IMMUNOBIOLOGICALS Flashcards by Cherie Rosemarie Balorio

are biological preparations used to stimulate the immune system against diseases.

Vaccines

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Your body produces antibodies after being exposed to an infection or receiving a vaccine

Active Immunity

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You receive antibodies from an external source, like from your mother or through medicine.

Passive Immunity

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Antibodies made after exposure to an infection

Active immunity: Natural

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Antibodies made after getting vaccination

Active Immunity: Artificial

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Antibodies transmitted from mother to baby ( e.g.,via mother’s milk)

Passive Immunity: Natural

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Antibodies acquired from an immune serum medicine

Passive Immunity: Artificial

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• A preparation that is used to stimulate the body’s immune response against diseases.
• Usually administered through needle injections, but some can be administered by mouth or sprayed into the nose.

Vaccines

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denotes the physical act of administering a vaccine or toxoid

Vaccination

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An emperor documented his practice of variolation, or inoculation, of his troops and his own children with smallpox to confer protection from the disease

K’ang of China ( 17th century)

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Involved taking liquid from a smallpox pustule of an
infected patient, cutting the skin of an uninfected person, and then introducing the inoculum

Variation

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She observed and introduced variolation during her time in Constantinople (1716–1718).

Lady Mary Montagu

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Promoted variolation in America

Cotton Mather and Dr. Zabdiel Boylston

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• Developed the first vaccine using cowpox
• Coining the term “vaccination” from vacca (Latin for “cow”), improving vaccine safety.

Edward Jenner (1796)

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Categories of Vaccine

• Prophylactic Vaccine
• Therapeutic Vaccine

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• Preventative vaccine
• Involves introducing antigens into a person’s body.
• The goal is that the individual’s immune system will create antibodies for those antigens, and become immune to the associated illness.

Prophylactic Vaccines

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Used to treat existing diseases, including cancer and chronic infections.

Therapeutic Vaccines

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(6) Vaccine types

• Live Attenuated
• Inactivated
• Subunit Vaccines, Surface Protein Subunit Vaccines, Polysaccharides
• Toxoids
• DNA Vaccines, Recombinant Vectors
• mRNA Vaccines

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• Use a weakened form of a virus that
contains antigens that appropriately stimulate an immune response.
• Such viruses have been passaged to reduce their virulence but retain immunogenic antigens that elicit strong humoral and cellular responses and the development of memory cells after one or two
doses.

Key Problems
• the vaccine cannot be used if the patient is immunocompromised, has fever or malignancy, or is taking immunosuppressive drugs
• should not be used in pregnancy

Live Attenuated Vaccines

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• Killing pathogens by heat, radiation, or chemicals to inactivate them generates the antigenic starting materials.
• The dead pathogens can no longer replicate or mutate to their disease-causing state and thus are safe.
• These types of vaccines are useful because they can be freeze-dried and transported without refrigeration, an important consideration in reaching developing countries.

Key Problems

• If the vaccine is not totally inactivated - disease can result
• if the preparation is overtreated - vaccine failure usually results due to denaturation
• the production laboratory must grow the pathogen in large quantities to be commercially useful - putting laboratory technicians at risk
• the patient may experience abnormal and harmful responses

Inactivated Vaccines

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• As with inactivated vaccines, subunit vaccines do not contain live pathogens; rather, subunit vaccines use a component of the microorganism as a vaccine antigen to mimic exposure to the
organism itself.
• Subunit vaccines typically contain polysaccharides or proteins (surface proteins or toxoids).
• Compared to live attenuated vaccines, subunit vaccines induce a less-robust immune response.

Key Problems
• weaker immune response, may require adjuvants

Subunit Vaccines

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• Pathogenic bacteria such as Clostridium tetani and Corynebacterium diphtheriae induce disease (tetanus or diphtheria, respectively) through production of their toxins.
• Vaccines against these toxins, known as toxoid vaccines, are effective because they elicit an immune response that results in the production of toxin-specific neutralizing antibodies, preventing cell damage in the patient.
• They are typically produced by formaldehyde treatment of the
toxin They are safe and unquestionably efficacious

Toxoid Vaccines

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• Sequencing the genome of a pathogen provides information that enables the production of a DNA vaccine against selected genetic material.
• A microbe’s antigenic genes are selected and incorporated in synthetic DNA.

