SlideShare ist ein Scribd-Unternehmen logo
1 von 38
Downloaden Sie, um offline zu lesen
‘ Presented by’-
Piyush A. Bafna
2013H146077H
M. Pharm.(Pharmaceutics)-1st year
28th October 2013
• A ‘Vaccine’ is biological preparation that improves immunity to
particular disease.
• A Vaccine may be prophylactic or therapeutic.
• A Vaccines can be made of Live, Killed or attenuated micro
organisms.
• The term vaccine was firstly used by Edward Jenner in 1796.
• Edward Jenner is thus well known as ‘Father of Immunology’.
Vaccine Clinical trial
Year Discovery
1796 Edward Jenner introduced Small pox vaccine
1880 Louis Pasteur developed attenuated cholera vaccine
1882 Robert Koch isolated tubercle bacilli
1882 Louis pasteur successfully prevented rabies by post
exposure vaccination
1908 Karl Landsteiner and Erwin Popper discovered poliovirus
1924 BCG is introduced as live tuberculosis vaccine
Vaccine Clinical trial
Year Discovery
1961 Albert Sabin developed oral attenuated polio vaccine
1960-
1969
Live attenuated vaccines for Measles , Mumps and Rubella were
developed
2006 First HPV (Human papilloma virus) vaccine is licensed
2012 Polio was eliminated from India
Vaccine Clinical trial
1. Phase I trial- are usually small scale.
2. Phase II trial- are to assess the safety, early efficacy of
selected dose of vaccine.
3. Phase III trial- are usually large in scale and are to
confirm the Efficacy of vaccine in target population.
Vaccine Clinical trial
4.Phase IV- are usually conducted for
collecting information regarding long term
safety or efficacy of vaccine to full fill with
regulatory requirement.
Vaccine Clinical trial
1.Safety studies – Acc.to FDA guidelines, the
studies should be randomized and controlled.
Follow up safety should be actively monitored and
planned. Follow up should be continued at least
30 days for live or killed vaccines.
2.Immunogenicity- The main objective of
comparative immunogenicity study is to rule out
the difference between response to study vaccine
and a control. The differences between Geometric
Mean Titers and/or Sero conversion rates are
studied.
Vaccine Clinical trial
3.Efficacy-Endpoint used to evaluate efficacy
could range from disease incidence to well
established marker with activity.
4.Statistical Considerations- Stratified –
Randomization may be recommended .
For sample size, the FDA requires that sample
size calculation for each study endpoint should be
performed and …
Vaccine Clinical trial
And accordingly the sample size should be
selected.
Vaccine Clinical trial
What is TBE-: It is the disease condition
which is caused by the TBE viruses which
are positive-stranded RNA viruses.
Infectious TBE Viruses enters cells by
receptor mediated endocytosis.
TBE Virus is the Flavi virus infection, that
has been known from more than 50 yrs.
Vaccine Clinical trial
TBE has recently joined the diseases under
surveillance in the European Union; on 5
September 2012, it was included in the list
of notifiable diseases in the European
Union.
Vaccine Clinical trial
TBEV is transmitted by 11 tick species, but
only 2 species are important vectors: Ixodes
ricinus for TBEV-Eu and Ixodes persulcatus
for TBEV-Sib.
Ticks act as both the vector and reservoir for
TBEV.
Vaccine Clinical trial
Sponsor of trial- Novartis vaccines
Estimated Enrollment – 300
Location countries- Germany
Status of study- Completed
Vaccine Clinical trial
- Prepare protocol(s) for human studies.
-Apply for investigational New drug (IND) approval.
-Submit Product Licensure Application MCC
approval .
-Advisory Committees review and make
recommendations.
Vaccine Clinical trial
- Post Marketing Surveillance for safety and
effectiveness (Phase IV).
- Long term process and Usually takes 10- 15
years.
Vaccine Clinical trial
Official title of study-
A Phase IV, Randomized, Controlled, Single-Blind,
Multi-Center Study in Children to Evaluate the
Safety, Tolerability and Immunogenicity of
Two TBE Vaccines Administered According to Two
Different Schedules.
Purpose/Objective of study- The purpose of
this study is to evaluate the safety, immunogenicity
and tolerability of TBE vaccines administered to
children.
Vaccine Clinical trial
Primary Outcome Measures:
Immunogenicity of two pediatric TBE vaccines as
measured by neutralization test and ELISA on days
28, 42, 300, and 321.
Secondary Outcome Measures:
Tolerability of two paediatric TBE vaccines with
respect to local and systemic reactions including fever.
Vaccine Clinical trial
Study type- Interventional
Study phase- Phase IV
Study Design-
Vaccine Clinical trial
