The Ministry of Health has authorized human trials of a Spanish vaccine against COVID-19

The Ministry of Health has given free rein to the first human trials of one of Spain’s COVID-19 vaccines. This is the PHH-1V vaccine against COVID-19, from the company Hipra.

Authorization of this vaccine 11 days after the end of the vaccine tests of the Higher Scientific Research Center (CSIC), without the causes of the problem having yet been revealed this forced to stop the phase of testing in humans.

Phase I / II dose escalation of the newly authorized PHH-1V vaccine against COVID it will be done by a random, controlled and “masked” process. That is, the vaccine is administered in tests or other authorized test, so that neither the recipient nor the scientific team can identify which one each person has received. In this first step, the level of safety of the drug will be studied, as well as the level of tolerance to it and the immunity that it manages to create.

The phase of volunteer recruitment it will start immediately. People who have not had the disease and have not received other vaccines will be selected. The people selected will constitute two cohorts. The first will receive a very low dose of the vaccine. Once the results are obtained, the dose will be increased to the necessary level.

The Ministry of Health says that “it will be necessary to wait until the end of the clinical trial to be able to analyze all the data and draw definitive conclusions” before moving on to a new phase of testing with a larger number of population. The first groups will be made up of 100 to 200 people.

This vaccine is based on two structurally similar recombinant proteins, one corresponding to the alpha variant of Covid-19 and another corresponding to the beta variant. The two come together to form a unique structure, called a dimer, which, together with an adjuvant, increases the immune response. The combination of the two variants in a single vaccine generates an immune response against the S protein, one of which is contained in the SARS-CoV-2 virus.

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