Podcast
Questions and Answers
What is a key consideration in modern vaccine design and development?
What is a key consideration in modern vaccine design and development?
- Excluding adjuvants to minimize allergic reactions.
- Evolving designs to address various factors and improve effectiveness. (correct)
- Focusing solely on live-attenuated virus vaccines.
- Ignoring the clinical trial phases to expedite vaccine availability.
Which type of immunity involves the transfer of antibodies from mother to baby through breast milk?
Which type of immunity involves the transfer of antibodies from mother to baby through breast milk?
- Artificial active immunity
- Natural passive immunity (correct)
- Natural active immunity
- Artificial passive immunity
What was the primary benefit of variolation?
What was the primary benefit of variolation?
- Eliminating the need for future vaccinations.
- Protecting individuals from developing smallpox infections. (correct)
- Eradicating smallpox completely.
- Causing a more severe form of smallpox.
What is a common concern among individuals who oppose vaccinations?
What is a common concern among individuals who oppose vaccinations?
How does herd immunity primarily protect populations from disease?
How does herd immunity primarily protect populations from disease?
Which of the following is NOT a type of vaccine formulation?
Which of the following is NOT a type of vaccine formulation?
What type of immune response are vaccine formulations designed to generate?
What type of immune response are vaccine formulations designed to generate?
What is the main purpose of adjuvants in vaccines?
What is the main purpose of adjuvants in vaccines?
Which of the following best describes the purpose of Phase I clinical trials for vaccines?
Which of the following best describes the purpose of Phase I clinical trials for vaccines?
Under what circumstances can a company apply for Emergency Use Authorization (EUA) for a vaccine in the U.S.?
Under what circumstances can a company apply for Emergency Use Authorization (EUA) for a vaccine in the U.S.?
What is the purpose of Phase IV (post-marketing surveillance) in vaccine development?
What is the purpose of Phase IV (post-marketing surveillance) in vaccine development?
What is the Vaccine Adverse Event Reporting System (VAERS)?
What is the Vaccine Adverse Event Reporting System (VAERS)?
How does artificial active immunity differ from natural active immunity?
How does artificial active immunity differ from natural active immunity?
Which of the following statements about passive immunity is most accurate?
Which of the following statements about passive immunity is most accurate?
What is the primary mechanism of action for Regeneron anti-spike protein antibodies?
What is the primary mechanism of action for Regeneron anti-spike protein antibodies?
What is the term for the death rate due to a disease?
What is the term for the death rate due to a disease?
What is the difference between an epidemic and a pandemic?
What is the difference between an epidemic and a pandemic?
Edward Jenner is best known for his work related to which disease?
Edward Jenner is best known for his work related to which disease?
According to the information, what is one of the primary reasons some parents may delay or refuse vaccines for their children?
According to the information, what is one of the primary reasons some parents may delay or refuse vaccines for their children?
What is a common misconception regarding vaccine ingredients?
What is a common misconception regarding vaccine ingredients?
Which of the following statements is true regarding thimerosal?
Which of the following statements is true regarding thimerosal?
What role does formaldehyde play in vaccine manufacturing?
What role does formaldehyde play in vaccine manufacturing?
What is the average daily intake of aluminum for a person?
What is the average daily intake of aluminum for a person?
What is a potential explanation for why some might incorrectly believe that general health measures are sufficient, rather than vaccines?
What is a potential explanation for why some might incorrectly believe that general health measures are sufficient, rather than vaccines?
What is the primary role of stabilizers in vaccines?
What is the primary role of stabilizers in vaccines?
Why are some vaccines administered in multiple doses?
Why are some vaccines administered in multiple doses?
What is a significant advantage of live-attenuated vaccines compared to non-live vaccines?
What is a significant advantage of live-attenuated vaccines compared to non-live vaccines?
What is the primary risk associated with live-attenuated vaccines?
What is the primary risk associated with live-attenuated vaccines?
What is a key characteristic of non-live vaccines?
What is a key characteristic of non-live vaccines?
What is a key advantage of non-live vaccines?
What is a key advantage of non-live vaccines?
Which type of vaccine uses a weakened form of the virus or bacteria that causes a disease?
