This clinical trial will serve to find out if an additional dose of HIPRA's Covid-19 vaccine is capable of generating an immune response in people suffering from immune system disorders.
The biotechnological pharmaceutical company HIPRA has started a Phase III clinical trial of the vaccine against Covid-19 in immunocompromised people. This clinical trial, approved by the Spanish Agency for Medicines and Health Products (AEMPS), will serve to find out if an additional dose of HIPRA's Covid-19 vaccine is capable of generating an immune response in people suffering from immune system disorders. It will be studied whether the vaccine is capable of reactivating or generating again a sufficient immune response, increasing the activity of the immune system (natural defenses) against the virus. The safety of the new vaccine will also be studied and whether it can prolong the effect of the vaccination that the patient had previously received.
The study, which will take place in 3 hospitals in Spain and 3 hospitals in Turkey, will be made up of 400 people with primary immunodeficiency, HIV, kidney transplant or kidney disease, being on a dialysis program and people receiving treatment with Rituximab.
This clinical trial is led by HIPRA and is articulated through the European RBDCOV project.