The Center for Vaccine Development (CVD) has earned an international reputation as an academic vaccine development enterprise for creating and testing vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal Salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, malaria, and other infectious diseases, including influenza.
In addition to its research and outpatient facilities in Baltimore, Maryland, the CVD has fixed facilities to conduct clinical studies in Mali, West Africa, Malawi, Southern Africa and Santiago, Chile and undertakes time-limited field studies in many other countries in Africa, Asia and Latin America. The Center’s international staff includes molecular biologists, microbiologists, immunologists, internists, pediatricians, epidemiologists, malariologists, biostatisticians and informaticians. Myron M. Levine, M.D., D.T.P.H. has been Director of the CVD since its inception in 1974.
The CVD is engaged in the full range of vaccinology from basic laboratory science research through vaccine development, early clinical evaluation, large-scale pre-licensure field studies and post-licensure assessments. Mission priorities include:
- Quantifying the relative disease burden of various pathogens and the range of serotypes or antigenic types through epidemiologic and seroepidemiologic studies.
- Identifying virulence properties through studies of molecular pathogenesis to guide the construction of vaccine candidates.
- Construction of candidate vaccines.
- Assessing the suitability of putative candidate vaccines in pre-clinical studies, including relevant animal models.
- Preparation of Investigational New Drug Applications (INDs) (or their equivalent) for submission to the FDA (or other National Regulatory Agencies) to pave the way for undertaking early (Phase 1 and 2) clinical trials.
- Evaluating the suitability of putative candidate vaccines in early (Phase 1 and 2) clinical studies including clinical acceptability, immunogenicity and (with live vaccines) shedding pattern and transmissibility to contacts.
- Measuring human immune responses to vaccines including serum and mucosal antibodies, cell-mediated immune responses, B and T cell memory responses and immune cell homing patterns.
- Preliminarily assessing the efficacy of certain vaccines (e.g., to prevent Shigella, enterotoxigenic E. coli diarrhea and malaria infection or illness) in small controlled challenge studies.
- Evaluating the efficacy of candidate vaccines in pivotal large-scale, randomized controlled field trials.
- Assessing the safety and impact (on diminishing disease burden) after licensure and large-scale (usually national) programmatic implementation of a vaccine in large populations.
- Advising governments and international agencies on vaccine policy.
- Training the next generation of both laboratory and clinical vaccinologists through structured training programs.