Which type of vaccine uses a weakened form of the virus or bacteria that causes a disease?
If a vaccine uses a killed (inactivated) virus, what is a common characteristic of how it works compared to a live vaccine?
If a vaccine uses a killed (inactivated) virus, what is a common characteristic of how it works compared to a live vaccine?
A vaccine that contains parts of a virus or bacteria, rather than the entire microbe, is called a what?
A vaccine that contains parts of a virus or bacteria, rather than the entire microbe, is called a what?
If a vaccine contains a toxoid, what type of disease is it designed to prevent?
If a vaccine contains a toxoid, what type of disease is it designed to prevent?
What is primarily responsible for slow immune response (mainly Ig production) in inactivated or killed vaccines?
What is primarily responsible for slow immune response (mainly Ig production) in inactivated or killed vaccines?
What is the purpose of using an attenuated pathogen as a vector in vectored vaccines?
What is the purpose of using an attenuated pathogen as a vector in vectored vaccines?
What is a limitation of DNA vaccines compared to traditional vaccines?
What is a limitation of DNA vaccines compared to traditional vaccines?
What is the function of the antigen-encoding mRNA in mRNA vaccines?
What is the function of the antigen-encoding mRNA in mRNA vaccines?
What is a major challenge in delivering mRNA effectively for vaccination?
What is a major challenge in delivering mRNA effectively for vaccination?
What is the benefit of lipid encapsulation of mRNA in mRNA vaccines?
What is the benefit of lipid encapsulation of mRNA in mRNA vaccines?
ACE2 (angiotensin-converting enzyme 2) does NOT have a role in?
ACE2 (angiotensin-converting enzyme 2) does NOT have a role in?
Besides Aluminum, which of these can serve as an adjuvant for minimal immunogenic Ags?
Besides Aluminum, which of these can serve as an adjuvant for minimal immunogenic Ags?
Considering the evolution of vaccine design, what is the most critical attribute that differentiates contemporary vaccine strategies from those employed in the era of variolation?
Considering the evolution of vaccine design, what is the most critical attribute that differentiates contemporary vaccine strategies from those employed in the era of variolation?
In the context of vaccine clinical trials, under what highly specific regulatory circumstance would a company be permitted to bypass traditional Phase III efficacy trials and seek initial approval via Emergency Use Authorization (EUA)?
In the context of vaccine clinical trials, under what highly specific regulatory circumstance would a company be permitted to bypass traditional Phase III efficacy trials and seek initial approval via Emergency Use Authorization (EUA)?
Given the multifactorial nature of vaccine hesitancy, which of the following approaches would be least effective in addressing parental concerns regarding vaccine safety and promoting informed decision-making?
Given the multifactorial nature of vaccine hesitancy, which of the following approaches would be least effective in addressing parental concerns regarding vaccine safety and promoting informed decision-making?
Considering the known limitations of inactivated vaccines, what is the most critical immunological challenge that necessitates the incorporation of potent adjuvants or the administration of multiple doses?
Considering the known limitations of inactivated vaccines, what is the most critical immunological challenge that necessitates the incorporation of potent adjuvants or the administration of multiple doses?
When considering the limitations of live-attenuated vaccines, what represents the most significant obstacle precluding the use of such vaccines in specific patient populations?
When considering the limitations of live-attenuated vaccines, what represents the most significant obstacle precluding the use of such vaccines in specific patient populations?
Given the established role of adjuvants in enhancing vaccine immunogenicity, what is the most precise mechanism by which aluminum salt adjuvants, such as alum, potentiate the immune response?
Given the established role of adjuvants in enhancing vaccine immunogenicity, what is the most precise mechanism by which aluminum salt adjuvants, such as alum, potentiate the immune response?
In the development of mRNA vaccines, what presents the foremost challenge in ensuring effective translation of the antigen-encoding mRNA within the host cell cytoplasm:
In the development of mRNA vaccines, what presents the foremost challenge in ensuring effective translation of the antigen-encoding mRNA within the host cell cytoplasm:
Considering the principles underlying vectored vaccines, what mechanism fundamentally accounts for the enhanced immunogenicity observed when using a replication-competent viral vector?