DNA Vaccines

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• One of the barriers to effectiveness of DNA vaccines is that the nucleic acids must not only be delivered into the cytoplasm of cells but also achieve nuclear import to localize with host cell DNA polymerases to produce messenger RNA (mRNA).

mRNA Vaccines

Types of Vaccine Preperation

• Simple Vaccine • Multivalent Vaccine • Polyvalent Vaccine

contains one strain of a disease-causing organism (e.g., plague vaccine, Pasteurella pestis, and smallpox vaccine).

Simple Vaccine

is prepared from two or more strains of an organism that cause the same disease (e.g., polio is trivalent).

Multivalent Vaccine

refers to vaccines containing multiple antigens for broader immunity.

Polyvalent Vaccine

Types of Dosing

• Single-dose Vaccine • Multiple-dosing Regimen • Booster Dose • Coadministered Vaccine

is usually assumed to confer, with one shot, “lifetime immunity.” The smallpox vaccine was a single- dose vaccine.

Single-dose vaccine

• Several doses are given, spaced weeks or months apart, to get maximum immunogenicity. • Multiple dosing is usually done with inactivated vaccines, which are less antigenic. Multiple dosing is not the same as a booster dose.

Multiple-dosing regimen

• is administered years after the initial immunization schedule (regardless of single or multiple first dose). • As a patient ages, Ab levels may wane. A booster is used to bolster immunity. • Also used if a patient is known or suspected to have been exposed to a pathogen (e.g., tetanus).

Booster dose

• An ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better. • help the body to produce an immune response strong enough to protect the person from the disease he or she is being vaccinated against.

Adjuvants

can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.

Adjuvanted Vaccines

(4) Aluminum

• Amorphous aluminum hydroxyphosphate sulfate (AAHS) • Aluminum hydroxide • Aluminum phosphate • Potassium Aluminum sulfate (Alum).

destroys live viral and bacterial vaccines. If the agent is not killed, the antigen may be altered

Heat

formed inside the protein structure during freeze-drying expand during thawing and disrupt the structure of the vaccine.

Ice Crystals

(6) Proper Vaccine Storage

• Freezing Compartment • Top Shelf • Middle Shelf • Lower Shelf • Door Storage • Dial Thermometer

Stores Oral Polio Vaccine (OPV) vials.

Freezing Compartment

Stores Bacillus Calmette–Guérin (BCG) for tuberculosis, Measles, MMR, and Varicella vaccines.

Top Shelf

Stores Hepatitis A, Typhoid, and Hepatitis B vaccines.

Middle Shelf

Stores DPT, DT, TT, and DTaP vaccines.

Lower Shelf

Should remain empty to avoid temperature fluctuations.

Door Storage

Placed on the top shelf to monitor temperature.

Dial Thermometer

(6) Components of Vaccines

• Active Ingredients • Adjuvants • Antibiotics • Stabilizers • Preservatives • Trace Components

Viral or bacterial antigens that stimulate the immune system.

Active Ingredients

Enhance immune response (e.g., aluminum-based compounds).

Adjuvants

Prevent bacterial contamination during manufacturing.

Antibiotics

Maintain vaccine stability during storage (e.g., sugar, gelatin)

Stabilizers

Prevent bacterial and fungal growth in multi-dose vials (e.g., thimerosal).

Preservatives

Residual materials from the production process (e.g., formaldehyde).

Trace Components

• Is a live ‘vaccinia’ (cowpox) virus grown on the skin of a bovine calf • There have been no reported cases of smallpox since the 1940s.) • In 1982, smallpox was declared eradicated worldwide. • With smallpox, the risks of the vaccine outweigh the benefits • The vaccine penetrates the central nervous system and potentially fatal encephalitis.

SMALLPOX VACCINE (DRYVAX)

• Influenza vaccine is a multivalent inactivated influenza virus or viral subunits (split vaccine). • The virus is grown on chick embryo and inactivated by exposure to ultraviolet (UV) light or formaldehyde.

