Vaccine ethics meeting in Philadelphia held by IVI and the Center for Vaccine Ethics and Policy
At the end of May, IVI in collaboration with the Center for Vaccine Ethics and Policy (CVEP) at the University of Pennsylvania in Philadelphia convened a two-day ethics meeting. The aim of the meeting was to explore the background and ethical issues around the possibility of conducting a clinical trial to evaluate the efficacy of an oral cholera vaccine (OCV) when given as a single dose. The OCV, Shanchol™, was developed through IVI and licensed in India as a two-dose vaccine. Subsequent observations by IVI appear to indicate that sufficient protection against cholera may be provided after one dose instead of two doses of the vaccine. This has important implications since a one-dose vaccine regimen would be more desirable for use in crisis situations and resource-limited settings where cholera tends to flourish.
The principal ethical challenge associated with a potential single dose trial is the standard-of-care issue raised by the use of placebo when the vaccine involved is already locally licensed and WHO pre-qualified. Additional topics of discussion included whether there is fair benefit to trial participants and the community; the use of OCV in humanitarian, emergency, and epidemic situations; and informed consent for a clinical trial with standard-of-care issues involved.
About 40 people participated in the two-day meeting, including representatives from CVEP, WHO, and IVI and its research partners India's National Institute of Cholera and Enteric Diseases (NICED) and Shantha Biotechnics. Leading vaccine and bioethics experts from academia, government, and industry such as Dr. Collin O'Neil, assistant professor/faculty fellow at the Center for Bioethics at New York University; Dr. Stanley Plotkin, Emeritus Professor, Wistar Institute and University of Pennsylvania; and Dr. David A. Sack, Professor in the Department of International Health at Johns Hopkins University also participated. David Curry, co-founder and Executive Director of CVEP, and Dr. Arthur Caplan, Professor of Bioethics at the University of Pennsylvania Perelman School of Medicine, were instrumental in organizing the meeting. A white paper will be published as a result of the meeting.