Considering the principles underlying vectored vaccines, what mechanism fundamentally accounts for the enhanced immunogenicity observed when using a replication-competent viral vector?
When formulating hypotheses regarding correlates of protection for a novel vaccine, what constitutes the most critical determinant in predicting long-term efficacy against a pathogen characterized by high antigenic variability?
When formulating hypotheses regarding correlates of protection for a novel vaccine, what constitutes the most critical determinant in predicting long-term efficacy against a pathogen characterized by high antigenic variability?
Given the challenges associated with achieving mucosal immunity through systemic vaccination, what represents the most plausible strategy for eliciting robust and durable protection against pathogens that primarily infect via mucosal surfaces?
Given the challenges associated with achieving mucosal immunity through systemic vaccination, what represents the most plausible strategy for eliciting robust and durable protection against pathogens that primarily infect via mucosal surfaces?
When considering the influence of host genetics on vaccine responses, which factor would most significantly impact the magnitude and quality of CD8+ T cell responses following vaccination?
When considering the influence of host genetics on vaccine responses, which factor would most significantly impact the magnitude and quality of CD8+ T cell responses following vaccination?
Among the various methods used to inactivate whole-pathogen vaccines, which approach would be least likely to preserve the immunogenic epitopes necessary for eliciting broadly neutralizing antibodies?
Among the various methods used to inactivate whole-pathogen vaccines, which approach would be least likely to preserve the immunogenic epitopes necessary for eliciting broadly neutralizing antibodies?
What immunological mechanism would be LEAST effective in combatting a pathogen that exhibits significant antigenic drift?
What immunological mechanism would be LEAST effective in combatting a pathogen that exhibits significant antigenic drift?
In the context of vaccine development for emerging viral threats, what strategy would be LEAST effective as a primary countermeasure against a virus exhibiting high rates of recombination and reassortment?
In the context of vaccine development for emerging viral threats, what strategy would be LEAST effective as a primary countermeasure against a virus exhibiting high rates of recombination and reassortment?
What is the primary challenge in formulating effective vaccines against intracellular bacterial pathogens?
What is the primary challenge in formulating effective vaccines against intracellular bacterial pathogens?
What is a critical factor in the success of conjugate vaccines?
What is a critical factor in the success of conjugate vaccines?
Why do certain vaccines require administration via the intramuscular route?
Why do certain vaccines require administration via the intramuscular route?
For an emerging viral variant with mutations primarily affecting antibody epitopes, which vaccine design strategy provides the most promising approach to broad and durable protection?
For an emerging viral variant with mutations primarily affecting antibody epitopes, which vaccine design strategy provides the most promising approach to broad and durable protection?
What is the MOST relevant translational consideration when transitioning from promising preclinical vaccine data to human clinical trials?
What is the MOST relevant translational consideration when transitioning from promising preclinical vaccine data to human clinical trials?
What is the foremost challenge to formulating effective vaccines against highly mutable viruses characterized by frequent antigenic drift?
What is the foremost challenge to formulating effective vaccines against highly mutable viruses characterized by frequent antigenic drift?
In the development of a novel subunit vaccine, what is the most crucial consideration when selecting an appropriate adjuvant?
In the development of a novel subunit vaccine, what is the most crucial consideration when selecting an appropriate adjuvant?
Which innate immune pathway is LEAST likely to be activated by mRNA based vaccines?
Which innate immune pathway is LEAST likely to be activated by mRNA based vaccines?
If a patient has known mutations in genes encoding proteins involved in innate immunity, how should this MOST influence your vaccine selection?
If a patient has known mutations in genes encoding proteins involved in innate immunity, how should this MOST influence your vaccine selection?
In the formulation of multivalent vaccines, what is MOST critical?
In the formulation of multivalent vaccines, what is MOST critical?
When faced with a novel, highly pathogenic virus, what is the LEAST useful immediate step?
When faced with a novel, highly pathogenic virus, what is the LEAST useful immediate step?
Why are multiple vaccine doses MOST critical.
Why are multiple vaccine doses MOST critical.
