Description of vaccines, their pharmacology, National Immunization schedule and antisera

1. Vaccines and Antisera
Dr Naser Ashraf Tadvi

2. Immunity
• Active Immunity
• Development of antibodies by individual himself
• It can be natural & species specific (horse, dogs, rats -TB)
• It can be produced by introduction of an antigen
• Passive immunity
• Acquired by transfer of antibodies from donor to recipient
• Natural: fetus receiving maternal antibodies
• Acquired: by administration of sera containing immunoglobulins

3. Herd Immunity
• Vaccination of a portion of population (Herd) provides protection to
unprotected individuals
• Difficult to maintain a chain of infection when large population immune
• If herd immunity is sufficiently high, occurrence of epidemic highly unlikely
• May lead ( not necessarily) to elimination of disease in due course
• Achieved in diseases like diphtheria and poliomyelitis
• Neither possible nor necessary to achieve 100% herd immunity in a
population to halt epidemic or control disease ( no definite answer)
• Herd immunity may be determined by serological surveys

4. Vaccine
• Immuno-biological substance designed to produce specific protection
against a given disease
• Stimulates production of protective antibody and other immune
mechanisms
• May be prepared from
• Live modified organisms
• Inactivated or killed organisms
• Extracted cellular fractions , toxoids (Subunit vaccines)

5. Types of vaccines
Live
attenuated
Killed whole
organism
Toxoid/ Protein Polysaccharide Glycoconjugate Recombinant
• BCG
• Ty 21a (Oral)
• OPV
• Mumps
• Measles
• Rubella
• Varicella
• Yellow fever
• Typhoid-
Paratyphoid(TAB)
• Cholera
• Pertussis
• Plague
• Polio (IPV)
• Rabies (PCEV,
HDCV, PVRV)
• HAV
• Diptheria
• Tetanus
• Vi Typhoid
Polysaccharide
• Hib
• Pneumococcus
• HBV
• HPV

6. Live attenuated vaccines
• Prepared from live or wild (attenuated) organisms
• These organisms have been passed repeatedly in laboratory in tissue
culture or chick embryos and lost their ability to produce full blown
disease but retain their immunogenicity
• More potent than killed vaccines

7. Contraindications of live vaccines
• Leukemia or other malignancies, especially receiving cytotoxic drugs
• Pregnancy
• SLE
• Corticosteroid recipients
• AIDS and other immune deficiency states
• If two lives vaccines need to be given
• Give simultaneously at different sites or with gap of atleast 3 weeks

8. Killed (Inactivated) Vaccines
• Growing virus or bacteria in culture media then inactivating them
with heat/ chemicals (usually formalin)
• Usually safe but less efficacious
• Usually administered by SC/IM route
• Usually shortlasting immunity, booster doses are needed at intervals
Typhoid-Paratyphoid(TAB)
Cholera
Pertussis
Plague
Polio (IPV)
Rabies (PCEV, HDCV, PVRV)
HAV

9. Toxoids
• Modified bacterial exotoxins
• Toxicity is lost but antigenicity is retained
• Highly efficacious and safe immunizing agents

10. Other components in vaccine (Excipients)
• Adjuvants
• Substances added to enhance degree or duration of immune response
• Aluminium salts
• Antibiotics
• Added to prevent bacterial contamination of tissue culture cells
• MMR vaccine , IPV vaccine (Neomycin)
• Preservatives
• Thiomersal, formaldehyde
• Stabilizers
• Lactose, sodium and potassium salts, human serum albumin, gelatin

11. Typhoid vaccine
Parenteral
• Typhoid- Paratyphoid A,B (TAB)
• S. Typhi 109, S. paratyphi 7.5 x 108/ ml
• Dose: 0.5 ml s.c , 2-3 injections at 2-4
weeks interval
• Vi typhoid polysaccharide vaccine
• Purified Vi capsular antigen of S.typhi
• More effective and longer lasting
• Dose: 0.5 ml s.c/i.m
• Repeat after 3 years
Oral
• Typhoid-Ty21a Oral vaccine
• Prepared from Ty21a attenuated
strain of S.Typhi
• Lodges in intestinal mucosa &
prevents S.Typhi invasion of gut
• Also imparts systemic immunity
• Efficacy better than TAB
• 67-90% protection for 3 years
• 1 capsule alternate days in
between meals (3 doses)

12. Cholera vaccine
• Suspension of phenol/ formalin killed inaba and ogawa strains of V.
cholerae
• 8x 109 organisms/ ml
• Dose: 0.5 ml s.c/i.m followed by 1 ml 1-4 weeks later
• Immunity produced in <50% and lasts only 6 months

