The first group of volunteers participating in Phase I / IIa of the trials of the vaccine against COVID-19 of the Catalan pharmaceutical company Hipra have already received the first doses. In total, around 500 volunteers between the ages of 18 and 39 will collaborate in this clinical stage of the study, where the safety of what could be the first Spanish vaccine against the disease caused by the coronavirus will mainly be verified.
Two weeks after the announcement by the Spanish Agency for Medicines and Health Products (AEMPS) that they were giving the green light to human trials of the drug, the Catalan company Hipra has begun to inoculate the product to the first 30 volunteers at the Hospital Universitario Clínic Barcelona and the Doctor Josep Trueta University Hospital of Girona. In addition to the injection, participants must fill out a questionnaire and take a blood test to know for sure that they have not previously passed COVID-19, one of the requirements – in addition to not being vaccinated – to participate in the tests.
Dr. Álex Soriano, head of the Infectious Diseases Service of the Hospital Clínic de Barcelona and head of the Nosocomial Infections Group of the August Pi i Sunyer Biomedical Research Institute (IDIBAPS), stressed the value of the project during a press conference held this Friday . “It is important because in the future new threats may appear”, not only new variants of the coronavirus, but also other different pathogens, with which it is significant “to have the technology and to be able to develop vaccines within the national territory. Also because this way we have more vaccines “added the expert, pointing out that there are still unvaccinated groups” that will probably require new doses or revaccination. ”
Phase I / IIa Process
The first participants in the trial have been randomly divided into two groups, one of them receiving a lower dose and the other a higher dose. The reason is that the researchers are not only looking to check the safety of the vaccine, but also its immunogenicity – what is known as ‘cellular response’ – and the necessary dose of the drug. But not everyone will receive the vaccine from the Catalan company: some will be administered drugs currently marketed at random. Neither the participants nor the experts will know which group received the trial vaccine.
Once the volunteers receive their doses, the monitoring process and the follow-up stage begin, which will last for a year in order to obtain conclusions and move on to the next phase of the project, if approved by the AEMPS. Regarding commercialization, the groups of scientists participating in the project have not wanted to establish a specific date, pointing out that it is a process that requires different phases and tests, as well as the approval of the Spanish Medicines Agency.
The Girona company Hipra is working on a vaccine with two recombinant proteins of the Alpha and Beta variants of the coronavirus that would induce an immune response to the so-called S protein orspike SARS-CoV-2, a technology similar to that used in the American Novavax. In addition, another of the outstanding characteristics of the project is that it is a product that can be stored between 2 and 8 degrees, which would facilitate its distribution and logistics. As the doctor from the Hospital Clínic Lorna Leal has indicated at a press conference, this drug has a series of advantages: the most notable is that it is a technology on which they have experience and confidence, which “gives security”. The expert also points out that it is a study first-in-human (Human first in English), making it a controlled trial whose “primary goal is safety.”