When considering vaccine strategies for elderly individuals, what is MOST concerning?
When considering vaccine strategies for elderly individuals, what is MOST concerning?
When considering a protein subunit vaccine, what is the MOST important aspect to test in Phase I clinical trials?
When considering a protein subunit vaccine, what is the MOST important aspect to test in Phase I clinical trials?
What is the chief reason that public health initiatives, on their own, are unable to eradicate a disease that is vaccine preventable?
What is the chief reason that public health initiatives, on their own, are unable to eradicate a disease that is vaccine preventable?
What is the MOST likely reason for vaccine failure?
What is the MOST likely reason for vaccine failure?
What is the MOST compelling reason to get vaccinated?
What is the MOST compelling reason to get vaccinated?
Under what circumstances should a physician delay vaccination?
Under what circumstances should a physician delay vaccination?
In a population with significant vaccine dissent, what is the the LEAST helpful thing to do?
In a population with significant vaccine dissent, what is the the LEAST helpful thing to do?
A medical device company has a technology that can perform continuous measurements of neutralizing antibody titers against a respiratory virus. How should this technology be BEST used for a vaccine development project?
A medical device company has a technology that can perform continuous measurements of neutralizing antibody titers against a respiratory virus. How should this technology be BEST used for a vaccine development project?
A trial is enrolling patients, but most of hte patients are immunologically naive. What is MOST urgent to add to the study?
A trial is enrolling patients, but most of hte patients are immunologically naive. What is MOST urgent to add to the study?
What is MOST important to consider in a vaccine campaign that aims to protect against disease X?
What is MOST important to consider in a vaccine campaign that aims to protect against disease X?
Why is the recombinant protein in a subunit vaccination often fused to another carrier protein?
Why is the recombinant protein in a subunit vaccination often fused to another carrier protein?
A novel adjuvant is highly specific for a single Toll-like receptor. In what circumstance should you MOST avoid using it?
A novel adjuvant is highly specific for a single Toll-like receptor. In what circumstance should you MOST avoid using it?
What is the MOST critical reason to perform downstream analytics of B cell isotypes and IgG subclasses after vaccination?
What is the MOST critical reason to perform downstream analytics of B cell isotypes and IgG subclasses after vaccination?
A vaccine manufacturer has developed a pentavalent vaccine and has received approval for its use, but is noticing low seroconversion rates. What is the MOST important consideration?
A vaccine manufacturer has developed a pentavalent vaccine and has received approval for its use, but is noticing low seroconversion rates. What is the MOST important consideration?
Flashcards
Immune Correlates of Protection
Immune Correlates of Protection
Specific immune targets that scientists hypothesize will result in protection from infection.
Natural Passive Immunity
Natural Passive Immunity
Transfer of antibodies from mom to baby (placenta, breast milk).
Natural Active Immunity
Natural Active Immunity
Development of antibodies because of natural infection.
Artificial Passive Immunity
Artificial Passive Immunity
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Artificial Active Immunity
Artificial Active Immunity
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Passive immunity
Passive immunity
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Active immunity
Active immunity
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Who is Edward Jenner?
Who is Edward Jenner?
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Toxic vaccine additives
Toxic vaccine additives
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Vaccines unnecessary?
Vaccines unnecessary?
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Vaccines evil empires?
Vaccines evil empires?
