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VACCINES, TOXOIDS,
ANTISERA AND
IMMUNOGLOBULINS
Dr. Bikram Tewari
Assistant Professor
Department of
Pharmacology
INTRODUCTION
Vaccines, Antisera and Toxoids are biological
products which act by reinforcing the
immunological defence of the body against
foreign agencies.
Mostly used in public health programmes
Potentially dangerous, strictly supervised and
highly standardised production, distribution and
administration.
Need cold storage to maintain potency
HISTORY
Small Pox-
1798
Rabies-1885
Typhoid -
1896
Cholera- 1896
Plague-1897
Polio-1955 JONAS SALKEDWARD JENNER
VACCINES:
Active
immunity,
prophylactic,
latent
period.
ANTISERA
and
IMMUNO-
GLOBULINS:
Passive
immunity,
curative,
immediate
ACTIVE
IMMUNITY
Bacterial
• Live attenuated
• Killed Inactivated
Viral
• Live attenuated
• Killed Inactivated
Toxoid
Combined
Vaccine
PASSIVE
IMMUNITY
•ANTISERA
•IMMUNOGLOBULIN
BACTERIAL VACCINE
• Bacillus Calmette – Guerin (BCG)
• Typhoid – Ty21a
LIVE ATTENUATED
• Typhoid- Parathyphoid (TAB)
• Vi Polysaccharide
• Cholera
• Whooping Cough
• Meningococcal
• Haemophilus Influenzae Type b
• Plague
KILLED INACTIVATED
BACILLUS CALMETTE-GUERIN
(BCG) VACCINE
BACILLUS CALMETTE-GUERIN
(BCG) VACCINE
Live vaccine, attenuated bovine strain of M.
tuberculosis
Calmette and Guerin – 1921, France
Supplied as 0.5 to 1mg dry powder to be
suspended in 1ml sterile water
Neonate: 0.05ml and Older individuals: 0.1ml,
intra-cutaneous in deltoid region
Tuberculin sensitivity testing required in children
and adults
TUBERCULIN SENSITIVITY TESTING
 Evaluation of
testing Site:
48-72 hrs
 Also known
as Mantoux
Screening
Test, Mendel
Mantoux,
Pirquet, PPD
test
TUBERCULIN SENSITIVITY TESTING
- RESULTS
BCG
Vaccinati
on
SCAR
BACILLUS CALMETTE-GUERIN
(BCG) VACCINE
Injection Site
o7-10 days: red painless papule
o5 weeks: reaches 8mm, axillary L/N swelling
o3 months: Scales and dries
o6 Months: total heal
Partial, non permanent, non predictable.
Children benefited more
Also used for enhancement of immunity (non
specifically)
C/I: tuberculin positive, compromised host
VIRAL VACCINE
•Poliomyelitis Oral Live (OPV, Sabin)
•Measles, Mumps and Rubella
LIVE ATTENUATED
•Poliomyelitis inactivated (IPV, Salk)
•Rabies (Brain Substance, Chick embryo cell, Human diploid Cell-HDCV, Vero
Cell)
•Influenza
•Hepatitis B
•Hepatitis A
KILLED INACTIVATED
VACCINE FOR POLIOMYELITIS
Virus type 1, 2 and 3
Grown in monkey kidney cell culture
Two vaccines
oOral Polio Vaccine (OPV; Sabin vaccine): 0.5ml oral
drops at 6 10 and 14 weeks. Booster dose in15 to 18
months
oInactivated Poliomyelitis Vaccine (IPV, Salk Vaccine): 3
doses of 1ml s.c. injection in deltoid region at 4-6
weeks intervals. 4th dose 6-12 months later. Booster
dose every 5 years.
