 months old, rapidly rises in 1st year with peak at 10 - 11 months, then declines till the age of 4 years after which infection is uncommon. Vaccine: Capsular polysaccharide + protein (to enhance immunogenicity in children less than 1 year old. Capsular polysaccharide alone is not immunogenic in children less than 18 months).
HEPATITIS B
Supplied as liquid DPT-HepB in one vial and lyophilised Hib in a separate vial.
Lyophilised Hib can be stored at -20oC or refrigerated at +2 - +8 oC
Measles Vaccine:
Live attenuated Presentation: Freeze-dried Route: subcutaneous
Rubella = Togavirus
(the only togavirus that is not transmitted by arthropods)
YELLOW FEVER
Flavivirus, RNA Vector - Aedes aegypti Vaccine: Live attenuated, freeze-dried containing 17D strain Y. fever virus propagated in chick embryo.
OTHER VACCINES
TYPHOID
Organism: Commonly, Salmonella typhi, S. paratyphi A, B, C. Gram negative. Cause systemic infection but most strains cause local infection in the gut. All patients excrete organism some time in the stool. 2.5% permanent carriers especially, females.
Vaccines: 1. Heat killed monovalent, phenol preserved 2. Capsular polysaccharide typhoid vaccine (of Vi polysacc of S typhi not live) Single dose leads to 3 years protection 3. Oral vaccine - attenuated S typhi strain TY 21a as enteric coated capsule.
VARICELLA ZOSTER
90% population already infected. Infection , however, severe in adults, especially pregnant women. Zoster = flaring up of dormant varicella.
RABIES
Rhabdovirus, rod or bullet shaped, single stranded RNA Vaccine: Live attenuated, freeze dried (human dipliod vaccine)
Notes: Chloroquine prophylaxis suppresses Ab response of rabies vaccine especially if given intradermally. Guillian Barre Syndrome reported
Rabies -2
Post-exposure treatment Factors that should be taken into consideration:
vaccination status and clinical features of the animal type of vaccine used and the availability of the animal for observation
INFLUENZA
Orthomyxovirus, single standed RNA (8 stranded) High antigenic change rate
HEPATITIS A
Picorna virus (RNA) No carrier state, little likelihood of chronic liver disease. Hepatitis A vaccine: Formaldehyde inactivated
NEW VACCINES
Pneumonia with empyema/and or Bacteraemia, Febrile Bacteraemia (CF: 5 20%), or Meningitis (CF: 50 50%)
Blood Spread
1977:
Conflicting result on efficacy testing Short-lived immunity Not associated with induction of immunological memory, Requiring periodic re-vaccination to maintain protective efficacy.
2000:
The pathogen
Serotype Composition
4,6B, 9V, 14, 18C, 19F and 23F conjugated to an immunogenic mutant diphtheria (non-toxic) toxin, CRM197 PCV7 + polysaccharide from serotypes 1 and 5. 7-valent + 1, 5, 7F 10-valent + 3, 6A, 19A
PCV Administration
Dose: 0.5mls Route: Intramuscular Recipients: Infants Regimen: 3 doses at 4 weeks intervals
Meningococcal Vaccine
Meningococcal disease epidemiology:
. 4 out of 13 serogroups of N.
meningitidis (N. meningitidis. A, B, C and W135) recognized to cause epidemics. Serogroup A has shown to cause the epidemics in the meningitis belt, which extends across Africa from Senegal to Ethiopia occurring at intervals of 7-14 years.
Neisseria meningitidis also responsible for meningitis occurring beyond the neonatal and childhood period.
MENINGOCOCCUS
Organism: Neisseria meningitidus Gram negative diplococci, non motile; Serotypes BCAY W135, Groups A and C usually associated with epidemics Carriage rate in normal population 10 - 25% Short incubation period of 2-3 days.
Vaccine: Purified, heat stable lyophilised (frozen, dehydrated) extract of polysaccharide capsule of N. meningitidus effective against Group A and C.
Meningococcal Vaccines
Current internationally marketed meningococcal vaccines are based either on combinations of group-specific capsular polysaccharides (A and C, or A, C, Y, and W135) or on a conjugate between certain groups and a protein carrier. The polysaccharide vaccines are safe and highly immunogenic, although the group C component is ineffective in children under 2 years of age. On the other hand, the serogroup C conjugate vaccine is safe and efficacious even in the youngest children. (Monovalent polysaccharide vaccines are not readily available) Vaccines against group B meningococci have shown modest efficacy in both children and adults
ROTAVIRUS VACCINES
Rotavirus Infection:
Most common cause of severe diarrhoea in young children
All children infected by age 2-3 years of age First infections are symptomatic and re-infections are common Rotavirus strains in circulation
infection is associated with: severe dehydration and fever profuse watery diarrhoea and vomiting Associated with >1/3 of all hospitalizations due to diarrhoeal disease Approx 2m hospitalizations globally due to rotavirus infection Associated with high mortality due to the acute & severe dehydration
2 doses; oral live attenuated vaccine Children approx 2-4 months 1st dose given from 6 weeks but not later than 12 weeks Interval between 2 doses not more than 4 weeks 2nd dose by 16 weeks not later than 24 weeks
(G serotypes - human G1, G2, G3 and G4; bovine G6; human P1A[8] and bovine P7[5])
cross-protective of multiple strains
3 doses; given at 2, 4, 6 months 1st dose given 6-12 weeks (dont initiate vaccination to infants > 12 weeks) All doses by 32 weeks
(3) RotaShield (Wyeth): License withdrawn Trails stopped due to increased incidence of Intususception
CHOLERA
Organism: Vibrio cholerae; Gram negative curved rod. Old Vaccine: Heat killed, phenol preserved Inaba, Ogawa,
serotypes of V. cholerae 01. No longer recommended by WHO because of limited personal protection afforded.