INFLUENZA VACCINE13–17

• Persons 65 years of age or older • Residents of nursing homes and other chronic- care facilities that house persons of any age who have chronic medical conditions • Adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma. • Children and teenagers (aged 6 months–18 years) who are receiving long-term aspirin therapy. (Reyes Syndrome) • Pregnant women who are at second or third trimester

High risk of Influenza

• Is a dangerous viral infection that affects both muscle mass and the spinal cord causing paralysis, and may die because of respiratory paralysis. • Was the cause of the “infantile paralysis” epidemic of 1950 to 1953, which led to many paralyzed children and the specter of patients spending their lives in an iron lung. • The symptoms may reappear 40 to 50 years after a severe infection. • This phenomenon is known as Postpolio Muscle Atrophy (PPMA). • PPMA is not a reinfection or reactivation of the virus but is probably a form of rapid aging in polio survivors.

POLIO

2 types of polio vaccines:

1. Inactivated Polio Vaccine (IPV) 2. Trivalent Oral Polio Vaccine (TOPV)

• Synonyms for the IPV vaccine: IPV, e-IPV, ep-IPV, and the Salk vaccine (1954 [IPOL, Aventis Pasteur]). • IPV is a trivalent (strains 1, 2, 3) vaccine grown in monkey kidney culture and subjected to elaborate precautions to ensure inactivation (typically, formaldehyde is used). • e-IPV is recommended for routine use in all four immuniz- ing doses in infants and children.

Inactivated Polio Vaccine (IPV)

• Sabin vaccine (1960) • Is a live attenuated whole virus vaccine (antigen type, protein) containing strains 1, 2, and 3. • The virus culture is grown on monkey kidney tissue with the use of an elaborate attenuation protocol. • A major caution with TOPV is that it is a live vaccine and must never be injected. • The WHO has advocated giving children e-IPV instead of TOPV to prevent

Trivalent Oral Polio Vaccine (TOPV)

• “3- day measles” • It is a mild disease with few consequences, except in the first trimester of pregnancy. • It is a live, attenuated rubella virus produced in human diploid cell culture. • The antigen form of the vaccine is whole virus CAUTION: • The vaccine should not be administered in pregnancy and should always be administered with great care to women of childbearing age. • Because measles vaccine is cultivated in egg medium, care must be used in patients who are allergic to eggs and egg products. For this reason, a test dose regimen is used.

Rubella Vaccine 23 (German measles vaccine, live, Meruvax II, Merck)

•It causes fever, headache, and a painful swelling of the parotid glands under the jaw. • It can be serious and is highly contagious. • Prior to the vaccine, the disease was passed from child to child with ease. • Its vaccine (Mumpsvax, Merck) is a live, attenuated virus grown on chick embryo culture with attenuation protocols. The antigen form is whole virus. CAUTION: • Because mumps vaccine is cultivated in egg medium, care used to be advised in patients allergic to eggs and egg products. • Recent data show that persons who are allergic to egg and egg products fail to react to the mumps vaccine.

MUMPS VACCINE

• Examples of polyvalent viral vaccines are measles–rubella (MR), rubella–mumps (RM), and MMR. MMR is indicated for routine immunization at 15 months (not given at 1 year unless the child has been exposed or lacks immunocompetence). • This is because maternal Abs interfere with development of vaccine immunity in small children. If the MMR is given at less than 1 year, revaccination is needed at 15

COMBINATION PRODUCTS (POLYVALENT VIRAL VACCINES)

• _________ Caused by varicella-zoster virus. • The disease is usually benign but can lead to bacterial superinfection, pneumonia, encephalitis, and Reye’s syndrome. •_______ (Varivax, Merck) is derived from live virus from a child with natural varicella. • The virus has been attenuated by passage through a series of guinea pig and human cell cultures.

Chickenpox/ Varicella Vaccine

• Is a complex of diseases that causes fever, nausea, abdominal pain, jaundice, liver failure, and death. • There are five clinically recognized types (A, B, C, D, and E).

HEPATITIS VACCINES

• HAV; an infectious hepatitis • Causes an acute disease with an abrupt onset. • An injection of hepatitis __ immune globulin is one way of preventing the disease but is only effective for about 30 days. • The hepatitis __ vaccine (Havrix) is an inactivated preparation that is produced by propagation of the virus in cultured human diploid cells and then is inactivated with formalin. • The course of immunization involves two injections over a 4-week period and a booster 12 months after the first injection.

