Immunization remains the most cost-effective method of prevention of infectious diseases over the past few decades. This has led to an intensive effort to deploy the strategy of immunization in the control and eradication of infectious diseases. Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks. Consequently, the importance of clinical trials to test the safety, immunogenicity, efficacy, tolerability, appropriate dosing schedule and effectiveness for vaccines cannot be over emphasized as more vaccines are being developed against various pathogens.
Unlike many drug trials to treat diseases, phase III vaccine trials often involve a large number of healthy volunteers in community settings over a period of time. Even though vaccine programs are generally supported by most people, there are often significant misconceptions and sometimes resistance to vaccine in some population groups. Since healthy populations are involved, there is also greater sensitivity to experience of adverse events, even those that are unrelated to vaccines. Community based field trials therefore require special attention and challenges with regard to the provision of information, taking community concerns seriously, and ensuring participation and adherence in clinical trial protocols.
This webinar will provide an overview and discussion of the ethical issues raised by large vaccine field trials carried out and planned in India and abroad. The presentations will address issues of community engagement in the planning of protocols and the preparation of sites, the clinical intervention part, ethical issues related to collection of tissue and data.