RABIES VACCINE
Four vaccine types
1. Antirabic vaccine carbolized
(Semple Vaccine)
2. Purified chick embryo cell
vaccine (PCEV)
3. Human diploid cell vaccine
(HDCV)
4. Purified vero cell mrabies
vaccine (PVRV)
POST EXPOSURE
PROPHYLAXIS
1ml of PCEV or
HDCV or 0.5ml of
PVRV per dose
given on day 0, 3,
7, 14, 30, 90
PRIMARY
IMMUNIZATION
PCEV: 3 doses of
1ml inj. at intervals
of 1 month.
Booster: 1 year
HDCV: 3 doses 1ml
injection at 1week
HEPATITIS VACCINES
HEPATITIS B
•Aluminium
hydroxide
adsorbed Hep B
virus surface
antigen
•Prepared in yeast
cells
•1ml i.m. deltoid at
0, 1 and 6 months
•Children: 0.5ml in
HEPATITIS A
•Inactivating with
formaldehyde
•Hep A virus grown
in Human Diploid
Cell Culture
•0.5ml injection
i.m. deltoid
•Booster: 6 months
COMBINED
VACCINE
Measles-
Mumps-
Rubella (MMR)
Pentavalent
Vaccine
Double
antigen
DT-DA
Triple Antigen
DPT
4. MEASLES-MUMPS-RUBELLA
(MMR) VACCINE
Two preparations available
1
2
MEASLES-MUMPS-RUBELLA (MMR)
VACCINE
MUMPS VIRUS VACCINE LIVE ATTENUATED
•Virus grown in chick embryo cell culture
•Live attenuated, dose of 5000 TCID50
•Affords protection for up to 10 years
•Not to be given in immune deficiency syndrome
or after exposure
•Occasional febrile reaction
MEASLES-MUMPS-RUBELLA (MMR)
VACCINE
MEASLES VACCINE LIVE ATTENUATED
•Virus grown in chick embryo cell culture –
Edmonston Schwarz strain or Edmonston
Zagreb strain
•Live attenuated, dose of 1000 TCID50
•Affords protection for up to 8 years
•Not to be given in immune deficiency, history
of febrile convulsion or family history of
epilepsy
•Affords some protection even when given post
MEASLES-MUMPS-RUBELLA (MMR)
VACCINE
RUBELLA VACCINE
•Live attenuated, Wistar RA27/3 strain
•1000 TCID50 , more specifically for girls
•Contraindicated in pregnancy, febrile illness and
untreated tuberculosis
•A/E: fever, malaise, sore throat, joint pain and
lymphadenopathy
PENTAVALENT VACCINE
PENTAVALENT VACCINE
DIPTHERIA TOXOID ADSORBED
•Modified diphtheria exotoxin
adsorbed onto aluminium
hydroxide
•Reactions: local erythema, pain
and induration, axillary lymph
nodes may enlarge, fever, chills,
malaise, aches and pains
PENTAVALENT VACCINE
PERTUSIS (WHOOPING CHOUGH)
VACCINE
•Killed B. pertussis
•Also induces diminished adrenergic
reactivity and aids sensitization to
other antigens
•Reactions: local pain, induration,
rarely severe systemic reactions –
high fever, shock like state,
convulsions, altered consciousness,
focal neurological signs
PENTAVALENT VACCINE
TETANUS TOXOID
•Formalin treated exotoxin of tetanus bacilli
•Two types: fluid and adsorbed
•Reactions are similar to diphtheria toxoid
adsorbed
•Concomitant administration of chloramphenicol is
avoided as it interferes with antibody response
•Unimmunized or inadequately immunized
individual: inject after every injury that is likely to
PENTAVALENT VACCINE
INFLUEZAE VIRUS VACCINE
•Contains inactivated influenza virus A and B
•Efficacy inconsistent because of the frequent
antigenic changes
•A/E: Local induration and tenderness, fever,
malaise and myalgia, allergic reactions to egg
protein
PASSIVE
IMMUNITY
•ANTISERA
•IMMUNOGLOBULIN
ANTISERA
Purified and concentrated preparations of serum of
horses actively immunized against a specific antigen
A/E
1.Immediate type of allergic reactions: adrenaline
1:1000 on standby, proper sensitivity history, intra-
cutaneous/scratch test required – C/I in positive
2.Serum Sickness: with large doses and frequent
administration. Fever, rash, joint pain,
lymphadenopathy 7-12 days later
IMMUNOGLOBULINS
oSeparated human gamma globulins which carry
the antibodies.