HEPATITIS A VACCINE

• HBV; the cause of serum hepatitis • Is a much more insidious, chronic disease, transmitted by needles, mucosal contact, blood, or high-risk sexual activity. • The hepatitis __ vaccine was first introduced in 1981. • Initially, it was prepared as an inactivated vaccine from the plasma of carefully screened human, hightiter carriers/donors. • In 1986, the recombinant DNA (rDNA) vaccine (Engerix B, Recombivax) was introduced to the market.

HEPATITIS B VACCINE

• HCV was once called “hepatitis non-A, non-B” but has been recognized as a separate entity. • Administration of interferon alpha (IFN-) during the early acute phase can cure most patients. • Unfortunately, 50% to 60% of those with HCV infection develop chronic hepatitis.

HEPATITIS C VACCINE

• Is a sexually transmitted virus. • There are many varieties of HPV. Not all of them cause health problems. • Some strains of this cause genital warts or cervical cancer. • Has types 16 and 18 cause approximately 70% of cervical cancers. • HPV types 6 and 11 cause approximately 90% of genital warts. • There is no cure for the virus itself. • There are treatments for genital warts, cervical changes, and cervical cancers. • In a patient with genital warts, even if treated, the virus may still be present and may be passed onto sex partners. present and may be passed onto sex partners.

HUMAN PAPILLOMAVIRUS (HPV)

• Gardasil is between 95% and 100% efficacious against HPV types 6, 11, 16, and 18. • The vaccine is given in a three-shot regimen after the first injection. • The second injection is given 2 months later, and followed by a third injection 6 months after the first injection. • The vaccine will not treat or cure HPV. • It may help people who have one type of HPV from being infected with other types.

HUMAN PAPILLOMAVIRUS (HPV) VACCINE

• Pertussis, also known as whooping cough, is a highly communicable infection caused by B.pertussis. • B. pertussis produces an endotoxin that causes a spectrum of symptoms in a host. • Pertussis occurs mainly in children, and there is no effective treatment once the disease becomes manifest. • In 1992, a new vaccine was developed that consists of bacterial fractions,combined with tetanus and diphtheria toxoids. • This vaccine, called Acell-Immune, or diphtheria–tetanus– • Acellular pertussis (DTaP), is safe and highly effective and has been added to the routine immunization schedule. • The vaccine is adsorbed and is used for routine immunization as the polyvalent preparation diphtheria–tetanus–pertussis (DTP) (at 2, 4, 6, and

PERTUSSIS VACCINE

• For young children • 2,4,6 mos. • 15 through 8 mos. • 4 through 6 yrs

DTap

• For Preteens/Pregnant women/Adults • 11-12 yrs (preteens) • During the 27th-36th week of each pregnancy (pregnant) • Anytime for those who haven never receives a vac (adult)

Tdap

• Hib causes the most common type of bacterial meningitis and is a major cause of systemic disease in children younger than 6 years old. • It has approximately a 10% mortality • Hib-CV is a sterile, lyophilized capsular polysaccharide from Hib vaccine, conjugated to various protein fragments. • The antigen type is polysaccharide

HAEMOPHILUS INFLUENZA TYPE B CONJUGATE VACCINE

• Is a serious disease caused by Mycobacterium tuberculosis. • The vaccine is referred to as the bacillus Calmette-Guérin (BCG) vaccine • It is a live/attenuated strain of Mycobacterium bovis. • The antigenic form is the whole bacterium, and the antigen type is protein. • BCG is a live vaccine, so it cannot be administered to immunosuppressed patients, burn patients, or pregnant women unless exposed (and even then not in the first trimester). • An adverse effect of the BCG vaccine includes a positive TB skin test. • A red blister forms within 7 to 10 days, then ulcerates and scars within 6

TUBERCULOSIS VACCINE

• Is a disease caused by Vibrio cholerae that presents as severe, watery diarrhea caused by an enterotoxin secreted by the 01-serotype of V. cholerae. • The vaccine consists of whole cells of V. cholerae 01 that have been inactivated. • The antigen form of the vaccine is whole bacterium, and the antigen type is protein toxin and lipopolysaccharide.

CHOLERA VACCINE

• Is an inactivated vaccine composed of capsular polysaccharide fragments of Neisseria meningitidis. • There are four polysaccharide serotypes represented in the vaccine: A, C, Y, and W-135. • The type A polysaccharide consists of a polymer of N-acetyl-O-mannosamine phosphate • The group C polysaccharide is mostly N-acetyl- Oacetylneuraminic acid.