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Vaccine components
Vaccine components
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Vaccines multiple doses
Vaccines multiple doses
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Vaccine factors
Vaccine factors
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Types of vaccines
Types of vaccines
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Live, Attenuated Vaccines
Live, Attenuated Vaccines
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Killed, Inactivated Vaccines
Killed, Inactivated Vaccines
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Toxoids
Toxoids
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Capsular Polysaccharides
Capsular Polysaccharides
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Vectored vaccines
Vectored vaccines
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Nucleic Acid Vaccines
Nucleic Acid Vaccines
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Adjuvants
Adjuvants
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Intrinsic immunity influence
Intrinsic immunity influence
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Environment immunity influence
Environment immunity influence
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Extrinsic immunity influence
Extrinsic immunity influence
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Vaccine clinical testing
Vaccine clinical testing
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Clinical trials: Phase I
Clinical trials: Phase I
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Clinical trials: Phase II
Clinical trials: Phase II
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Clinical trials: Phase III
Clinical trials: Phase III
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Clinical trials: Phase IV
Clinical trials: Phase IV
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Emergency Use Authorization
Emergency Use Authorization
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Infectious diseases
Infectious diseases
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Outbreak
Outbreak
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Endemic
Endemic
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Epidemic
Epidemic
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Pandemic
Pandemic
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Communicable
Communicable
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Vaccine components: Immunogen and packaging
Vaccine components: Immunogen and packaging
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Maternal Immunity Timing impact
Maternal Immunity Timing impact
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Variolation Protection
Variolation Protection
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Thimerosal
Thimerosal
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USPHS action in 1999
USPHS action in 1999
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Toxoid Vaccination Result
Toxoid Vaccination Result
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Capsular Antigen Vaccination
Capsular Antigen Vaccination
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Role of adjuvants
Role of adjuvants
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Study Notes
- Vaccine design and development has evolved over time, considering multiple factors.
- Artificial passive immunity assists in the transfer of ready-made antibodies to immunocompromised individuals.
Natural vs. Artificial Immunity
- Natural immunity is acquired naturally.
- Active natural immunity involves developing antibodies because of natural infection.
- Passive natural immunity involves the transfer of antibodies from the mother to the baby via the placenta or breast milk.
- Artificial immunity supplements one's immunity through vaccination.
- Active artificial immunity induces immunity through antigen exposure via vaccination.
- Passive artificial immunity consists of transferring ready-made antibodies to immunocompromised individuals.
- Active immunity comes from natural infection or inducing an immune response.
- Passive immunity can be transferred between individuals.
Infectious Disease
- Leading cause of death worldwide
- Caused by viruses, bacteria, fungi, and parasites
- Outbreak: pathogen infects numerous people in short time within a small area.
- Endemic: outbreak remains predictable and constant within specific population group.
- Communicable: contagious
- Epidemic: pathogen infects large populations in a region
- Pandemic: pathogen infecting multiple populations over multiple countries.
Vaccine Design & Development
- Vaccine development requires defining specific immune targets, such as effector lymphocytes or soluble proteins.
- Basic safety criteria must be met for vaccines.
- Vaccine effectiveness is determined by monitoring volunteers and collecting samples over time.
- Pathogen-specific factors, like incubation period and mutation rate, are considered.
- Other factors include administration method, storage stability, and cost-effectiveness.
- Clinical testing involves in vitro studies, animal models, and human subjects; only about 10% of subjects make it to distribution.
- The US has four clinical trial phases, each requiring FDA review. These targets are called immune correlates of protection, a goal to protect.
Clinical Trials
- Phase I assesses human safety with a small, closely monitored group.
- Phase II evaluates the vaccine's efficacy or its ability to trigger the desired response.
- Phase III assesses vaccine effectiveness against a benchmark linked to the pathogen.
- This can have a control group
- Emergency Use Authorization (EUA) is applicable with positive Phase II and III results.
- Phase IV involves post-marketing surveillance for safety and effectiveness. Any unexpected symptoms are entered into the Vaccine Adverse Event Reporting System , VAERS, which is run by the FDA and CDC.
- Emergency Use Authorization (EUA) may be granted during health emergencies if the serious/life-threatening disease risk outweighs the vaccine's risks and available treatment lacks.
- It requires at least 2 months of test subject follow up
- Full approval requires 6 months of monitoring
- Marketing and distribution can start with the trial participants.
- Safety and efficacy are continually monitored, specifically through VAERS.
Concepts of Immunization
- Variolation is a method where people are infected with a weaker version of a disease.
- This can protect people from more severe forms of the disease.
- Variolation for small pox protected individuals
- It had a mortality rate of 1 in 100 compared to 1 in 4 with active infection.
- Edward Jenner is credited with developing and sharing immunization practices, and many others were involved, including Onesimus and Dr. John Fewster.
- Dr. John Fewster was using variolation to inoculate farmers for cowpox.
