Global Clinical Portfolio of TB Vaccine Candidates
After decades of complacency in TB vaccine R&D, the late 1990s saw global experts and donors move rapidly to advance the first generation of new TB vaccines into human testing. Today, we focus on developing a diverse and robust portfolio of next generation vaccine candidates. Aeras and others in the TB vaccine field have established global criteria to select, asses and advance promising and novel vaccine candidates in the pipeline.
Around the world, more than a dozen different TB vaccines are in various stages of clinical trials. Aeras is a key partner in several of these development programs, helping advance TB vaccines for the people who need them most.
Vaccine candidates must go through a series of clinical trials in order to be proved efficacious and safe for licensure. Each clinical trial phase has been clearly defined by our project management team:
First-in-Human Clinical Trials:
First-in-human studies are small studies in healthy adults - usually 20-80 subjects - to evaluate the safety and immunogenicity of a vaccine candidate.
Phase I Clinical Trials:
Phase I clinical trials are small safety studies in different target populations. These may include a preliminary assessment of dose-range and/or age de-escalation.
Phase IIa Clinical Trials:
Phase IIa clinical trials are larger studies - usually 100-300 subjects - that explore dose-range in target populations with the goal of identifying the optimum dose; the dosing schedule; and/or the route of administration based on safety, immunogenicity and/or biological endpoints. These are focused studies designed to provide evidence of biological activity in the target population.
Phase IIb Clinical Trials:
Phase IIb clinical trials are larger, well-controlled studies that evaluate safety and proof-of-concept/efficacy. These trials usually include more than 1,000 subjects and are designed to demonstrate evidence of disease prevention or treatment in the target population.
Phase III Clinical Trials:
Phase III clinical trials are pivotal registration studies to support licensure. They are designed to demonstrate statistically significant evidence of disease prevention or treatment and long-term safety in target populations as required by national regulatory authorities. These studies are conducted with the final manufactured product.