Sr.no. Design
1. Allocation- Randomized
2. End point classification- Safety/Efficacy
3. Intervention Model: Parallel Assignment
Sr. no. Design
4. Type- Single blinded
5. 1° purpose- Prevention
Vaccine Clinical trial
The administration scheme for both
vaccines is three doses given intra
muscularly, the first two given with a gap of
three week to 3 month apart and the third
one given nine to twelve months after the
second. Thereafter, a booster dose every
fifth year is recommended.
Vaccine Clinical trial
Sr. No. Vaccination stage Age
1. Primary immunization ≥ 1 year
2. 1st booster ≥ 1 year
3. 2nd booster ≤ 49 years *
Vaccine Clinical trial
All subjects who already had pre immunization
TBE titers showed at least a fourfold increase
post immunization. The latter subjects had
naturally acquired immunity against TBE and
therefore can be regarded as protected against
TBE disease.
Substantial level of neutralizing TBE antibodies
were already be detected.
Vaccine Clinical trial
Vaccine Clinical trial
1.Healthy male and female children, age
group in between 1 to 10 years.
2. Willingness to sign written informed
consent form.
3. Subject agrees to enroll into protocol-
driven long- term follow up for 2 years after
randomization.
Vaccine Clinical trial
1. Age more than 18 years.
2. Pregnancy or lactation.
3. History of autoimmune disease.
4. Administration of other vaccine 4 weeks before or
after day zero.
5. Administration of immuno globulins 6
Weeks prior to any vaccination.
6. Any contraindication specified by manufacturer.
Vaccine Clinical trial
% reduction in attack rate of disease-:
VE (%) = (ARU-ARV) X 100
(ARU)
Where; ARU-unvaccinated individual
ARV- vaccinated individual
Vaccine Clinical trial
Vaccine efficacy- Is given as Reduction in
the incidence of a disease.
VE =1-θ
where;
θ =Relative risk of infection
Vaccine Clinical trial
Marketed formulations-:
1. TBE Moscow Vaccine ® (Russia)
2. FSME-Immun ® (Baxter,Austria)
3. Encepur ® (Novartis Vaccine, Germany)
Vaccine Clinical trial
Vaccine Clinical trial
Vaccines Adjuvant Shelf life Age limit
FSME-IMMUN 0.5ML
Adults
Al(OH)3
24 months MT 16 years
FSME-IMMUN 0.25ML
Junior.
Al(OH)3
24 months 1-16 years
Encepur adults Al(OH)3
24 months MT 14 years
Encepur children Al(OH)3
24 months 1-12 years
-Subjects are analyzed for immunogenicity
achieved after post immunization levels of
TBE antibodies.
-Common range of the side effects already
noted for licensed TBE vaccines was
reported. After the distribution of more than
five million vaccine doses,no potential safety
risk was noted.
Vaccine Clinical trial
Vaccination is the most effective protective
measure against TBE.
Immunization against TBE has also proved cost
effective. It is advisable to increase vaccination
coverage not only among people living in
regions considered at risk of TBE, but also
among travelers who plan to spend some time
in countries where TBE is endemic.
Vaccine Clinical trial
Post-marketing experience supports results
from clinical trials showing that these new TBE
vaccines may safely be used for the
vaccination of children, adolescents, and
adults.
The evaluation of safety and tolerability in
adolescents and adults in the present clinical
program was focused on the monitoring of local
and systemic reactions and the detection of
uncommon or unexpected side effects.
Vaccine Clinical trial
No serious or unexpected adverse events
related to vaccination were reported in these
comprehensive clinical studies involving
more than 7,500 voluntary subjects.
Post-marketing experience has confirmed
the generally high degree of safety and
acceptance of the new TBE vaccines.
Vaccine Clinical trial
1. Low to High grade fever
2. Fatigue and appetite loss
3. Hypersensitivity and local reactions.
Vaccine Clinical trial
1. Liposomal delivery systems
2. Polymeric nanoparticle delivery systems
3. Virosomes
4. Micellar delivery systems
5. Dendrimer based delivery system
Vaccine Clinical trial
Webpages-:
1. Clinicaltrials.gov
2. www.ncbi.nlm.nih.gov/pubmed
3. Par Anderson , Immunological Effects of
TBE Vaccination, 2008.
4. CH Saroja , PK Lakshmi, Shyamala
Bhaskaran, Recent trends in vaccine
delivery systems, vol. I,April 2001.
5. Daniela Amicizia, A. Domnich;
Epidemiology of TBE, Italy, May 2013.Vaccine Clinical trial
Books-:
1. Design and Analysis of clinical trials, 2nd
edition, S. Chung Chow and J. P. Liu.
2. Fundamentals of Clinical trials, 3rd edition, L.
M. Friedman, C. D. Furberg , D. L. DeMets.
Vaccine Clinical trial
Vaccine Clinical trial
Thank u For listening…
Any Question ?

