What can we say about the Italian Spallanzani-ReiThera vaccine

There is another Italian vaccine, developed by Spallanzani together with the ReiThera company. The first data on 100 volunteers in phase 1, announced at a conference of the Lazio Region, are favorable. Here's what we know and the next steps of the trial

The Lazzaro Spallanzani Institute for Infectious Diseases (photo: Andreas Solaro / Afp via Getty Images) The more vaccines, the better against the new coronavirus. Italy and our country's research also stood out in the search for more vaccines: the Oxford-Astrazeneca vaccine, developed by the University of Oxford and the Irbm of Pomezia, is not the only one we are working on. Today, in fact, the first results of phase 1 (the first stage of the trial) of another vaccine, all Italian, developed by Spallanzani and produced by the biotechnology company ReiThera of Castel Romano, were announced in a conference at the Lazio Region. Phase 1 is now complete. In this first step on 100 volunteers, the drug, called Gr ad-Cov2, is safe even with a single dose instead of two and has not been associated with serious adverse reactions. However, caution is needed, since saying that the first results are favorable does not mean that the vaccine is ready, effective and that regulatory agency approval will soon arrive. It will in fact have to pass phase 2 and phase 3, even if the preliminary data bodes well for the possibility of obtaining another excellent product soon.



The objective, according to what was reported by the scientific director of Spallanzani Giuseppe Ippolito during the conference of 5 January, is to proceed with the experimentation and conclude phase 3 by the summer, and then submit the data to the evaluation by the European Medicines Agency (Ema) that if safety and efficacy are confirmed it will be able to approve it. "We aim to develop 100 million doses of vaccine per year," adds Antonella Folgore, president of the Reithera company. "The vaccine is stable at a temperature between 2 and 8 degrees".

The phase 1 study involved 100 volunteers, including 45 vaccinated and the others in the control group that received the placebo, and the the first vaccinations took place in August 2020. The vaccine currently works with a single dose, unlike others that provide two doses. Grad-Cov2 is currently safe and appears to induce a good immune response. Talking about efficacy and numbers is premature at the moment, however, given the low number of participants in the study which, we remember, is mainly focused on dosages and safety. For now, there has been no serious adverse reaction 28 days after administration.

Grad-Cov2 vaccine

Grad-Cov2 vaccine is based on the use of adenovirus ( also that of Oxford-Astrazeneca foresees the use of this kind of virus) taken from monkeys, in particular from gorillas, which are harmless to humans. Adenovirus is not only not dangerous but it is also very resistant so it is chosen as the carrier of the genetic information necessary for the production of the part of the coronavirus (the spike protein) against which the immune response is to be generated. In this way the body produces antibodies that deactivate the virus and block the advance of the infection. The vaccine is stable at a temperature between -2 ° C and -8 ° C and therefore could be stored easily. Different speech applies to the Pfizer-Biontech vaccine, currently in use also in Europe, which requires much lower temperatures.

The vaccine is developed by the ReiThera company, which is based near the city of Rome, in Castel Romano. The development took place with the support of the government, the National Research Council and the Lazio Region. Tests on the first volunteers, authorized by the Italian Medicines Agency (Aifa), are conducted at the Spallanzani hospital in Rome and at the Clinical Research Center in Verona. ReiThera, initially called Okairos, is a biotechnology company that deals with the development and early stages of clinical testing of viral vector vaccines, in particular adenoviruses of non-human origin. In 2013 Okairos was acquired by the Gsk group and changed its name to ReiThera.

What is phase 1 of the trial

The clinical trial involves drug testing under study on volunteers humans. In the first phase, the study of the drug is limited to a small sample of volunteers and the possible side effects are mainly evaluated. If the toxicity is acceptable and the benefit-risk ratio is in favor of the benefit, it is possible to move to phase 2. In this phase, on a larger sample of participants, the therapeutic activity and efficacy of the drug are also evaluated, as well as the best dosage. Then, in phase 3, which is extended to large numbers of participants, usually thousands, the safety and efficacy of the drug is evaluated and confirmed.

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