|
Laboratory & animal studies |
Laboratory & animal studies |
Laboratory
& animal studies |
Exploratory stage
|
Antigen identification & concept validation
|
2-4 years
|
• Research-intensive stage
• Desired natural or synthetic antigen detection or production
|
Preclinical Stage
|
Safety & immunogenicity of vaccine candidates, starting dose
determination for further studies
|
1-2 years
|
• Tissue- or cell-culture & animal testing
• Adjuvant selection
• Immunogenicity studies
• Good Laboratory Practices (GLP) safety studies (in vivo validation)
• Potency assay development
• Infection challenge studies with the animals
|
Clinical Stages |
FDA approval during 30 days &
subjecting to human studies |
FDA approval during 30
days & subjecting to human studies |
FDA approval
during 30 days & subjecting to human studies |
Phase I
|
Safety & immunogenicity of vaccine candidates
|
˂ 1 year
|
• Involves a small group of healthy adults (20-100 subjects)
• Usually, non-blinded studies
• May be using challenge model in a small part of participants
• An attenuated or modified copy of pathogen applied for challenging
• Evaluating local & systemic reactions
• Relating dose size to the side effects
|
Phase II
|
Safety & immunogenicity, proposed doses, schedule of immunizations
method of delivery, partial efficacy
|
2 years
|
• Randomized & well-controlled trials
• Hundreds of healthy adults
• May contain at risk groups
• Evaluating clinical & laboratory responses (antibody response)
• Determining most common short-term side effects
|
Phase III
|
Safety & efficacy
|
Many years
|
• Determining efficacy & safety in target population (thousands)
• Determining certain rare side effects
• Randomized & double-blind studies
• Involve the experimental vaccine against placebo
• Evaluating disease & infection prevention
• Evaluating antibody or other pathogen related immunity
|
Regulatory approval & licensure
|
Marketing authorization
|
In progress
|
• Submitting a Biologics License Application to the FDA
• Inspecting facilities &reviewing the manufacturer’s tests for
potency, safety & purity by FDA
• Vaccine approval (granted for an initial 5 years)
|
Phase IV
|
Post marketing safety & efficacy
|
In progress
|
• Conduct after vaccine releasing
• Testing safety, efficacy, & other potentials by manufacturer
• Collecting data from vaccinated individuals
|