Weitere ähnliche Inhalte

Was ist angesagt?

The ethics of clinical trials
The ethics of clinical trialsThe ethics of clinical trials
The ethics of clinical trialseliweber1980
 
Validity & reliability of screening & diagnostic tests
Validity & reliability of screening & diagnostic testsValidity & reliability of screening & diagnostic tests
Validity & reliability of screening & diagnostic testsTanveerRehman4
 
FDA Guidelines for Drug Development & Approval
FDA Guidelines for Drug Development & ApprovalFDA Guidelines for Drug Development & Approval
FDA Guidelines for Drug Development & Approvalrahimbrave
 
Innovative clinical trial designs
Innovative clinical trial designs Innovative clinical trial designs
Innovative clinical trial designs Emad Shash
 
Cross sectional study-dr.wah
Cross sectional study-dr.wahCross sectional study-dr.wah
Cross sectional study-dr.wahMmedsc Hahm
 
Observational descriptive study: case report, case series & ecological study
Observational descriptive study: case report, case series & ecological studyObservational descriptive study: case report, case series & ecological study
Observational descriptive study: case report, case series & ecological studyPrabesh Ghimire
 
ICSR (individual case safety report)
ICSR (individual case safety report)ICSR (individual case safety report)
ICSR (individual case safety report)ClinosolIndia
 
Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Jobin Kunjumon Vilapurathuu
 
Ethical considerations in Clinical Research Dr Ankita.pptx
Ethical considerations in Clinical Research Dr Ankita.pptxEthical considerations in Clinical Research Dr Ankita.pptx
Ethical considerations in Clinical Research Dr Ankita.pptxClinosolIndia
 

Was ist angesagt? (20)

Case control study
Case control studyCase control study
Case control study
 
Clinical Trials - An Introduction
Clinical Trials - An IntroductionClinical Trials - An Introduction
Clinical Trials - An Introduction
 
Ethics in clinical research
Ethics in clinical researchEthics in clinical research
Ethics in clinical research
 
The ethics of clinical trials
The ethics of clinical trialsThe ethics of clinical trials
The ethics of clinical trials
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
Clinical trial
Clinical trialClinical trial
Clinical trial
 
Validity & reliability of screening & diagnostic tests
Validity & reliability of screening & diagnostic testsValidity & reliability of screening & diagnostic tests
Validity & reliability of screening & diagnostic tests
 
FDA Guidelines for Drug Development & Approval
FDA Guidelines for Drug Development & ApprovalFDA Guidelines for Drug Development & Approval
FDA Guidelines for Drug Development & Approval
 
Innovative clinical trial designs
Innovative clinical trial designs Innovative clinical trial designs
Innovative clinical trial designs
 
Cross sectional study-dr.wah
Cross sectional study-dr.wahCross sectional study-dr.wah
Cross sectional study-dr.wah
 
Observational descriptive study: case report, case series & ecological study
Observational descriptive study: case report, case series & ecological studyObservational descriptive study: case report, case series & ecological study
Observational descriptive study: case report, case series & ecological study
 
ICSR (individual case safety report)
ICSR (individual case safety report)ICSR (individual case safety report)
ICSR (individual case safety report)
 
cohort study
 cohort study cohort study
cohort study
 
ICH GCP
ICH GCPICH GCP
ICH GCP
 
Clinical trials
Clinical  trialsClinical  trials
Clinical trials
 
Clinical Research
Clinical ResearchClinical Research
Clinical Research
 
Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........
 
