From gorilla adenovirus the made in Italy vaccine being tested from today

Share

The test on the all Italian vaccine starts today at the National Institute for Infectious Diseases Lazzaro Spallanzani in Rome. It is called GRAd-COV2 and is developed by the biotech company Reithera based in Castel Romano (Rome), with the support of the Government, the National Research Council and the Lazio Region. The tests on the first 90 volunteers were authorized by the Italian Medicines Agency (Aifa) and will be conducted not only at Spallanzani, but also at the Verona Clinical Research Center. This is a phase I study which aims to evaluate safety and immunogenicity, i.e. the ability to provoke an immune response to the virus.

The made in Italy vaccine is based on a gorilla adenovirus, which aims to "transport" a sequence of genetic code that causes the reaction of our immune system and pushes it to develop antibodies. In particular, the target of GRAd-COV2 is the Spike protein that the coronavirus SarsCov2 uses to attack human cells.

The gorilla adenovirus, unlike the human ones, is not immediately recognized by the human immune system and, therefore, has enough time to carry out its "mission". GRAd-COV2 is a preventive vaccine which, when injected intramuscularly, would be able to stimulate the production of antibodies and the activity of immune cells. If this trial is successful, we will continue with the subsequent phase II and III clinical studies, in which the number of healthy volunteers will be expanded to confirm safety and then also demonstrate the efficacy of this vaccine.

The experimentation will be carried out on ninety volunteers divided into two age groups: 45 between 18 and 55 years, as many over the age of 65. Each group will be divided into three subgroups of 15 people, each of whom will be given a different dosage of the vaccine preparation. Reithera Srl, a company based in Castel Romano, creator of the vaccine, was established in 2014 by a group of Italian researchers who had devised the use of the chimpanzee adenovirus as a "spacecraft" on which to graft the genetic material necessary to make vaccines against infectious diseases such as Hepatitis C, malaria, respiratory syncytial virus, and Ebola. Based on this experience, Reithera developed the new viral vector, GRAd32, by isolating a gorilla adenovirus which in preclinical studies induced a strong immune response, both humoral and cellular, against the proteins carried, also demonstrating a good safety profile.

Through sophisticated techniques this virus, absolutely harmless to humans, has been modified to eliminate its replication capacity; then the SARS-CoV-2 protein S gene, the main target of human-produced antibodies when the coronavirus enters the body, was inserted into it. Once injected into people, this modified virus, or rather the protein S it carries, will cause the body's immune system to respond - the production of antibodies capable of protecting against the SARS-CoV-2 virus.

Other primate-derived adenoviral vector-based vaccines have already been evaluated in Phase 1 and 2 clinical trials for vaccine candidates for other infectious diseases, proving to be safe and to generate consistent immune responses even with a single dose of vaccine.