The idea is to bet on a vaccine 100% Italian, while to tackle the pandemic that does not give respite, we try to follow the path of the production on the national territory of vaccines already approved against the Covid19, involving those plants that place Italy at the forefront of the continent in the pharmaceutical field. There are currently two candidates for immunization with the Made in Italy brand under study.
Takis
A few days ago the first phase of experimentation of the DNA vaccine candidate conceived by Takis and developed in collaboration with Rottapharm, biotech sponsor of the study, which will be conducted in Monza, Rome and Naples. Phase 1 will involve 80 healthy adult volunteers under the age of 65 divided into 4 groups of 20 people each. The four parallel cohorts will receive four different strengths, three with booster and one maximum in single-dose (0.5 mg, 1 mg and 2mg with booster and 4mg in single-dose).
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In three months, the researchers plan to evaluate the safety and immunogenicity of E-wax, arriving “at defining doses and treatment schemes to be carried out in phase 2 of the experimentation”, explains the professor Marina Cazzaniga of the University of Milan Bicocca and director of the Phase I Research Center of the San Gerardo hospital in Monza, a facility in which “the first six sentinel patients of each cohort will be followed and, from the seventh patient onwards, enrollment will be competitive between the various centers involved “.
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The other centers, established by the financing company, are the National Cancer Institute IRCCS Pascale Foundation of Naples and the National Institute of Infectious Diseases Lazzaro Spallanzani of Rome, which will deal with the analysis of antibodies to document the immune response and therefore the potential efficacy of the vaccine. The number of subjects in phase 2 will depend on how many dosages will arrive and therefore “our register of volunteers, active since August and already very large, is still open to new registrations – he explains. Cazzaniga – Phase 3 could start next January “.
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The route of administration of the vaccine will not be a simple intramuscular one, but uses a technique, theelectroporation, already in use in electrochemotherapy for the treatment of skin lesions of tumors: “Some types of tumors are treated by inserting these electrodes in the area surrounding the tumor lesion – explains the oncologist Cazzaniga – but the shock, which here is used to determine death tumor, has a different voltage as well as a different purpose. The method used for vaccination is the same, the electrodes are very thin, four small insulin needles, and the syringe with the vaccine is positioned centrally. After vaccination, a flashing of the duration of 18 milliseconds allows to fragment the DNA, thus accelerating the production process of viral antigens and therefore the recall of antibodies “. The Italian company Igea di Carpi that produces the electroporator is working on a portable model.
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DNA technology allows to overcome the problems of the cold chain for the storage of vials, making storage easier. The other big advantage lies in the adaptability of the vaccine, explains Cazzaniga: “Faced with the possible emerging variants of the virus, the vaccine can be modified quickly, it is in fact much more difficult to modify an RNA platform”. Speed has in fact been the watchword for many months now. However, Cazzaniga does not fail to point out: “Research is a race that is won over distance, therefore pursuing the goal requires great tenacity: it is necessary to give science its time, because we must produce solid and safe results”.
GRAd-COV2
In the most advanced phase of experimentation, the other all-Italian vaccine, GRAd-CoV2, is being prepared for phase 2, created, produced and patented by the Italian biotechnology company ReiThera, based in Castel Romano, and developed in collaboration with the Institute. Spallanzani of Rome and the Clinical Research Center of the Integrated University Hospital of Verona. Phase 1 was conducted on a total of 90 healthy volunteers, divided into six parallel cohorts, three groups with subjects aged between 18 and 55 years and another three with the age group 65-85 years, who were administered three different dosages. The ok for phase 2, which will involve about 900 volunteers, has already arrived from the Italian Medicines Agency and the Istituto Superiore di Sanità (ISS).
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Phase 1 results show a robust immune response in 90% of subjects and no serious adverse events in the first 28 days following vaccination. “A better result than Moderna and Pfizer which had unwanted effects,” observed the scientific director of Spallanzani Giuseppe Ippolito to the presentation of the results of Phase 1.
GRAd-CoV2 is a single-dose, intramuscularly administered vaccine based on an adenoviral vector, the same technology used by AstraZeneca and Johnson & Johnson. It uses a gorilla adenovirus to transport the genetic information of the coronavirus S or Spike protein. It can be stored in a normal refrigerator.
The research and development activities of this vaccine have had the economic support of the government, the National Research Council and the Lazio Region. The state investments made by Invitalia, the government agency dedicated to the development of industrial projects, amount to 81 million euros, of which 69.3 to carry out phases 2 and 3 of the clinical study and the remainder to expand the plants of Roman Castle.
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