Ethical considerations in Clinical Research Dr Ankita.pptx
Ethical considerations in Clinical Research Dr Ankita.pptxEthical considerations in Clinical Research Dr Ankita.pptx
Ethical considerations in Clinical Research Dr Ankita.pptx
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
Comparative observational studies
Comparative observational studies Comparative observational studies
Comparative observational studies
 

Andere mochten auch

Clinical Vaccine Development Introduction
Clinical Vaccine Development IntroductionClinical Vaccine Development Introduction
Clinical Vaccine Development Introductionrwmalonemd
 
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...Gaurav Gupta
 
Bio outsource vaccinetesting_usa
Bio outsource vaccinetesting_usaBio outsource vaccinetesting_usa
Bio outsource vaccinetesting_usaMuhammad J. Sadiq
 
vaccine development against malaria parasite
vaccine development against malaria parasitevaccine development against malaria parasite
vaccine development against malaria parasiteswarnendu basak
 
Patient Enrolment Process
Patient Enrolment ProcessPatient Enrolment Process
Patient Enrolment ProcessDeepak Yadav
 
Recommendations to assure the quality, safety and efficacy of tetanus vaccines
Recommendations to assure the quality, safety and efficacy of tetanus vaccines Recommendations to assure the quality, safety and efficacy of tetanus vaccines
Recommendations to assure the quality, safety and efficacy of tetanus vaccines Aref Farokhi Fard
 
Evaluation of vaccines by testing sterility
Evaluation of vaccines by testing sterilityEvaluation of vaccines by testing sterility
Evaluation of vaccines by testing sterilityAyesha Arshad
 
Fragment based screening at inovacia
Fragment based screening at inovaciaFragment based screening at inovacia
Fragment based screening at inovaciaiNovacia AB
 
Exclusion to Inclusion
Exclusion to InclusionExclusion to Inclusion
Exclusion to InclusionLawrie Phipps
 
trial and protocol design
trial and protocol design trial and protocol design
trial and protocol design Rohit K.
 
FujiFilm Ap 3000
FujiFilm Ap 3000FujiFilm Ap 3000
FujiFilm Ap 3000iamdoug
 

Andere mochten auch (20)

Clinical Vaccine Development Introduction
Clinical Vaccine Development IntroductionClinical Vaccine Development Introduction
Clinical Vaccine Development Introduction
 
Clinical Trial Phases
Clinical Trial PhasesClinical Trial Phases
Clinical Trial Phases
 
Clinical trial
Clinical trialClinical trial
Clinical trial
 
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...
Influenza Vaccine - Is it needed in Indian Children - presented at 1st IFICON...
 
Bio outsource vaccinetesting_usa
Bio outsource vaccinetesting_usaBio outsource vaccinetesting_usa
Bio outsource vaccinetesting_usa
 
vaccine development against malaria parasite
vaccine development against malaria parasitevaccine development against malaria parasite
vaccine development against malaria parasite
 
Efficacy testing of the rVSV-ZEBOV Ebola vaccine in Guinea, Dr. Gunnstein No...
Efficacy testing of the rVSV-ZEBOV Ebola vaccine in Guinea, Dr. Gunnstein No...Efficacy testing of the rVSV-ZEBOV Ebola vaccine in Guinea, Dr. Gunnstein No...
Efficacy testing of the rVSV-ZEBOV Ebola vaccine in Guinea, Dr. Gunnstein No...
 
Patient Enrolment Process
Patient Enrolment ProcessPatient Enrolment Process
Patient Enrolment Process
 
Recommendations to assure the quality, safety and efficacy of tetanus vaccines
Recommendations to assure the quality, safety and efficacy of tetanus vaccines Recommendations to assure the quality, safety and efficacy of tetanus vaccines
Recommendations to assure the quality, safety and efficacy of tetanus vaccines
 
Evaluation of vaccines by testing sterility
Evaluation of vaccines by testing sterilityEvaluation of vaccines by testing sterility
Evaluation of vaccines by testing sterility
 
Components of a clinical study protocol
Components of a clinical study protocolComponents of a clinical study protocol
Components of a clinical study protocol
 
Fragment based screening at inovacia
Fragment based screening at inovaciaFragment based screening at inovacia
Fragment based screening at inovacia
 
Exclusion to Inclusion
Exclusion to InclusionExclusion to Inclusion
Exclusion to Inclusion
 
Fbdd
FbddFbdd
Fbdd
 
HIV Vaccine Development Strategies
HIV Vaccine Development StrategiesHIV Vaccine Development Strategies
HIV Vaccine Development Strategies
 