13. Pertussis vaccine
• 2x108 /ml suspension of killed B. Pertussis
• 0.5 ml i.m, 3 doses at 4-week interval
• Adverse effects:
• Local pain, induration, high fever
• Hypotonic hyporesponsive child
• Convulsions, focal neurological symptoms
• Contraindications
• History of convulsions or other neurological signs

14. Meningococcal vaccine
• Purified Polysaccharide capsular antigen of N.meningitis
• Used in epidemics
• 0.5 ml single dose in > 2-year age
• Adverse effects:
• Transient fever, local reaction

15. H.Influenza type b (Hib)
• H. influenza is important cause of meningitis and pneumonia among
children in developing countries
• High cost
• Often given with DPT and polio vaccine
• Generally not given to children > 24 months old

16. BCG vaccine
• Live attenuated vaccine against Tuberculosis
• Induces Cell mediated immunity
• Available as lyophilised (freeze dried) powder
• Reconstituted with sterile normal saline
• Dose – 0.05ml (neonates) , 0.1ml (infants and children)
• Route of administration – intradermal

17. Poliomyelitis vaccine
• Oral poliovirus vaccine ( Sabin)
• Inactivated poliomyelitis vaccine (Salk)

18. Oral Polio vaccine
• Poliovirus family of Picornaviridae
• The virus (type I, 2, 3) is grown in monkey kidney cell culture
• The virus invades the nervous system & can cause permanent
paralysis
• Types of oral polio vaccine (Sabin)
• Trivalent, bivalent, monovalent
• Dose: 2 drops directly in mouth
• Given at birth then 6, 10, 14 weeks, booster between 15-18 months
and at school entry

19. Inactivated polio vaccine (Salk)
• Preferred over Oral polio vaccine only in
1. Primary immunization in adults
2. In persons with compromised immune system.
• Dose:
• 1ml /s.c. in the deltoid region at 4-6 week intervals (3 doses)
• fourth dose is given 6-12 months later, booster doses -5 years.
• Adverse effects:
• Fever and local pain are common.
• Allergic reactions sometimes occur

20. Rabies vaccine
1. Purified chick embryo cell vaccine (PCEV)
• Flury-LEP strain of rabies virus grown on chick fibroblasts
• Neuroparalytic complications have been reported rarely.
• Local pain, erythema, swelling and lymph node enlargement can occur.
2. Human diploid cell vaccine (HDCV)
• lyophilized inactivated rabies virus grown in human diploid cell culture
• Slight induration lasting 1- 2 days occurs (10%), Fever and arthralgia (1 %)
• 100% effective and well tolerated, No Vaccine associated encephalitis
3. Purified vero cell rabies vaccine (PVRV)
• Contains inactivated wistar rabies strain grown on vero continuous cell line

21. Post exposure prophylaxis for Rabies
• Given to all non immunised animal-bite cases suspected to have been
exposed to the rabies virus.
• The intradermal regimen (Thai regimen):
• Requires only 1/5th dose of the earlier used i.m. regimen
• Less expensive, more convenient and equally efficacious.
• 0.1 ml of PCEV or PVRV or 0.2 ml of HDCV injected i.d. at 2 sites (over deltoid
of both arms) on days 0, 3, 7 & 28 (2 + 2 + 2+ 0 + 2).
• Thus, no injection is given on day 14 as in earlier i.m. regimen
• concurrent administration of rabies immunoglobulin (RIG) is
recommended in category III bites

22. Categories of contact and recommended Post Exposure
Prophylaxis (PEP)
Category Description Post Exposure prophylaxis
measures
Category 1 • Touching or feeding animal,
• Licks on intact skin
None
Category 2 • Nibbling of uncovered skin
• Minor scratches or abrasions without bleeding
Immediate vaccination and
local treatment of the wound
Category 3 • Single or multiple transdermal bites or
scratches, licks on unbroken skin
• Contamination of mucous membrane with
saliva from licks
• Contact with Bats
Immediate vaccination and
administration of rabies
immunoglobin
Local treatment of the wound

24. Hepatitis B vaccine
• The new hepatitis B vaccine is prepared in yeast cells by recombinant
DNA technique
• Contains aluminium hydroxide adsorbed hepatitis B virus surface
antigen 20 µg in 1 ml suspension.
• Three I ml injections in the deltoid muscle given at 0, I and 6 months
produce protective antibody titers in 99% subjects.
• Children < 10 yr are given 0.5 ml doses in the thigh. L
• Induration and soreness at injection site and occasional fever and
malaise are the adverse effects.

