The first phase-2 coronavirus clinical trial on human beings in Spain gets underway on Monday, with the pharmaceutical company Janssen in charge of development at La Paz and La Princesa Hospitals in Madrid and Marquis of Valdecilla Hospital in Santander.
La Paz and La Princesa have delayed the start of the trial until Tuesday due to laboratory problems, but the Santander trial is underway.
The Janssen vaccine is being tested on 190 volunteers from two groups, one composed of people aged 18 to 55 and the other with people 65 and over.
The trial will last 4-6 months with 75 volunteers in Madrid and 40 in Santander.
The criteria for clinical trial volunteers includes, being healthy, not having Covid-19 and accepting the conditions of the vaccine trial.
“Pre-clinical results have shown that it provides very good protection against coronavirus because it stops the replication of the virus at different levels in the airways,” said Janssen.
“Two doses are given to all volunteers, then low doses of vaccine are administered to simulate an infection and assess whether or not the volunteer's body generates neutralising antibodies to the antigens that have been injected,” explained Alberto Borobia, who’s a researcher at the Clinical Pharmacology Service at the Central Unit for Clinical Research and Clinical Trials, or UCICEC at La Paz Hospital.
"You don’t cause an infection because it’s a vaccine that is not a virus, it is not an attenuated virus,” he stressed. "It is a genetically modified organism, it is an adenovirus in which one of its proteins is inserted into one of its sequences,” he said, adding that the whole procedure lasts 14-16 months.
Under normal conditions, phase 2 of the vaccine trial finishes before the beginning of phase 3, when the efficacy of the drug is evaluated and the vaccine would be usually ready “between one and two years” after that.
Vaccine trials are also taking place in Belgium and Germany and Phase 1 has already been completed in the United States and in Belgium.
A total of 550 healthy volunteers from Spain, Belgium and Germany will participate in the trials to evaluate the range of doses and the different Administration guidelines.
The Ad26.COV2.S vaccine uses a technology based on a non-replicative recombinant adenovirus to generate an immune response against one of the coronavirus proteins.
The Ministry of Health said in a statement that vaccine trials are essential to guarantee quality, safety and efficacy.