Clinical trial
Clinical trialClinical trial
Clinical trial
 
Fragment_Based_Drug_Design_Abbott
Fragment_Based_Drug_Design_AbbottFragment_Based_Drug_Design_Abbott
Fragment_Based_Drug_Design_Abbott
 
trial and protocol design
trial and protocol design trial and protocol design
trial and protocol design
 
angina pectoris
angina pectorisangina pectoris
angina pectoris
 
FujiFilm Ap 3000
FujiFilm Ap 3000FujiFilm Ap 3000
FujiFilm Ap 3000
 

Ähnlich wie Vaccine clinical trial

Vaccines and their clinical phase(1,2,3)
Vaccines and their clinical phase(1,2,3)Vaccines and their clinical phase(1,2,3)
Vaccines and their clinical phase(1,2,3)vivek singh
 
Nisha revrse vaccinology
Nisha revrse vaccinology Nisha revrse vaccinology
Nisha revrse vaccinology Dr Nisha Singh
 
Handbook on adult_immunization_2009_(contents)
Handbook on adult_immunization_2009_(contents)Handbook on adult_immunization_2009_(contents)
Handbook on adult_immunization_2009_(contents)raissa_09
 
Bacterialvaccine (1).ppt
Bacterialvaccine (1).pptBacterialvaccine (1).ppt
Bacterialvaccine (1).pptVandanaVats8
 
Presentation on conventional vaccine (Quality Control and Production aspects)
Presentation on conventional vaccine (Quality Control and Production aspects)Presentation on conventional vaccine (Quality Control and Production aspects)
Presentation on conventional vaccine (Quality Control and Production aspects)Sunny Rathee
 
Immunization schedule
Immunization scheduleImmunization schedule
Immunization scheduleanjalatchi
 
5 Types of COVID-19 Vaccines.pdf
5 Types of COVID-19 Vaccines.pdf5 Types of COVID-19 Vaccines.pdf
5 Types of COVID-19 Vaccines.pdfDoriaFang
 
Vaccine design
Vaccine design Vaccine design
Vaccine design RESHMA R
 
Chicken pox vaccine presentation jalandhar july 2017
Chicken pox vaccine presentation jalandhar july 2017Chicken pox vaccine presentation jalandhar july 2017
Chicken pox vaccine presentation jalandhar july 2017Gaurav Gupta
 
Vaccines –production and application
Vaccines –production and applicationVaccines –production and application
Vaccines –production and application2624
 
Recent advances in Vaccine_Dr. Mansij Biswas
Recent advances in Vaccine_Dr. Mansij BiswasRecent advances in Vaccine_Dr. Mansij Biswas
Recent advances in Vaccine_Dr. Mansij BiswasMansij Biswas
 
new generation vaccine.pptx
new generation vaccine.pptxnew generation vaccine.pptx
new generation vaccine.pptxIqraIqra72
 

Ähnlich wie Vaccine clinical trial (20)

Fish Vaccination
Fish Vaccination Fish Vaccination
Fish Vaccination
 
Human parasite vaccines
Human parasite vaccinesHuman parasite vaccines
Human parasite vaccines
 
Adult vaccination
Adult vaccinationAdult vaccination
Adult vaccination
 
Vaccines and their clinical phase(1,2,3)
Vaccines and their clinical phase(1,2,3)Vaccines and their clinical phase(1,2,3)
Vaccines and their clinical phase(1,2,3)
 
Nisha revrse vaccinology
Nisha revrse vaccinology Nisha revrse vaccinology
Nisha revrse vaccinology
 
Handbook on adult_immunization_2009_(contents)
Handbook on adult_immunization_2009_(contents)Handbook on adult_immunization_2009_(contents)
Handbook on adult_immunization_2009_(contents)
 
Bacterialvaccine (1).ppt
Bacterialvaccine (1).pptBacterialvaccine (1).ppt
Bacterialvaccine (1).ppt
 
Presentation on conventional vaccine (Quality Control and Production aspects)
Presentation on conventional vaccine (Quality Control and Production aspects)Presentation on conventional vaccine (Quality Control and Production aspects)
Presentation on conventional vaccine (Quality Control and Production aspects)
 
Vaccine Development in Global Pandemic (COVID-19)
Vaccine Development in Global Pandemic (COVID-19)Vaccine Development in Global Pandemic (COVID-19)
Vaccine Development in Global Pandemic (COVID-19)
 
Immunization schedule
Immunization scheduleImmunization schedule
Immunization schedule
 
Vaccine trial 30.09.2022.pptx
Vaccine trial 30.09.2022.pptxVaccine trial 30.09.2022.pptx
Vaccine trial 30.09.2022.pptx
 