25. Measles, Mumps, Rubella, Varicella
Measles Mumps Rubella Chicken pox
Rubeola Parotitis German measles Varicella
Family Paramyxoviridae Family Paramyxoviridae Family Toga viridae Family orthopox virus
The skin rash normally
lasts about 5 to 10 days
Lesions of the oral
cavity include
diagnostically useful
Bright red Kopliks spots
Mumps affects the
parotid glands, salivary
glands
Swelling below and in
front of the ears
A rash of small red
spots
Red itchy skin rash with
blisters
Fever
Feeling tired
Headache

26. Mumps Vaccine
• Live attenuated vaccine prepared from mumps virus grown in cell
culture of chick embryo.
• A single dose of 5000 TCID50, affords protection for 10 years
• Revaccination is not required.
• Generally combined with measles and rubella vaccine (MMR), and is
not recommended below 1 year of age.
• A mild febrile reaction occurs occasionally.

27. Measles vaccine
• Live attenuated Vaccine grown on chick embryo
• Available in single dose vials containing 1000 TCID50 of Edmonston
Schwartz /Zagreb strain for s.c. injection over right deltoid region.
• It produces a modified infection: fever. rash and coryza may appear
after 5-10 days
• Immunity lasts 8 years and no booster doses are required.
• Recommended in children 9 months or older
• Some protection even if given after exposure

28. Rubella Vaccine
• Live attenuated virus Wistar RA27/3 strain 1000 TCID50 per/ 0.5 ml inj.
• It is used especially in girls from 1yr age to puberty- for immunization
against German measles; mostly as combined MMR vaccine.
• Contraindicated during pregnancy, febrile illness and untreated
tuberculosis patients.
• Reactions are fever, malaise, sore throat, joint pain & lymphadenopathy

33. Antisera
• Purified & concentrated preparations of serum of horses/rabbits
actively immunized against a specific antigen.
• Adverse effects
• Immediate type of allergic reactions
• urticaria, angioedema, respiratory distress, anaphylaxis
• Serum sickness with fever, rash, joint pain, lymphadenopathy
• appears 7- 12 days later,
• Frequent after large doses and repeated administration.
• Local pain, erythema may occur 7-10 days after i.m. injection.

34. Immunoglobulins
• Separated human gamma globulins which carry the antibodies
• Non-specific (Normal) or specific (hyperimmune) against a particular
antigen
• More efficacious than antisera
• Usually no hypersensitivity
• Tendency increases with large and repeated dosing, adrenaline to be
kept on standby

36. Tetanus
Tetanus immune globulin (human)
• Prophylaxis in non-immunized persons with contaminated wound
• It is more efficacious and longer acting than the equine antitoxin (ATS).
• Efficacy is variable for the treatment of clinical tetanus
• Dose: prophylactic 250-500 IU therapeutic, 3000-6000 IU i.m
Anti-tetanic serum (Tetanus antitoxin)
• Obtained from horse and is inferior to human antitoxin.
• It should be used only when tetanus immune globulin is not available
• Dose:
• Prophylactic 1500-3000 IU. i.m. or s.c.,
• Therapeutic 50,000 100.000 IU part Iv, and rest i.m.

37. Anti-Snake Venom Polyvalent
• Purified, enzyme refined and concentrated equine globulins
• Lyophilized vials with 10 ml ampoule of distilled water
• After reconstitution each ml neutralizes
• 0.6 mg of standard cobra venom
• 0.6 mg of standard Russell's Viper venom
• 0.45 mg of standard Sawscaled viper venom
• 0.45 mg of standard Krait venom

38. Anti-snake venom Polyvalent
• Dose: 20 ml i.v. (1ml/min), 1-6 hourly intervals till symptoms of
envenomation disappear
• 300 ml may be required in viper bites & larger amounts (upto 900 ml)
have been used in cobra bites
• Viper bite some serum should also be infiltrated around the site
• Allergic reactions, including anaphylactic shock possible.
• If possible do sensitivity test or Give adrenaline concurrently (s.c)
• Antihistaminic & glucocorticoid may also be given prophylactically.

40. Normal Human Gamma Globulin
• Concentrated immunoglobulin obtained by cold fractionation of
pooled human plasma.
• Indications
• Viral hepatitis A and B (prophylaxis),
• Measles, mumps, poliomyelitis and chickenpox
• Agammaglobulinemia, leukemia, patients undergoing immunosuppression.
• It can augment the response to antibiotics in debilitated patients
• Dose: 0.02-1ml/kg i.m