oNon specific (normal) or specific (hyperimmune)
against a particular antigen
oMore efficacious than antisera
oUsually no hypersensitivity
oTendency increases with large and repeated
dosing: adrenaline to be kept on standby
ANTISERA (From
Horse)
oTetanus antitoxin (ATS)
oGas Gangrene Antitoxin
(AGS)
oAnti Rabies Serum (ARS)
oAnti-snake venom
polyvalent
IMMUNOGLOBULINS
(Humans)
oNormal Human Gamma
Globulin
oAnti – D immunoglobulin
oTetanus immunoglobulin
oRabies Immunoglobulin
oHepatitis-B
immunoglobulin
ANTI-SNAKE VENOM POLYVALENT
Purified, enzyme refined and concentrated equine
globulins
Lyophilized vials with 10 ml ampule of distilled
water
ml neutralizes
1. 0.6 mg of standard Cobra(Naja naja) venom
2. 0.6 mg of standard Russel’s Viper (Vipera russelli)
venom
3. 0.45 mg of standard Sawscaled viper (Echis
1
3
2
4
ANTI-SNAKE VENOM POLYVALENT
Dose: 20ml i.v. (1ml/min injections) repeated at
1-6 hourly intervals till symptoms of envenomation
disappear
Upto 300ml/patient. Max
In viper bite: some serum around the bite site as
well
Allergic reactions including anaphylactic shock
possible
Sensitivity testing or adrenaline s.c injection
according to the situation
NORMAL HUMAN GAMMA GLOBULIN
NORMAL HUMAN GAMMA GLOBULIN
Concentrated IG obtained by fractionation in cold
From pooled human plasma
Indicated use in: Viral hepatitis A and B, Measles,
Mumps, Poliomyelitis, Chicken Pox
Valuable in agammaglobinemia, premature infants,
leukaemia, immunosuppression
Also augments response to antibiotics
Dose: 0.02 – 1ml/kg i.m
THANK YOU

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Vaccines, antisera and immunoglobulins

  • 1. VACCINES, TOXOIDS, ANTISERA AND IMMUNOGLOBULINS Dr. Bikram Tewari Assistant Professor Department of Pharmacology
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  • 3. INTRODUCTION Vaccines, Antisera and Toxoids are biological products which act by reinforcing the immunological defence of the body against foreign agencies. Mostly used in public health programmes Potentially dangerous, strictly supervised and highly standardised production, distribution and administration. Need cold storage to maintain potency
  • 4. HISTORY Small Pox- 1798 Rabies-1885 Typhoid - 1896 Cholera- 1896 Plague-1897 Polio-1955 JONAS SALKEDWARD JENNER
  • 6. ACTIVE IMMUNITY Bacterial • Live attenuated • Killed Inactivated Viral • Live attenuated • Killed Inactivated Toxoid Combined Vaccine
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  • 12. BACTERIAL VACCINE • Bacillus Calmette – Guerin (BCG) • Typhoid – Ty21a LIVE ATTENUATED • Typhoid- Parathyphoid (TAB) • Vi Polysaccharide • Cholera • Whooping Cough • Meningococcal • Haemophilus Influenzae Type b • Plague KILLED INACTIVATED
  • 14. BACILLUS CALMETTE-GUERIN (BCG) VACCINE Live vaccine, attenuated bovine strain of M. tuberculosis Calmette and Guerin – 1921, France Supplied as 0.5 to 1mg dry powder to be suspended in 1ml sterile water Neonate: 0.05ml and Older individuals: 0.1ml, intra-cutaneous in deltoid region Tuberculin sensitivity testing required in children and adults
  • 15. TUBERCULIN SENSITIVITY TESTING  Evaluation of testing Site: 48-72 hrs  Also known as Mantoux Screening Test, Mendel Mantoux, Pirquet, PPD test