Cervical Cancer Prevention Small, double-stranded DNA viruses that infect the cervical epithelium neoplasia. High risk oncogenic types: 16, 18 causing 70% cervical cancers 2 vaccines available: Quadrivalent Vaccine: HPV types 6, 11, 16, 18 Produced in Yeast Bivalent Vaccine: HPV types 16,18 Ideal age group to vaccinate:10-13 year old girls not a standard target population adolescent vaccination. Can be implemented for girls in last year of primary school/first year of secondary school. Catch-up vaccination in older adolescents and adult women? Not recommended in a public health programme
VACCINE REACTIONS
Vaccine Reactions
ANAPHYLAXIS
(AEFI)
A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization
Vaccine reaction - caused by vaccines inherent properties Programme error - caused by error in vaccine preparation, handling, or administration Coincidental - happens after immunization but not caused by the vaccine or vaccination process (a chance association) Injection reaction - anxiety about or pain caused by the injection not vaccine/vaccination Unknown - cause cannot be determined
Immunisation Safety -1
Vaccine Quality: Quality of biological process Character of each batch subject to variation - Hence batch numbers Diluent Characteristics Are specific for vaccine in relation to volume, pH, chemical properties Sensitivity to Heat Cold Chain
All vaccines are sensitive to heat BCG, measles, Polio can be kept in freezers DILUENTS MUST NOT BE FROZEN (e.g. Liquid vaccines containing adjuvants (aluminium salts) e.g. TT, DPT) Cool to < 8oC before reconstitution to prevent vaccine shock from sudden temperature change Previously frozen vaccines reactions and reduced immune response
CONTRAINDICATIONS
True contraindications are rare Current serious febrile illness: delay vaccine
History of severe reaction after previous dose (e.g. anaphylactic reaction) Evolving neurological disease (e.g. uncontrolled epilepsy) - avoid whole cell pertussis vaccine
No DPT or DPT/HepB/Hib to child with convulsion/shock within 3 days of the most recent dose of DPT or DPT/HepB/Hib. No DPT or DPT/HepB/Hib to child with recurrent convulsions or active CNS disease.
Type 1 hypersensitivity to egg - avoid yellow fever & influenza, can use vaccines made in chick fibroblasts
Contraindications to vaccinations - 2
Symptomatic HIV
Avoid BCG and YF Consider withholding measles vaccine in severely IC (monitor immune status) Measles not recommended if person is seriously ill
Live vaccine virus should not be given within 3 months of giving immunoglobulin because of inhibition of immune response.
Patients may be immunocompromised due to HIV , congenital immune deficiencies, immuno-suppression, e.g. steroids, chemotherapy, etc., malnutrition May not respond adequately to vaccination Risk of disseminated infection from live attenuated vaccines In some cases, recommended to weigh risk of exposure to disease (e.g., BCG in asymptomatic HIV +ve children)
Much of the immune system development occurs about the 1st and 2nd trimester. Known deficiencies in new born immune system appeared to mature as quickly in preterm infant as in term infant. Response to antigen in preterms is not significantly different from term babies (response is related to exposure and not to gestation. CMI is also demonstrable in preterms babies).
There may be uncertainties about CNS development of the prem infant, therefore need to weigh the risk of giving against the benefits or risk of postponing. Baby at risk of convulsion may convulse with an immunisation and so with pertussis vaccine. If you need to suspend pertussis then postpone the whole DPT (might not get single pertussis vaccine).
course.
Start
immunisation in 2nd month of age irrespective of degree of prematurity. OPV in neonatal unit since there is a small chance of transfer of OPV virus to other babies. Hence give OPV on discharge from nursery - not while still on admission.
Delay
All vaccines stored at 2 - 8 oC, not frozen; Except OPV, eIPV which are stored at 0-4oC. Usual dose - 0.5ml IM/deep SC except oral vaccines. Except BCG, OPV, other oral vaccines e.g. Salmonella, all vaccines given either IM or deep SC. BCG --> intradermal Rabies, typhoid, cholera, MAY be given intradermally. Wrong method reduces efficacy
Interrupted immunisation course resume, do not restart. EXCEPT for HIB (use same brand or restart with different brand)
No contraindications to the immunisation of the sick child if he/she is well enough to go home. Children with diarrhoea who are due for OPV: give but dont count, then repeat after 4 weeks and record this one as given. Dont give OPV 0 after 15 days (GHS recommendation: disturbs regular immunisation visits)
- 4th Goal: Reduce by two thirds the Mortality Rate among children <5 - 5th Goal: Improve Maternal Health
- Introducing new vaccines and technologies - Integrating immunization in the health systems context - Interdependence
operational strategy
END OF PRESENTATION
QUIZ
Parents of 8 month old baby weighing 8kg, born in USA, seek your professional advise on immunisation for their child. How will you proceed? What if baby weighed 4.5kg What if baby was born prematurely and currently weighs 5kg? What if baby was adopted from HIV positive mother?