Italy is about to kick off phase 3 testing for the Covid-19 vaccine developed byOxford University together with the biopharmaceutical giant Astrazeneca. Among the seven centers chosen in our country, the experimentation will beginModena University Hospital. Here the inoculations should start on December XNUMXst.
300 volunteers will be chosen for the experimentation
Over the course of this month, 300 volunteers, aged 18 and over, will be enrolled to undergo double-blind trials. 200 of them will be given the vaccine, the other 100 the placebo. The first 300 who will apply to apply will be chosen by contacting a toll-free number that will be announced soon. In the meantime, many phone calls from people who want to know more have already been recorded at the switchboard of the polyclinic.
The University Hospital of Modena, "very high level of scientific quality"
The choice of the Modena university hospital was not accidental. With satisfaction, the general manager, Claudius Vagnini, declared: “Our complex infectious disease facility was selected following a series of publications made in the previous months, which revealed the very high level of scientific quality. The agency that takes care of the recruitments has made several visits in recent months, noting that here all the conditions exist to be able to conduct such an important study ".
The requirements of the candidates
To be selected, candidates must meet certain requirements. He explained it Cristina Mussini, director of the Aou Infectious Diseases complex in Modena and UniMoRe teacher. The subjects to be identified must be “non-patients, healthy people of any age (as long as they are of age) and with any pathology, as long as they are in a stable stage”. Those affected by Covid-19 can also participate, but not in the acute phase. Immunosuppressed patients and pregnant women will not be admitted. The administrations will be carried out at the clinic of the health facility. Nobody, not even medical staff, will know who will be given the vaccine or the placebo.
The experimentation of phase 3: a challenge to be met
Also the person responsible for the laboratory part of the Oxford-Astrazeneca vaccine trial, Andrea Cossarizza, full professor of General Pathology and Immunology at UniMoRe, spoke on the matter. In a statement released to Ansa, he defined the experiment "A race against time". A challenge that "in Modena we are perfectly capable of supporting, even if it will be tough, even if we will work 24 hours a day, seven days a week, at Christmas and New Year". In this work, Cossarizza will be joined by the researchers Lara Gibellini e Sarah DeBiasi, by PhD students, postgraduates and postdocs. “We - concluded the professor - are equipped for the collection and storage of volunteers' blood samples, but also for analyzes. The procedures - he concluded - are still all in the 140 pages of the protocol that I received and are still to be studied properly ".
Experimentation: the study of samples
The subjects recruited for the phase 3 trial will be subjected to several blood samples both before the two administrations of the vaccine, or the placebo, and subsequently over the course of two years. The blood of each sample will be split into plasma and cells, the first stored at - 80 degrees and the second in bins with liquid nitrogen at -180 degrees. A complex study will be carried out on each sample: in the plasma the researchers will look for antibodies, in the cells the molecules derived from the coronavirus will be tested, to see how the lymphocytes behave and understand if there is and how long the immune response lasts.
A hope
AstraZeneca's Director of Oncology Research and Development, Joseph Baselga, recently stated that the vaccine's distribution will be at an advanced stage by the end of the first quarter of 2021, and that it will be sold at its production price, which is 2 euros. So we just have to wait and hope in science.
