Chapter 10 & 11

1. Chapter 10 & 11 Large Scale Vaccine Trials In Resource- Poor Settings Data Collection & Management Group Members: RUBINI DEVI SB09005 KALAISELVI SB09031 SUMITHALAKSMY SB09063 CALVIN LEE SB09018

2. Active Immunization • Active immunization is against a variety of microorganisms or their components, with the ultimate goal of protecting the host against subsequent challenge by the naturally occurring infectious agent.  • The body is exposed to a relatively harmless form of an antigen • The immune system is stimulated, and remembers this antigen if subsequent exposures occur • The immunizations do not cause a full-blown infection.

3. Active Immunizing Agent • Immunizing agent is any substance or organism that provokes an immune response (produces immunity) when introduced into the body. • The active agent of a vaccine may be intact but inactivated (non-infective) or attenuated (with reduced infectivity) forms of the causative pathogens, or purified components of the pathogen that have been found to be highly immunogenic (e.g., the outer coat proteins of a virus).

4. Examples of Active Immunizing Agents BCG vaccine (tuberculosis) Diphtheria, tetanus, and pertussistoxoids Cholera vaccine Haemophilus influenza type b conjugate vaccine Hepatitis A and B virus vaccines Measles, mumps, and rubella virus vaccine, live - several forms Poliovirus vaccine, several forms

5. SMALLPOX VACCINE • Smallpox is a disease that is fatal in 30% of unvaccinated people, caused by the variola virus, an orthopox virus. • However, the smallpox vaccine is not made from the variola virus. The smallpox vaccine contains the live vaccinia virus, another member of the orthopox virus family. • The smallpox vaccine does not cause smallpox, but it can cause a disease called vaccinia. • Smallpox can be prevented with vaccination. • Vaccination up to 3 days after exposure will prevent smallpox or significantly reduce the symptoms and likelihood of death. • Vaccination 4 to 7 days after exposure may still be helpful in reducing the severity of the symptoms.

6. The smallpox vaccine was the first successful vaccine to be developed. • The process of vaccination was discovered by Edward Jenner in 1796. • By 1977, smallpox, long considered to be the most deadly and persistent human pathogenic disease, was eradicated by theWorld Health Organization. • This was accomplished through a massive, worldwide outbreak search and vaccination program • What was the vaccine used?

7. Vaccine Name: Dryvax. The vaccine licensed by the FDA was taken from a weak strain of vaccinia virus called the New York City Board of Health strain. • It was produced by Wyeth Laboratories and licensed under the name Dryvax. • Vaccination site: • - The vaccine is given with a two-pronged needle that is used to prick the skin of the upper arm several times causing a few drops of blood. • - In 3-4 days a red, itchy bump forms. In the first week the bump develops into a blister, then fills with pus, and drains. • - In the second week, the blister dries up and begins to scab over. In the third week, the scab falls off, leaving a scar. • - For a few days after the vaccination, a person can get fever, chills, and swollen lymph nodes.

8. MALARIAVACCINES Malaria continues to be a major health problem in areas of the world where the disease is endemic and in particular in sub-Saharan Africa. It is estimated that 300-500 million people become infected annually and the disease has a very high rate of morbidity and mortality with 1 to 3 million deaths annually attributed to malaria, particularly among infants and children under 5 years of age.

9. Malaria vaccine development strategies are based on the complex life cycle of the parasite in human which includes the • pre-erythrocytic stage, • asexual stage and • gametocyte stage.

10. Pre-erythrocyticstage • initiates the infection • does not cause disease • Pre-erythrocytic vaccines • act to prevent or delay a malaria attack by attacking the sporozoite and liver stages before the parasite reaches the bloodstream.

11. Asexual stage. • causes disease • Asexual Stage Vaccines • formulated using Recombinant-DNA technology • indicate that the complex biology of the plasmodium parasite, its wide antigenic diversity and its immune avoidance strategies make vaccine development against malaria disease demanding

12. Gametocyte stage • infects mosquitoes that transmit the parasite • Gametocyte stage vaccines • known as transmission-blocking vaccine • designed to generate an immune response in human hosts, as a result of which the parasite’s growth into mosquito vector and the eventual transmission of the parasites will be blocked

13. CLINICAL TRIAL An initial safety study in children aged 6-11 years was followed by a second study in children aged 1-5 years. In each, a double-blind, randomized, controlled, staggered dose-escalation design was used to evaluate three different doses of RTS,S/AS02 intramuscular injections delivered as fractional or standard volumes of the adjuvant vaccine on a 0, 1 and 3 month schedule. All three dose levels of RTS,S/AS02 were found to be safe and well tolerated. There were no serious adverse events related to vaccination. All doses were highly immunogenic for anti-CS and anti-HBs antibodies.

14. INFLUENZA VACCINES Also known as flu shot, is an annual vaccine to protect against the highly variable influenza virus. Influenza vaccination is the most effective method for preventing influenza virus infection and its potentially severe complications.

15. Influenza Virus • 10% to 20% of the population is infected with influenza virus each year • Average of more than 200,000 excess hospitalizations each year • Persons 65 and older, 2 years and younger at highest risk • Average of 36,000 die each year • Persons 65 and older at highest risk of death • Highly infectious viral illness • Epidemics reported since 16th century • Virus first isolated in 1933

16. CLINICAL TRIAL Multiple clinical trials of both live and inactivated influenza vaccines against seasonal influenza have been performed and their results pooled and analyzed in several recent meta-analyses. The meta-analyses examined the efficacy and effectiveness of inactivated vaccines against seasonal influenza in adults,children, and the elderly. The influenza vaccine will be able to be used when it is approved by the U.S FDA after the vaccine trial shows positive results and does not cause harm to the group of study.

17. Chapter 11:DATA COLLECTION AND MANAGEMENT

18. Definition • representation of facts or concepts or instructions in a formalized manner, suitable for communication, interpretation or processing by manual or electronic means of data is an item, idea, concept or raw fact.

19. Quantitative and Qualitative researches • In the social sciences, quantitative research refers to the systematic empirical investigation of social phenomena via statistical, mathematical or computational techniques. • The process of measurement is between empirical observation and mathematical expression of quantitative relationships.

20. Qualitative methods produce information only on the particular cases studied, and any more general conclusions are only hypotheses. Quantitative methods can be used to verify, which of such hypotheses are true.

21. Quantitative And Qualitative Data Collections • Quantitative data are anything that can be expressed as a number, or quantified • Qualitative data cannot be expressed as a number. Data that represent nominal scales such as gender, socieo economic status, religious preference are usually considered to be qualitative data

22. Data Presentations • is important in ensuring the quality of statistics and statistical reports • The way data are displayed is important • All presentations should be simple and readable with important facts highlighted.

23. Tables • A table is the simplest means of summarizing a set of observations, and can be used for all types of data • It is an organized arrangement of data, usually appearing in columns (reading down) and rows (reading across).

24. Graphs • A graph should be used as a pictorial representation of numerical data and in most cases proves the best medium for presenting data for quick review of relationships between various factors. • They should be designed so that they convey the general patterns in a set of data at a single glance.

25. Error in data calculation • Experimentally-determined quantities are inaccurate due to measurement error; absolutely 'correct‘ values of physical quantities cannot be found. • The significance of conclusions drawn from data must take measurement error into consideration.

26. There are two broad classes of measurement error: systematic and random • A systematic error is one which affects all measurements of the same variable in the same way. • Random or accidental errors are due to unknown causes present in almost all data