MENINGOCOCCAL POLYSACCHARIDE VACCINE

• Also known as “cus”. • The microorganism protects itself from the immune system by producing a capsular polysaccharide that is highly antigenic. • This polysaccharide is used to prepare the vaccine

PNEUMOCOCCAL VACCINE

• Is a disease that is also known as lockjaw. The organism in the toxoid, adsorbed tetanus toxoid (T, adsorbed), is designated inactivated. • The antigen form is toxoid, and the antigen type is protein. • This toxoid lasts approximately 10 years. • A booster is recommended if injured or every 5 years.

ADSORBED TETANUS TOXOID (TETANUS)

• A class of therapies that can induce a dynamic immune response that, in theory, can continue to adapt and expand following initiation of vaccination. • This adaptability, through epitope spreading or antigen cascade, can continuously refine a therapeutic immune response, making it more relevant to the patient’s tumor. • Therapeutic vaccines, expressing specific endogenous or exogenous antigens, mainly induce or boost cell-mediated immunity via provoking cytotoxic T cells or elicit humoral immunity via activating B cells to produce specific antibodies. • The ultimate aim of a therapeutic vaccine is to reshape the host immunity for eradicating a disease and establishing lasting memory. • Have been developed for the treatment of some infectious diseases and chronic noncommunicable diseases.

THERAPEUTIC VACCINE

Vaccine for Cancer

• Tice (Bacillus Calmette-Guerin) • Provenge (sipuleucel-T) • Imlygic (talimogene laherparepvec) • Canvaxin • GVAX • TroVax

A live-attenuated vaccine approved in 1990 for the treatment of carcinoma in situ of the bladder

Tice (Bacillus Calmette-Guerin)

A dendritic cell-based vaccine approved in 2010 that is used for the treatment of metastatic, hormone-resistant prostate cancer

Provenge (sipuleucel-T)

A live-attenuated vaccine approved in 2015 that is indicated for the treatment of advanced oncolytic melanoma (a type of skin cancer)

Imlygic (talimogene laherparepvec)

an allogeneic vaccine for invasive bladder cancer

Canvaxin

a whole-tumor cell vaccine for pancreatic ductal adenocarcinoma

GVAX

an antigenic vaccine for renal cell carcinoma (a type of kidney cancer)

TroVax

Human Papillomavirus (HPV)

• Candin • Hespecta • SLP-HPV-01

a synthetic vaccine used to treat pre-malignant tumors in HIV-positive men with anal cancer

SLP-HPV-01

a vaccine candidate used to treat tumors caused by HPV 16 (a high-risk strain of the virus)

Hespecta

Vaccine for Herpes Simplex Virus

• HSV529 • Delta gD-2l • GSK4108771A

a novel vaccine that uses messenger RNA (mRNA)—the same technology that enabled the development of the Moderna and Pfizer COVID-19 vaccines

GSK4108771A

a vaccine that utilizes a genetically altered herpes virus

Delta gD-2

vaccine that uses a replication-defective virus that can induce a stable antibody response without causing disease

HSV529

Vaccine for Hepatitis B

• GS-4774 • HBsAg-HBIG • HBsAg/HBcAg,

an antigen vaccine that includes yeast-based adjuvant (a substance that induces a more robust immune response)

GS-4774,

another antigen vaccine that contains an aluminum-based adjuvant to

HBsAg-HBIG

an antigen vaccine that combines two different hepatitis antigens (one from the surface of the virus and one from the core)

HBsAg/HBcAg

• a product derived from blood plasma from a donor pool similar to the Ig pool but prepared so it is suitable for intravenous use. • used for replacement therapy in primary Ab deficiency disorders and for the treatment of Kawasaki disease, • immune thrombocytopenia purpura, hypogammaglobulinemia in chronic lymphocytic le kemia and some cases of HIV infection

Intravenous Immune Globulin

• specialized preparations obtained from blood plasma from donor pools preselected for a high Ab content against a specific antigen EXAMPLE: hepatitis b immune globulin, varicella- zoster immune globulin (VZIG)

Specific Immune Globulin

IMMUNOBIOLOGICALS Flashcards

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