Immunological Preparations – PST05103 Pharmaceutical Microbiology

NTA Level 5 • Semester 1 • PST05103

Immunological Preparations

Pharmaceutical Microbiology • Source Session/Topic 49
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Session 49: Immunological Preparations

Total Session Time: 120 minutes

Pre-requisites

• Human anatomy and physiology

Students Learning Tasks

By the end of this session students are expected to be able to:

• List characteristics of immunological preparations
• List immunological preparations
• Define vaccines and sera
• Differentiate between vaccine and sera
• List components of vaccines and sera
• Classify vaccines and list their characteristics

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

|Step |Time |Activity/ |Content |

| | |Method | |

|1 |5 minutes |Presentation |Introduction, Learning Tasks |

|2 |20 minutes |Presentation |Immunological Preparations |

|3 |15 minutes |Presentation |Vaccines and Sera |

|4 |40 minutes |Presentation |Classification of Vaccines and |

| | | |Sera |

|5 |30 minutes |Presentation |Composition of Vaccines and Sera |

|6 |5 minutes |Presentation |Key Points |

| 7|5 minutes |Presentation |Evaluation |

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Immunological Preparations (20 minutes)

• Immunological preparations

o Immunological preparations are a group of pharmaceutical

preparations with diverse origins but with a common

pharmacological purpose of modifying the immune status of a

recipient, either to provide immunity to infectious disease or to

help in detection (diagnosis) of a disease

o Types of immunological preparations

▪ Vaccines
▪ Immune sera
▪ In-vivo diagnostics
▪ Immunoglobulins
• Characteristics of Immunological Preparations

o They modify the immune system

o They contain antigens or antibodies/immunoglobulins

o They produce specific responses

STEP 3: Vaccines and Immune sera (15 minutes)

• Vaccine

o Vaccine is a biological preparation that consists of either a

whole organism (killed or live attenuated) or part of an organism

introduced into an individual to induce adequate antibody

production against the organism so that the individual is

protected against infection caused by that particular organism

o Vaccines contain antigens that stimulate the immune system of the

recipient to produce T-cells or antibodies that attack and destroy

the infectious agent

• Immune Sera

o Immune sera (singular serum) also known as antisera are amber-

coloured, protein-rich liquid that separates out when blood

coagulates

o Blood serum of an animal is used to provide immunity to a pathogen

or toxin by inoculation or used as a diagnostic agent

o The sera contain antibodies against specific disease and used to

provide passive immunity to that diseases. Sera do not stimulate

production of antibodies

o Immune sera are prepared by injecting repeated doses of an antigen

into horse or other suitable animal

o The animal is injected until high titre of antibodies are produced

by the body of the animal

o The animal must be in good health and free from infections

o Blood is obtained from the animal and processed to produce serum

• Human Immunoglobulins

o Are preparations of immunoglobulins principally IgG subclasses

that are present in human blood

o They are derived from plasma of donated blood and from plasma

obtained from plasmapheresis

o Specific immunoglobulins are prepared from smaller pools of plasma

obtained from individuals who have suffered recent infections or

who have undergone recent immunization and who have high titre of

a particular antibody

▪ Plasma containing antibodies against hepatitis B and HIV or

any plasma capable of transmitting infections to recipient are

excluded

o The immunoglobulins are presented as freeze dried or liquid

preparation at suitable concentration (10-20 times higher than

that in the plasma)

o Glycine may be added as a stabilizer and thiomersal as a

preservative

STEP 4: Classes of vaccines and Sera (40 minutes)

• Vaccines can be classified into two broad groups;

o Vaccines containing killed or inactivated pathogens

o Vaccines containing live or attenuated pathogens

• Vaccines containing live or attenuated pathogens

o Live vaccines

▪ Live vaccines are made up of live bacteria, viruses, or other

agents which when administered by appropriate route cause

subclinical or mild infections

▪ In the course of such infection the antigenic components in

the vaccine evoke an immune response which provide protection

against the more serious natural disease

o Attenuated vaccines

▪ Attenuated vaccines are vaccines containing pathogens

manipulated in the laboratory to produce strain of the pathogen

with reduced virulence

• Attenuation can be attained by mutant strain polio virus,

consecutive passage through an anima which is not a host

of the pathogen e.g. small pox vaccine passage in calf and

passage through a series of cultures e.g. rabies virus in

human cell culture

▪ The attenuated organisms multiply in the host and provoke and

immune response

o Examples of live vaccines include Bacille Calmette-Guerin (BCG),

oral polio vaccine, yellow fever vaccine, measles vaccine etc.

