This may differ from therapeutic vaccines or drugs, where the pot

This may differ from therapeutic vaccines or drugs, where the potential improvement of an existing clinical condition may increase a patient’s tolerance or acceptance of certain AEs. The success of clinical studies is based on precise and relevant immunological and clinical endpoints (these are essential if the immune correlates of protection CAL-101 cell line are not known); accurate estimates of sample size based on disease incidence; appropriate numbers of subjects

(to allow for the estimated drop-out rate); and rigorous data management. Safety is an endpoint evaluated throughout all studies. In order to most accurately determine both efficacy and the incidence of AEs, Phase III clinical trials usually enrol a large number of subjects. In these studies Independent Data Monitoring Committees (IDMCs) may be put in place to guarantee continuous surveillance of data produced, and to flag any possible safety concern arising during the study. An example of the importance of this and post-licensure safety evaluations is described in the rotavirus vaccine case study (case study

3). As stated earlier, safety is integral to all aspects of vaccine manufacture and, as such, is continually assessed throughout the entire vaccine development (Figure 5.2). As with all areas of medical research, the development of new vaccines builds on the experience gained in the development of earlier products. Safety is the main endpoint Maraviroc of Phase I clinical trials, and continues to be an important endpoint for all further stages of the clinical development process and post-licensure assessments. Vaccines licensed within the last few years have well-established safety profiles due to the extensive studies and rigorous safety checks to which new vaccines must now be subjected. This is described in the human papillomavirus (HPV) case study below. Case study 1.  Licensed, AS04-adjuvanted HPV-16 and HPV-18 vaccine New generation vaccines containing novel

adjuvants seek to improve on existing vaccines and/or increase the number of diseases that can be targeted by vaccination, as described in Chapter 4 – Vaccine adjuvants. Adjuvants are used to enhance and modulate the immune response to the vaccine antigen. As a result of increasing scrutiny of vaccine safety, especially for new vaccines formulated with novel adjuvants to increase Tyrosine-protein kinase BLK the magnitude of the immune response, the clinical development plan for the AS04-adjuvanted HPV-16 and -18 vaccine included enhanced safety assessments. Investigators and vaccinees were solicited to actively report events requiring medical attention, eg new onset of chronic disorders (NOCDs) and autoimmune (AI) diseases. In addition, the inclusion and exclusion criteria and study design were standardised and harmonised across the HPV clinical plan (to allow for pooling of safety data from the entire database). This effectively increased the sample size of vaccine recipients in order to maximise the chance of detecting a rare adverse event.

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