Vaccines and Sera

1. Immunological Products
Pradeep HK
Asst. Professor
Department of Pharmaceutics
GM Institute of Pharmaceutical Sciences and Research
Davangere
www.pradeephkgmips.weebly.com

2. Terminologies
 Antigen
 Antibody
 Immunity
 Vaccines
 Sera

3. Immunity

5. Active Immunity
Here immunity of the body system enhanced by increasing the production of
antibodies by giving an antigens (vaccines).
For examples
 Live attenuated vaccines: (rubella, measles, oral polio, mumps) or bacteria -
bacillus Calmette-Guerin (BCG).
 Inactivated or Killed Vaccines (parenteral polio, hepatitis A) or parts of the
bacterium or virus (pneumococcal vaccine, influenza).
 Inactivated bacterial toxins (diphtheria and tetanus).
 Genetically engineered (hepatitis B vaccine)

6. Passive Immunity

10. Active Immunity Passive Immunity
Produced actively by the immune
system of the host
Produced passively by the immune
system of host
Antibodies production is induced by the
infection or Immunogens
Antibodies are not produced but
directly transferred
It involves cell mediated or humoral
immunity
No mediation as direct transfer of
antibodies
Natural active immunity is clinical
infection
Natural passive immunity is by transfer
of antibodies through placenta
Artificial active immunity induced by
vaccination
Artificial passive immunity is induced
by injection of antibodies
A lag period is present Lag period is absent
It is active only after the lag period Active immediately after transfer of
antibodies
Active immunity is longer duration Short term
Immunological memory is present Immunological memory absent
On subsequent doses it have booster
effect
Subsequent doses is less effective
It is not applicable for immune
deficient individuals
It is applicable for immune deficient
individuals

11. Vaccines
Vaccines are preparations of antigenic materials, which are
administered with the objective of inducing in the recipient specific and
active immunity against infectious microorganisms or toxins produced by
them. They contain living or killed microorganisms, bacterial toxoids or
antigenic material from the particular parts of bacteria, rickettsia, or
virus

12. Classification
Active Immunisation
 Live attenuated vaccines
 Inactivated or killed
vaccines
 Toxoids
 Cellular fractions
 Combinations
Passive Immunisation
 Immunoglobin
 Antisera

13. Bacterial Vaccines
Viral Vaccines
Live vaccines
 BCG vaccination.
 Typhoid vaccination (oral).
 Cholera vaccination (oral).
 Measles vaccination.
 Mumps vaccination.
 Rubella vaccination.
 Oral polio vaccination (Sabin).
 Yellow fever vaccination.
 Varicella (chickenpox) vaccination.
 Rotavirus vaccination.
 Japanese encephalitis vaccination.
Inactivated vaccines
 Pertussis (whooping cough)
vaccination.
 Cholera vaccination (oral, combined
with recombinant B subunit).
 Anthrax vaccination.
 Plague vaccination.
 Meningitis B vaccine.
 Influenza vaccination.
 Hepatitis A vaccination.
 Injectable polio vaccination (Salk).
 Rabies vaccination.
 Tick-borne encephalitis vaccination.
 Japanese encephalitis vaccination.
Toxoids
 Diphtheria vaccination.
 Tetanus vaccination.
Polysaccharide extracts of virus
 Haemophilus influenzae type B (Hib)
vaccination.
 Meningococcal A and C vaccination.
Pneumococcal vaccination. Typhoid
vaccination.
Genetically engineered  Hepatitis B vaccination.

14. Live attenuated Vaccines
 To produce a live vaccine, the wild or disease- causing virus is attenuated
(weakened), traditionally by repeated culture in the laboratory,
 The virulence properties of the virus are reduced so that it does not cause
disease in healthy individuals. The attenuated vaccine virus multiplies to a
limited extent in host tissue and induces an immune response similar to wild
virus infection in the majority of subjects. Live vaccines are generally very
effective and induce long-lived immunity.
Eg. Measles, Mumps, Rubella, Varicella, Rotavirus, Tuberculosis (BCG)

15. Killed and inactivated vaccines
The term ‘killed’ is generally used for bacterial vaccines and the term
‘inactivated’ for viral vaccines. These vaccines are prepared by treating the
whole cell or virus with chemicals that cause inactivation. Generally these
organisms remain intact and whole. They generate an immune response (to a
broad range of antigens) but cannot cause an infection because they are dead
and so cannot reproduce.
Eg. Hepatitis A, Some influenza vaccines

16. Toxoid vaccines
In some bacterial infections (eg, diphtheria, tetanus), the clinical manifestations
of disease are caused not by the bacteria themselves but by the toxins they
secrete.
Toxoid vaccines are produced by harvesting a toxin and altering it chemically
(usually with formaldehyde) to convert the toxin to a toxoid. The toxoid is then
purified. Toxoid vaccines induce antibodies that neutralise the harmful exotoxins
released from these bacteria.