o Advantages of live vaccines include;

▪ Single dose is often enough
▪ Produce strong immunity

o Disadvantage of live vaccines

▪ The organism may cause full fledge infection
• Vaccines containing killed or inactivated pathogens (Inactivated

vaccines)

o These vaccines do not replicate as the pathogens are killed or

only their components are present in the vaccines

o They require adjuvants to enhance immunogenicity

o They are toxic and thus require multiple doses

o Most viral vaccines are killed or inactivated

o Killed vaccines

▪ Killed vaccines are suspensions of whole bacteria, viruses or

other pathogenic agents that have been killed by heat or by

disinfectants such as phenol or formaldehyde

▪ The killed organisms cannot replicate to cause infection
▪ Because all the components of the microorganisms are present

in the vaccine, the vaccine may be toxic to the body

▪ Therefore, killed vaccines are usually divided into initial

and booster doses give at regular intervals of time

▪ Killed vaccines include polio vaccine, pertussis vaccine,

influenza vaccine, and rabies vaccine

o Toxoid vaccines

▪ Toxoids are preparations derived from the toxins that are

secreted by certain species of bacteria

▪ The toxin from the bacteria is treated with formadehyde to

eliminate toxicity but retaining its immunogenicity

▪ The process of converting a toxin to a toxoid is called

Toxoiding and the end product is the toxoid

▪ Toxoid vaccines include Tetanus vaccine (Tetanus Toxoid or

TT), and Diphtheria toxoid

o Cell Component or Subunit vaccines

▪ These are vaccines produced from purified protective

components

• This avoids the undesirable reactions due to whole

vaccines

▪ Immune reaction is produced only to the components or

subunits contained in the vaccine

• The response is more specific compared to that produced to

whole vaccines

▪ Cell component vaccines include Haemophilus influenzae type b

vaccine, hepatitis B vaccine etc

• Immune sera (or antisera) are grouped into two types

o Antitoxins

▪ These neutralize toxins produced by specific bacteria but

does not kill the bacteria

o Antimicrobial sera

▪ They act to kill (destroy) the bacteria by making them more

susceptible to leukocyte action

o Injection with these antisera provide temporary or passive

immunity against a specific disease and is used when a person has

already been exposed to or has contracted the disease

o Diseases where passive immunization is used include diphtheria,

tetanus, botulism and gas gangrene

STEP 5: Composition of vaccines and Sera (30 minutes)

• Vaccines differ in their composition, efficacy and duration of

effective protection to the vaccinated individuals

• The components are;

o The chief ingredient in all vaccines is the active ingredient

▪ This is the part that challenges the immune system so that it

produces immunity that can fight the disease

▪ This is the antigentic component of the vaccine
▪ Example of antigenic components of vaccines and sera are
• pathogen (live, attenuated, killed or its component) for

the case of vaccine

• Immunoglobulin/antibodies for the case of immune sera

o Adjuvant is another component of a vaccine

▪ Adjuvants are heterogenous collection of substances which

enhances the immune response

▪ Adjuvants used in human vaccines include;
• Aluminium hydroxide gel (hydrated aluminium oxide)
• Aluminium phosphate

o Water

▪ Sterile water is used as a vehicle

o Preservatives

▪ These are used to prevent growth of contaminating

microorganisms

▪ They are used in very small
▪ Common preservatives in vaccine is thiomersal

o Stabilizers

▪ Are used to stabilize the vaccine for example against effects

of temperature

▪ Examples of a stabilizer used in vaccine is gelatine,

sorbitol, sucrose, lactose etc.

STEP 6: Key Points (5 minutes)

• Immunological preparations are preparations that modify the immune

system

• Vaccines contain antigens that stimulate the immune system of the

recipient to produce T-cells or antibodies that attack and destroy the

infectious agent

• Vaccines differ in their composition, efficacy and duration of

effective protection to the vaccinated individuals

• The sera contain antibodies against specific disease and used to

provide passive immunity to that diseases. Sera do not stimulate

production of antibodies

• Antitoxins neutralize toxins produced by specific bacteria but does

not kill the bacteria

STEP 7: Evaluation (5 minutes)

• What is an attenuated vaccine?
• What is an antiserum?
• What is the clinical use of immune sera?

References

Hugo and Russell (2011), Pharmaceutical Microbiology 8th Edition, Willey-

Blackwel publications

Karen C. Carroll et al (2013); Jawetz, Melnick and Adelberg’s Medical

Microbiology 26th Ed. McGraw Hill Co. Inc.

Greenwood et al (2012); Medical Microbiology, 18th edition Churchill

Livingstone

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