- 1796 - Jenner collected cowpox pustule material and inoculated James Phipps
Anti-Vaxxers
- Common arguments involve vaccine formulations not being safe, human disease being mostly prevented by hygiene, and vaccine companies being out to make money.
- Despite these arguments, vaccines are supported by evidence and regulated by CDC guidelines.
- The main reasons why people are against vaccines are additives, belief that health measures alone are enough and negative perceptions of drug companies.
- Aluminum & Formaldehyde are falsely accused of being toxic components of vaccines.
- Vaccine hesitancy rates are much higher than the refusal rates.
- Of parents who delay and refuse vaccines:
- 70% believe that vaccines are needed to protect their health.
- 63% fear their children will have side effects.
- 57% had concerns about autism.
- 78% believed their children get too many shots
- 77% say medical professionals have their best interests at heart.
Vaccine Components
- The components include:
- An antigenic molecule that serves as the immunogen.
- Packaging is required to protect and deliver the immunogen to the system.
- Conjugates or Adjuvants to increase immunogenicity
- Stabilizers to maintain antigenic structure.
- There also may be carry-over substances from the manufacturing process.
Multiple Dose Vaccinations
- Required because vaccine formulation provides limited antigen amounts to mount an immune response.
- Needed based on if the antigen is live or not.
- Polio vaccine Immunizations ensure adequate immunity to the three poliovirus strains.
- Live-attenuated vaccines has a long-lasting, even lifetime protection.
- Non-live vaccines require three or more doses to achieve maximum safety, and protection fades overtime.
- Examples of multiple vaccinations include; DTaP, flu, & Covid-19.
Vaccine Delivery Timing
- Earlier deliveries can provide reduced risk of contact, where as.
- Later vaccine deliveries can affect maternal antibodies. Maternal Ig can bind to vaccine Ags and block adequate immune responses.
Vaccine Formulations/Types
- Whole Pathogen Vaccines - Live/killed microbes
- Subunit Vaccines
- Particle-Based
- Vectored
- Nucleic Acid
Whole Pathogen Vaccines
- Live/Attenuated vaccines involve an infectious agent that is modified to replicate weakly in the host.
- This provides a strong memory response due to prolonged antigen presentation.
- They have the potential to cause disease.
- Killed/Inactivated Vaccines
- Uses the complete killed pathogen by heat or chemical treatment.
- This is incapable of replication but often requires boosters.
Live vs Killed Vaccines
- Characteristics of Live Attenuated vaccines:* - Strong immune response (presentation on HLA I/ CTL action) & lifelong memory. - Few doses (due to transient growth). - Can mutate to virulence and cause complications, leading to inability to immunize some patients
- Characteristics of Inactivated or Killed vaccines:* - Stable storage properties, safe for attenuated patients & safer than pathogens. - Weaker immune response requiring multiple doses and adjuvants. - Potentially dangerous if pathogen is not killed
Subunit/Conjugate Vaccines
- Subunit/conjugate vaccines contain purified Ags that are weaker immunogens if the adjuvant is not present.
- Toxoids
- Inactivate exotoxins and leads to neutralizing lg.
- Includes tetanus and diphtheria vaccines
- Capsular Polysaccharides
- Are used with disease caused by bacteria species-specific
- Creates capsule antigens resluting in opsonizing Ig
- Eg. Streptococcus Pneumoniae
- Recombinant Proteins
- Pathogens with unique expressed protein uses Ags for cell virulence
- Vaccination with recombinant protein creates neutralizing/opsonizing lg
- Virus such as Hepatitis B.
Vectored Vaccines
- Uses an attenuated pathogen to carry the gene for another pathogen
- J&J and AstraZeneca COVID vaccines used a vector vaccine.
RNA Vaccines
- mRNA Vaccines deliver sequences of host proteins to turn into pathogen-specific antigens.
- The mRNA delivers the antigen by creating a lipid barrier for intramuscular injection
- This Induces humoral and cell-mediated responses
- Pfizer & Moderna
Adjuvants
- Adjuvants enhance the immunogenicity of Ags.
- Aluminium salts can serve as a mineral immunogenic
- Cytokines may also serve as adjuvants
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