The Josep Trueta de Girona and Clínic de Barcelona hospitals begin screening volunteers who will participate in the clinical trial with humans of the first Spanish vaccine against covid , which is being developed by the Hipra laboratory.
On August 11, the Spanish Agency for Medicines and Health Products (Aemps) authorized the first clinical trial in people of a Spanish vaccine against covid-19, the PHH-1V vaccine from Hipra, a laboratory that has its plant in Amer ( Girona).
After concluding with remarkable success this week the admission of volunteers, as hospitals received dozens of calls and emails from people who showed interest in the test, the selection of the most suitable to participate in the clinical trial will now begin.
In this first phase, thirty people from 18 to 39 years old who have not suffered the disease or been vaccinated against it will be chosen , and in the coming weeks they will be inoculated with doses of the new vaccine.
In the study, volunteers will be divided into groups (cohorts) and the lowest dose will begin with the first cohort.
After evaluation by an independent surveillance committee of the safety data of these participants, they will be escalated to the next doses if no safety problems have been detected.
Each participant will receive two immunizations 21 days apart , according to Aemps.
Throughout the trial, close monitoring of volunteers and identification of cases of adverse events and SARS-CoV-2 infection that occur will be carried out.
This will make it possible to carry out preliminary analyzes with intermediate data that will allow us to continue advancing the investigation. However, it will be necessary to wait until the clinical trial has finished in order to analyze all the data and draw conclusions.
Subsequently, in October, the most appropriate dose to be applied in humans will be established and a study will be carried out with many more people in different health centers in Spain and, possibly, Portugal and Italy.