  • 18. SCAR
  • 19. BACILLUS CALMETTE-GUERIN (BCG) VACCINE Injection Site o7-10 days: red painless papule o5 weeks: reaches 8mm, axillary L/N swelling o3 months: Scales and dries o6 Months: total heal Partial, non permanent, non predictable. Children benefited more Also used for enhancement of immunity (non specifically) C/I: tuberculin positive, compromised host
  • 20. VIRAL VACCINE •Poliomyelitis Oral Live (OPV, Sabin) •Measles, Mumps and Rubella LIVE ATTENUATED •Poliomyelitis inactivated (IPV, Salk) •Rabies (Brain Substance, Chick embryo cell, Human diploid Cell-HDCV, Vero Cell) •Influenza •Hepatitis B •Hepatitis A KILLED INACTIVATED
  • 21. VACCINE FOR POLIOMYELITIS Virus type 1, 2 and 3 Grown in monkey kidney cell culture Two vaccines oOral Polio Vaccine (OPV; Sabin vaccine): 0.5ml oral drops at 6 10 and 14 weeks. Booster dose in15 to 18 months oInactivated Poliomyelitis Vaccine (IPV, Salk Vaccine): 3 doses of 1ml s.c. injection in deltoid region at 4-6 weeks intervals. 4th dose 6-12 months later. Booster dose every 5 years.
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  • 23. RABIES VACCINE Four vaccine types 1. Antirabic vaccine carbolized (Semple Vaccine) 2. Purified chick embryo cell vaccine (PCEV) 3. Human diploid cell vaccine (HDCV) 4. Purified vero cell mrabies vaccine (PVRV)
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  • 25. POST EXPOSURE PROPHYLAXIS 1ml of PCEV or HDCV or 0.5ml of PVRV per dose given on day 0, 3, 7, 14, 30, 90 PRIMARY IMMUNIZATION PCEV: 3 doses of 1ml inj. at intervals of 1 month. Booster: 1 year HDCV: 3 doses 1ml injection at 1week
  • 26. HEPATITIS VACCINES HEPATITIS B •Aluminium hydroxide adsorbed Hep B virus surface antigen •Prepared in yeast cells •1ml i.m. deltoid at 0, 1 and 6 months •Children: 0.5ml in HEPATITIS A •Inactivating with formaldehyde •Hep A virus grown in Human Diploid Cell Culture •0.5ml injection i.m. deltoid •Booster: 6 months
  • 28. 4. MEASLES-MUMPS-RUBELLA (MMR) VACCINE Two preparations available 1 2
  • 29. MEASLES-MUMPS-RUBELLA (MMR) VACCINE MUMPS VIRUS VACCINE LIVE ATTENUATED •Virus grown in chick embryo cell culture •Live attenuated, dose of 5000 TCID50 •Affords protection for up to 10 years •Not to be given in immune deficiency syndrome or after exposure •Occasional febrile reaction
  • 30. MEASLES-MUMPS-RUBELLA (MMR) VACCINE MEASLES VACCINE LIVE ATTENUATED •Virus grown in chick embryo cell culture – Edmonston Schwarz strain or Edmonston Zagreb strain •Live attenuated, dose of 1000 TCID50 •Affords protection for up to 8 years •Not to be given in immune deficiency, history of febrile convulsion or family history of epilepsy •Affords some protection even when given post
  • 31. MEASLES-MUMPS-RUBELLA (MMR) VACCINE RUBELLA VACCINE •Live attenuated, Wistar RA27/3 strain •1000 TCID50 , more specifically for girls •Contraindicated in pregnancy, febrile illness and untreated tuberculosis •A/E: fever, malaise, sore throat, joint pain and lymphadenopathy
  • 33. PENTAVALENT VACCINE DIPTHERIA TOXOID ADSORBED •Modified diphtheria exotoxin adsorbed onto aluminium hydroxide •Reactions: local erythema, pain and induration, axillary lymph nodes may enlarge, fever, chills, malaise, aches and pains
