title: Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site.
abstract: An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving. In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.
authors: Clinical Development, Malaria Vaccine Development Program, International Centre for Genetic Engineering and Biotechnology Campus, New Delhi, India.
authors: Shantanu
authors: S
authors: Mehta
authors: Clinical Development, Malaria Vaccine Development Program, International Centre for Genetic Engineering and Biotechnology Campus, New Delhi, India.
authors: Vishal
authors: V
authors: Goyal
authors: Clinical Development, Malaria Vaccine Development Program, International Centre for Genetic Engineering and Biotechnology Campus, New Delhi, India.
authors: Kavita
authors: K
authors: Singh
keywords: Clinical trial site; Phase I unit; infrastructure; manpower; subjects; vaccine