5 Types of COVID-19 Vaccines.pdf
5 Types of COVID-19 Vaccines.pdf5 Types of COVID-19 Vaccines.pdf
5 Types of COVID-19 Vaccines.pdf
 
Early Onset Neonatal Sepsis questions and controversies
Early Onset Neonatal Sepsis  questions and controversiesEarly Onset Neonatal Sepsis  questions and controversies
Early Onset Neonatal Sepsis questions and controversies
 
Vaccine design
Vaccine design Vaccine design
Vaccine design
 
Chicken pox vaccine presentation jalandhar july 2017
Chicken pox vaccine presentation jalandhar july 2017Chicken pox vaccine presentation jalandhar july 2017
Chicken pox vaccine presentation jalandhar july 2017
 
IMMUNIZATION.pptx
IMMUNIZATION.pptxIMMUNIZATION.pptx
IMMUNIZATION.pptx
 
Immunization.pptx
Immunization.pptxImmunization.pptx
Immunization.pptx
 
Vaccines –production and application
Vaccines –production and applicationVaccines –production and application
Vaccines –production and application
 
Recent advances in Vaccine_Dr. Mansij Biswas
Recent advances in Vaccine_Dr. Mansij BiswasRecent advances in Vaccine_Dr. Mansij Biswas
Recent advances in Vaccine_Dr. Mansij Biswas
 
new generation vaccine.pptx
new generation vaccine.pptxnew generation vaccine.pptx
new generation vaccine.pptx
 

Kürzlich hochgeladen

ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptPradnya Wadekar
 
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...bkling
 
Role of Soap based and synthetic or syndets bar
Role of  Soap based and synthetic or syndets barRole of  Soap based and synthetic or syndets bar
Role of Soap based and synthetic or syndets barmohitRahangdale
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyZurück zum Ursprung
 
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptx
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptxGood Laboratory Practice (GLP) in Pharma-LikeWays.pptx
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptxLikeways
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.pptRamDBawankar1
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.whalesdesign
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...Shubhanshu Gaurav
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Peter Embi
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfHongBiThi1
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationMedicoseAcademics
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentsaileshpanda05
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxNaveenkumar267201
 
Physiotherapy Management of Rheumatoid Arthritis
Physiotherapy Management of Rheumatoid ArthritisPhysiotherapy Management of Rheumatoid Arthritis
Physiotherapy Management of Rheumatoid ArthritisNilofarRasheed1
 
Microbiology lecture presentation-1.pptx
Microbiology lecture presentation-1.pptxMicrobiology lecture presentation-1.pptx
Microbiology lecture presentation-1.pptxkitati1
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptPradnya Wadekar
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxMAsifAhmad
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionkrishnareddy157915
 
The Importance of Mental Health: Why is Mental Health Important?
The Importance of Mental Health: Why is Mental Health Important?The Importance of Mental Health: Why is Mental Health Important?
The Importance of Mental Health: Why is Mental Health Important?Ryan Addison
 

Kürzlich hochgeladen (20)

ayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologypptayurvedic formulations herbal drug technologyppt
ayurvedic formulations herbal drug technologyppt
 
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...
Moving Forward After Uterine Cancer Treatment: Surveillance Strategies, Testi...
 
Role of Soap based and synthetic or syndets bar
Role of  Soap based and synthetic or syndets barRole of  Soap based and synthetic or syndets bar
Role of Soap based and synthetic or syndets bar
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturally
 
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptx
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptxGood Laboratory Practice (GLP) in Pharma-LikeWays.pptx
Good Laboratory Practice (GLP) in Pharma-LikeWays.pptx
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
FDMA FLAP - The first dorsal metacarpal artery (FDMA) flap is used mainly for...
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing student
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
 
Physiotherapy Management of Rheumatoid Arthritis
Physiotherapy Management of Rheumatoid ArthritisPhysiotherapy Management of Rheumatoid Arthritis
Physiotherapy Management of Rheumatoid Arthritis
 
Microbiology lecture presentation-1.pptx
Microbiology lecture presentation-1.pptxMicrobiology lecture presentation-1.pptx
Microbiology lecture presentation-1.pptx
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.ppt
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung function
 
The Importance of Mental Health: Why is Mental Health Important?
The Importance of Mental Health: Why is Mental Health Important?The Importance of Mental Health: Why is Mental Health Important?
The Importance of Mental Health: Why is Mental Health Important?
 

