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User Info	Simply Put: FUCK YOU; entered at 2021-08-21 15:34:34
Mabman Posts: 220 Registered: 2009-11-08 toronto	challenge trials in humans https://www.who.int/biologicals/expert_c.... Human challenge trials are trials in which participants are intentionally challenged (whether or not they have been vaccinated) with an infectious disease organism. This challenge organism may be close to wild-type and pathogenic, adapted and/or attenuated from wild-type with less or no pathogenicity, or genetically modified in some manner. In July 2014, WHO held a consultation on Clinical evaluation of vaccines: regulatory expectations (1). One area that was considered as an important issue for facilitating vaccine development was related to human challenge trials. It was recognized that regulation of these trials need to be well defined by the NRAs and vaccine developers and manufacturers need to be aware of regulatory expectations. The document on human challenge trials should be read in conjunction with the updated Guidelines on clinical evaluation of vaccines: regulatory expectations, adopted by the ECBS in October 2016. 2. Scope The scope of this document is to provide guidance to national regulatory authorities (NRAs), manufacturers, vaccine developers, investigators, independent ethics committees, and potentially biosafety committees and national agencies that regulate genetically modified organisms (GMOs) if separate from the NRA. Only issues relevant specifically to the design and conduct of clinical trials enrolling healthy adult humans capable of truly informed consent and that involve the intentional exposure and potential infection with an infectious disease organism are discussed. All other issues common to the design, conduct and evaluation (assessment) of vaccine clinical trials may be found in the document Clinical evaluation of vaccines: regulatory aspects, which is to be considered by the WHO Expert Committee on Biological Standardization in October 2016. 3. Introduction Infectious human challenge studies involve deliberate exposure of human volunteers to infectious agents. Human challenge studies have been conducted over hundreds of years and have contributed vital scientific knowledge that has led to advances in the development of drugs and vaccines. Nevertheless, such research can appear to be in conflict with the guiding principle in medicine to do no harm. Well documented historical examples of human exposure studies would be considered unethical by current standards. It is essential that challenge studies be conducted within an ethical framework in which truly informed consent is given. When conducted, human challenge studies should be undertaken with abundant forethought, caution, POST ECBS version Page 4 and oversight. The value of the information to be gained should clearly justify the risks to human subjects. Information to be gained should clearly justify the risks to human subjects. Although human challenge trials are not a required element of every vaccine development programme, there are many reasons why a developer may request to conduct with humans a challenge-protection study that might normally be conducted in animals. Animal models are often quite imprecise in reflecting human disease, and many infectious organisms against which a developer might wish to develop a vaccine are species-specific for humans. Human challenge trials may be safely and ethically performed in some cases, if properly designed and conducted. Tremendous insight into the mode of action and the potential for benefit in the relevant species humans may be gained from challenge trials. However, there are also limitations to what challenge trials may be able to ascertain because, like animal model challenge-protection studies, a human challenge trial represents a model system. Because there are often such significant limitations to animal models, the model system of the human challenge trial may significantly advance, streamline and/or accelerate vaccine development (2). It is important to note that not all diseases for which vaccines might be developed are suitable for conducting human challenge trials. In many cases, human challenge with a virulent or even an attenuated organism would not be considered ethical or safe. For example, if an organism causes a disease with a high case fatality rate (or there is a long and uncertain latency period) and there are no existing therapies to prevent or ameliorate disease and preclude death, then it would not be appropriate to consider human challenge trials with such an organism. However, a human challenge trial might be considered when the disease an organism causes has an acute onset, can be readily and objectively detected, and existing efficacious treatments (whether curative or palliative) can be administered at an appropriate juncture in disease development to prevent significant morbidity (and eliminate mortality). 2021-08-21 15:34:34