From this Monday the 190 volunteers will pass through the Madrid hospitals of La Paz and La Princesa, and in the Marqués de Valdecilla de Santander
Spain will begin this Monday, September 14th, with the first clinical trial for the COVID vaccine in phase 2, in humans, developed by the pharmaceutical company Janssen in the Madrid hospitals of La Paz and La Princesa, and in the Marqués de Valdecilla of Santander. Janssen's vaccine will be tested in 190 volunteers from two groups, one aged 18 to 55 and one aged 65 and over, and this phase 2 trial will last between four and six months.
In La Paz and La Princesa, 75 volunteers have been selected and 40 in Santander, who will begin to provide the first doses to all study participants from this Monday until September 22nd
Being healthy, not having had COVID-19 and accepting conditions for a clinical trial have been the requirements of these volunteers to test the vaccine. The pharmaceutical company assures that the preclinical results "have shown that it gives very good protection against the coronavirus because it prevents the replication of the virus at different levels of the respiratory tract."
Alberto Borobia, researcher at the Clinical Pharmacology Service and the Central Unit for Clinical Research and Clinical Trials (UCICEC) of the Hospital de La Paz, pointed out that once the two doses have been given to all volunteers, low doses of vaccine are administered «to simulate an infection and evaluate whether or not the organism of the volunteer generates neutralizing antibodies against those antigens that have been injected.
"You do not cause an infection since it is a vaccine that is not from a virus, it is not from the attenuated virus, which is a genetically modified organism, it is an adenovirus in which one of the proteins of the virus is inserted into one of its sequences ” explained Borobia, who commented that this entire procedure lasts 14 and 16 months.
Under normal conditions, the conclusion of phase 2 of the trial would be awaited for phase 3 to begin, which consists of evaluating the efficacy of the drug, and the period for the vaccine to be ready would be "between one and two years" . In addition to Spain, the trial will take place in two other European countries, Belgium and Germany. Phase 1 has been done in the United States and Belgium. A total of 550 healthy volunteers from the three European countries will participate to evaluate the range of doses and the different administration guidelines.
This vaccine, called Ad26.COV2.S, uses a technology based on a non-replicative recombinant adenovirus to generate an immune response against one of the coronavirus proteins.
Trials are essential to guarantee the quality, safety and efficacy of vaccines, the Ministry of Health reported in a statement..