  • 34. PENTAVALENT VACCINE PERTUSIS (WHOOPING CHOUGH) VACCINE •Killed B. pertussis •Also induces diminished adrenergic reactivity and aids sensitization to other antigens •Reactions: local pain, induration, rarely severe systemic reactions – high fever, shock like state, convulsions, altered consciousness, focal neurological signs
  • 35. PENTAVALENT VACCINE TETANUS TOXOID •Formalin treated exotoxin of tetanus bacilli •Two types: fluid and adsorbed •Reactions are similar to diphtheria toxoid adsorbed •Concomitant administration of chloramphenicol is avoided as it interferes with antibody response •Unimmunized or inadequately immunized individual: inject after every injury that is likely to
  • 36. PENTAVALENT VACCINE INFLUEZAE VIRUS VACCINE •Contains inactivated influenza virus A and B •Efficacy inconsistent because of the frequent antigenic changes •A/E: Local induration and tenderness, fever, malaise and myalgia, allergic reactions to egg protein
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  • 41. ANTISERA Purified and concentrated preparations of serum of horses actively immunized against a specific antigen A/E 1.Immediate type of allergic reactions: adrenaline 1:1000 on standby, proper sensitivity history, intra- cutaneous/scratch test required – C/I in positive 2.Serum Sickness: with large doses and frequent administration. Fever, rash, joint pain, lymphadenopathy 7-12 days later
  • 42. IMMUNOGLOBULINS oSeparated human gamma globulins which carry the antibodies. oNon specific (normal) or specific (hyperimmune) against a particular antigen oMore efficacious than antisera oUsually no hypersensitivity oTendency increases with large and repeated dosing: adrenaline to be kept on standby
  • 43. ANTISERA (From Horse) oTetanus antitoxin (ATS) oGas Gangrene Antitoxin (AGS) oAnti Rabies Serum (ARS) oAnti-snake venom polyvalent IMMUNOGLOBULINS (Humans) oNormal Human Gamma Globulin oAnti – D immunoglobulin oTetanus immunoglobulin oRabies Immunoglobulin oHepatitis-B immunoglobulin
  • 44. ANTI-SNAKE VENOM POLYVALENT Purified, enzyme refined and concentrated equine globulins Lyophilized vials with 10 ml ampule of distilled water ml neutralizes 1. 0.6 mg of standard Cobra(Naja naja) venom 2. 0.6 mg of standard Russel’s Viper (Vipera russelli) venom 3. 0.45 mg of standard Sawscaled viper (Echis
  • 46. ANTI-SNAKE VENOM POLYVALENT Dose: 20ml i.v. (1ml/min injections) repeated at 1-6 hourly intervals till symptoms of envenomation disappear Upto 300ml/patient. Max In viper bite: some serum around the bite site as well Allergic reactions including anaphylactic shock possible Sensitivity testing or adrenaline s.c injection according to the situation
  • 47. NORMAL HUMAN GAMMA GLOBULIN
  • 48. NORMAL HUMAN GAMMA GLOBULIN Concentrated IG obtained by fractionation in cold From pooled human plasma Indicated use in: Viral hepatitis A and B, Measles, Mumps, Poliomyelitis, Chicken Pox Valuable in agammaglobinemia, premature infants, leukaemia, immunosuppression Also augments response to antibiotics Dose: 0.02 – 1ml/kg i.m