The AEMPS authorizes the phase I/IIa clinical trial of the HIPRA Covid-19 vaccine
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the phase I/II clinical trial of the HIPRA Covid-19 vaccine from the Hipra company, headquartered in Amer, Catalonia. Its about first trial in people of a vaccine against SARS-CoV-2 developed in Spain. The team that the multinational company has in its R&D center at the Barcelona Science Park – where part of the research for the design, generation and characterization of new vaccine antigens is carried out – is actively participating in the project.
The trials are scheduled to begin in mid-August at the Hospital Clínic de Barcelona and at the University Hospital of Girona Doctor Josep Trueta with a group ofr volunteers aged between 18 and 39 who have not received any COVID-19 vaccine and who have not had the infection. In this first phase, the safety and tolerability of this vaccine will be studied mainly, as well as its immunogenicity and efficacy as secondary targets.
The HIPRA Covid-19 vaccine, developed by Hipra, is a recombinant protein vaccine designed to be very safe and induce a powerful neutralising immune response to the SARS-CoV-2 virus. It can be conserved at between 2 and 8ºC, thus facilitating the logistical process.
If the clinical trials prove successful, production will begin in October with the aim that new vaccine hit the market by early 2022, subject to obtaining the competent authorisations.