Vaccine clinical trial

  • 1. ‘ Presented by’- Piyush A. Bafna 2013H146077H M. Pharm.(Pharmaceutics)-1st year 28th October 2013
  • 2. • A ‘Vaccine’ is biological preparation that improves immunity to particular disease. • A Vaccine may be prophylactic or therapeutic. • A Vaccines can be made of Live, Killed or attenuated micro organisms. • The term vaccine was firstly used by Edward Jenner in 1796. • Edward Jenner is thus well known as ‘Father of Immunology’. Vaccine Clinical trial
  • 3. Year Discovery 1796 Edward Jenner introduced Small pox vaccine 1880 Louis Pasteur developed attenuated cholera vaccine 1882 Robert Koch isolated tubercle bacilli 1882 Louis pasteur successfully prevented rabies by post exposure vaccination 1908 Karl Landsteiner and Erwin Popper discovered poliovirus 1924 BCG is introduced as live tuberculosis vaccine Vaccine Clinical trial
  • 4. Year Discovery 1961 Albert Sabin developed oral attenuated polio vaccine 1960- 1969 Live attenuated vaccines for Measles , Mumps and Rubella were developed 2006 First HPV (Human papilloma virus) vaccine is licensed 2012 Polio was eliminated from India Vaccine Clinical trial
  • 5. 1. Phase I trial- are usually small scale. 2. Phase II trial- are to assess the safety, early efficacy of selected dose of vaccine. 3. Phase III trial- are usually large in scale and are to confirm the Efficacy of vaccine in target population. Vaccine Clinical trial
  • 6. 4.Phase IV- are usually conducted for collecting information regarding long term safety or efficacy of vaccine to full fill with regulatory requirement. Vaccine Clinical trial
  • 7. 1.Safety studies – Acc.to FDA guidelines, the studies should be randomized and controlled. Follow up safety should be actively monitored and planned. Follow up should be continued at least 30 days for live or killed vaccines. 2.Immunogenicity- The main objective of comparative immunogenicity study is to rule out the difference between response to study vaccine and a control. The differences between Geometric Mean Titers and/or Sero conversion rates are studied. Vaccine Clinical trial
  • 8. 3.Efficacy-Endpoint used to evaluate efficacy could range from disease incidence to well established marker with activity. 4.Statistical Considerations- Stratified – Randomization may be recommended . For sample size, the FDA requires that sample size calculation for each study endpoint should be performed and … Vaccine Clinical trial
  • 9. And accordingly the sample size should be selected. Vaccine Clinical trial
  • 10. What is TBE-: It is the disease condition which is caused by the TBE viruses which are positive-stranded RNA viruses. Infectious TBE Viruses enters cells by receptor mediated endocytosis. TBE Virus is the Flavi virus infection, that has been known from more than 50 yrs. Vaccine Clinical trial
  • 11. TBE has recently joined the diseases under surveillance in the European Union; on 5 September 2012, it was included in the list of notifiable diseases in the European Union. Vaccine Clinical trial
  • 12. TBEV is transmitted by 11 tick species, but only 2 species are important vectors: Ixodes ricinus for TBEV-Eu and Ixodes persulcatus for TBEV-Sib. Ticks act as both the vector and reservoir for TBEV. Vaccine Clinical trial
  • 13. Sponsor of trial- Novartis vaccines Estimated Enrollment – 300 Location countries- Germany Status of study- Completed Vaccine Clinical trial
  • 14. - Prepare protocol(s) for human studies. -Apply for investigational New drug (IND) approval. -Submit Product Licensure Application MCC approval . -Advisory Committees review and make recommendations. Vaccine Clinical trial
  • 15. - Post Marketing Surveillance for safety and effectiveness (Phase IV). - Long term process and Usually takes 10- 15 years. Vaccine Clinical trial
  • 16. Official title of study- A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules. Purpose/Objective of study- The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children. Vaccine Clinical trial
  • 17. Primary Outcome Measures: Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321. Secondary Outcome Measures: Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever. Vaccine Clinical trial
  • 18. Study type- Interventional Study phase- Phase IV Study Design- Vaccine Clinical trial Sr.no. Design 1. Allocation- Randomized 2. End point classification- Safety/Efficacy 3. Intervention Model: Parallel Assignment
  • 19. Sr. no. Design 4. Type- Single blinded 5. 1° purpose- Prevention Vaccine Clinical trial