17. Sera
Blood = Cells + Plasms
Plasma = water + proteins + dissolved substances
Serum = Plasma – Clotting factors

18. The serum / sera is a portion of blood remaining after coagulation of the blood,
during which process plasma protein fibrinogen is converted in to fibrin and
remains behind the clot.
Antiserum: antiserum is prepared from the blood of animals or humans that have
been exposed to disease or infections and have developed specific antibodies,
those antibodies were used to protect the persons against the disease.
Ex: Hapatoglobin, it’s a colourless protein of a α globulin fraction of human
serum

19. Preparation of Serum
The blood is allowed to clot at room temperature for 15 to 30 minutes.
When the blood has clotted completely, it is rimmed or ringed with an applicator
stick.
Then centrifuged for 5-10 minutes at 2,500 revolutions per minute (rpm).
Finally the supernatant fluid is then separated making use of a Pasteur pipette,
and labeled accordingly.

20. Differences between Vaccines and Sera
Vaccines Sera
Vaccines are preparations of antigenic
materials, which are administered with
the objective of inducing in the recipient
specific and active immunity against
infectious microorganisms or toxins
produced by them.
The clear, pale yellow liquid that separates
from the clot in the coagulation of blood.
Or
Serum is a portion of blood remaining after
coagulation of blood.
Contain dead bacteria or weak bacteria or
toxins
Do not contain any bacteria or toxins
Stimulates the body to make antibodies Acquired immune immediately
Immunity remains for longer time Immunity remains for shorter time
Obtained from series of complex process
to get live or inactivated vaccines
Specific animal by immunisation, whole
blood is collected in, but the serum is non-
specific mixture obtained after
centrifugation.
Normally it consists of single type of
monoclonal antibodies or may be for a
particular disease.
It may contain monoclonal or polyclonal
antibodies (antiserum)

21. Methods of Preparation

24. Preparations of Bacterial Vaccines
Method
Sterilised via low thermal or filtration
Ex :Bacillus Calmette Guerin Vaccine (BCG, Tub, Vac)
Cholera Vaccine (Vibrio Cholera vaccine)
Pertussis Vaccine ( Whooping cough vaccine)
Plague Vaccine
Gen Storage options
Store in dark between 2 to 8 °C
B.C.G (Mycobacterium tuberculosis live) – Liquid /dry
Liquid form – 14 days shelf life
Dry form – 12 months

25. Baceterial Toxoins

26. Bacterial toxoids
Toxins
Endo and exotoxins
formaldehyde
Toxin Toxoid
Precipatation of Toxoid with Alum, flocculating it with corresponding antitoxin
Or adsorbing on aluminium hydroxide or hydrated aluminium phosphate.
Precipitate is washed and resuspended in isotonic solution with blood.
 Diphtheria vaccination.
 Tetanus vaccination

27. Viral or Rickettsial Vaccines
 Generally they are resistant to Treatment of antibiotic and chemotherapeutic
agents
 Generally prepared from infected tissues, or from the animal, which have
been deliberately infected with virus or rickettsiae. (rabies, small pox)
 Host (fertile Egg) / Cell cultures (poliomyelitis, small pox)
 Living (live attenuated strains) – Non pathogenic
 Pathogenic - inactivation/ limitations of its activity by treating with
formaldehyde or low thermal activity
Note : Small pox is availalable in both dry and liquid form
Yellow fever vaccine is available only in dry form and other vaccines available in
liquid forms.

28. Storage
Viral /rickettsial
Vaccine
Temperature Shelf Life
Poliomyelitis Frozen State Two years
0 to 4°C Six months
18 to 20°C 7 days
Liquid Small Pox -10 to -20°C 12 months
2 to 8°C Two weeks
10 to 20°C One week
Dried Small pox 2 to 10°C Indefinitely
At 29°C 1 year
Yellow Fever Dry
state
4°C 1 year
Rabies 2 to 4°C Six months
In general other viral or rickettsial vaccines stored between 2 to 8°C in dark place

29. Thank you