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Specifically, the Complex Structure of Infectious Diseases will be responsible for the experimentation, “recruitment” and follow-up of 300 volunteer patients from all over the region.
MODENA The definitive phase 3 trial of the vaccine developed at the University of Oxford and produced by AstraZeneca begins in Italy in December. It begins at the University Hospital of Modena, one of the seven Italian centers chosen to test the vaccine developed by the English University in collaboration with the biopharmaceutical company.
Specifically, the Complex Structure of Infectious Diseases will be in charge of the experimentation, “recruitment” and follow-up of 300 volunteer patients from all over the region.
The announcement, with the presentation of the program, was made today at a press video conference in Modena. “Emilia-Romagna, through one of our excellencies, which is the University Hospital of Modena, plays its role in an experiment that we all waited with great concern: we can only be proud – underlines Raffaele Donini, regional health policy councilor. Once again, the value of public health in our region and the professional quality of those who work there are recognized, putting their skills and energy at the service of the public every day. I want to thank – Donini concludes – all those who will participate in this process, from clinicians to volunteers, in the hope that it will end quickly and positively.
“This is one more demonstration of how the serious and constant commitment of healthcare professionals is rewarded, and how the strong integration between healthcare and the University is always and in any case an inestimable value for a high-level company like ours,” he says. the general director of the University Hospital of Modena, Claudio Vagnini-.
Our complex structure of Infectious Diseases was not selected by chance, but after a series of publications carried out in the previous months from which a very high level of scientific quality emerged. The agency in charge of contracting (Contract Research Organization, Cro) has made several visits in recent months, pointing out that all the conditions are in place to carry out such an important study ”.
In November, 300 volunteers, aged 18 and over, will be enrolled and will undergo a double-blind trial: 200 will receive the vaccine and the other 100 the placebo. A toll-free number will be available soon to obtain information and collect requests. The first 300 who request it and who meet the criteria will be chosen. For the criteria of recruitment of volunteers, Cristina Mussini, director of the complex structure of Infectious Diseases Aou in Modena and professor at UniMoRe explains in videoconference, “300 people, not patients, healthy people of any age (as long as they are adults) and with any pathology, as long as it is in a stable stage. ”For example,“ a compensated diabetic ”or“ an HIV patient with ongoing retroviral therapy ”could be accepted. Those affected by Covid can also participate, but not in the phase acute. Immunosuppressed patients, pregnant women will not be admitted. The aim of the Aou of Modena is to avoid queues and meetings on site: to request, a toll-free number will be available today, while reservations will be managed through an electronic agenda. The place chosen to carry out the administrations is the Aou clinic, where an ad hoc path will be created for those who will undergo experimentation. There is no working group. or dedicated for this test operation: “We have no additional resources at our disposal – explains Mussini – the staff will rotate”. The 2-to-1 double-blind trial means that out of 300 participants, 200 will receive the vaccine dose and the other 100 a placebo. No one, not even medical personnel, will know who is being given what. Only when the blind is opened will even the hundred who had received the placebo be given the vaccine.