  • 20. The administration scheme for both vaccines is three doses given intra muscularly, the first two given with a gap of three week to 3 month apart and the third one given nine to twelve months after the second. Thereafter, a booster dose every fifth year is recommended. Vaccine Clinical trial
  • 21. Sr. No. Vaccination stage Age 1. Primary immunization ≥ 1 year 2. 1st booster ≥ 1 year 3. 2nd booster ≤ 49 years * Vaccine Clinical trial
  • 22. All subjects who already had pre immunization TBE titers showed at least a fourfold increase post immunization. The latter subjects had naturally acquired immunity against TBE and therefore can be regarded as protected against TBE disease. Substantial level of neutralizing TBE antibodies were already be detected. Vaccine Clinical trial
  • 24. 1.Healthy male and female children, age group in between 1 to 10 years. 2. Willingness to sign written informed consent form. 3. Subject agrees to enroll into protocol- driven long- term follow up for 2 years after randomization. Vaccine Clinical trial
  • 25. 1. Age more than 18 years. 2. Pregnancy or lactation. 3. History of autoimmune disease. 4. Administration of other vaccine 4 weeks before or after day zero. 5. Administration of immuno globulins 6 Weeks prior to any vaccination. 6. Any contraindication specified by manufacturer. Vaccine Clinical trial
  • 26. % reduction in attack rate of disease-: VE (%) = (ARU-ARV) X 100 (ARU) Where; ARU-unvaccinated individual ARV- vaccinated individual Vaccine Clinical trial
  • 27. Vaccine efficacy- Is given as Reduction in the incidence of a disease. VE =1-θ where; θ =Relative risk of infection Vaccine Clinical trial
  • 28. Marketed formulations-: 1. TBE Moscow Vaccine ® (Russia) 2. FSME-Immun ® (Baxter,Austria) 3. Encepur ® (Novartis Vaccine, Germany) Vaccine Clinical trial
  • 29. Vaccine Clinical trial Vaccines Adjuvant Shelf life Age limit FSME-IMMUN 0.5ML Adults Al(OH)3 24 months MT 16 years FSME-IMMUN 0.25ML Junior. Al(OH)3 24 months 1-16 years Encepur adults Al(OH)3 24 months MT 14 years Encepur children Al(OH)3 24 months 1-12 years
  • 30. -Subjects are analyzed for immunogenicity achieved after post immunization levels of TBE antibodies. -Common range of the side effects already noted for licensed TBE vaccines was reported. After the distribution of more than five million vaccine doses,no potential safety risk was noted. Vaccine Clinical trial
  • 31. Vaccination is the most effective protective measure against TBE. Immunization against TBE has also proved cost effective. It is advisable to increase vaccination coverage not only among people living in regions considered at risk of TBE, but also among travelers who plan to spend some time in countries where TBE is endemic. Vaccine Clinical trial
  • 32. Post-marketing experience supports results from clinical trials showing that these new TBE vaccines may safely be used for the vaccination of children, adolescents, and adults. The evaluation of safety and tolerability in adolescents and adults in the present clinical program was focused on the monitoring of local and systemic reactions and the detection of uncommon or unexpected side effects. Vaccine Clinical trial
  • 33. No serious or unexpected adverse events related to vaccination were reported in these comprehensive clinical studies involving more than 7,500 voluntary subjects. Post-marketing experience has confirmed the generally high degree of safety and acceptance of the new TBE vaccines. Vaccine Clinical trial
  • 34. 1. Low to High grade fever 2. Fatigue and appetite loss 3. Hypersensitivity and local reactions. Vaccine Clinical trial
  • 35. 1. Liposomal delivery systems 2. Polymeric nanoparticle delivery systems 3. Virosomes 4. Micellar delivery systems 5. Dendrimer based delivery system Vaccine Clinical trial
  • 36. Webpages-: 1. Clinicaltrials.gov 2. www.ncbi.nlm.nih.gov/pubmed 3. Par Anderson , Immunological Effects of TBE Vaccination, 2008. 4. CH Saroja , PK Lakshmi, Shyamala Bhaskaran, Recent trends in vaccine delivery systems, vol. I,April 2001. 5. Daniela Amicizia, A. Domnich; Epidemiology of TBE, Italy, May 2013.Vaccine Clinical trial
  • 37. Books-: 1. Design and Analysis of clinical trials, 2nd edition, S. Chung Chow and J. P. Liu. 2. Fundamentals of Clinical trials, 3rd edition, L. M. Friedman, C. D. Furberg , D. L. DeMets. Vaccine Clinical trial
  • 38. Vaccine Clinical trial Thank u For listening… Any Question ?