AEMPS authorizes phase III clinical trial of the HIPRA’s vaccine against Covid-19
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized phase III clinical trial of the vaccine against Covid-19 developed by the biotechnological pharmaceutical company HIPRA. A total of 20 hospitals from Spain, Italy and Portugal will participate in Phase III, which have already begun recruiting volunteers. Phase III begins once Phase IIb has shown good tolerability, a good safety profile, and a strong response against variants, including omicron. This Phase is the previous step necessary to submit an authorization request to the European Medicines Agency (EMA).
In Phase III, in which some 3,000 people over 16 years oldwill participate, the safety and efficacy of the booster dose of the HIPRA vaccine against Covid-19 will continue to be evaluated in a larger group of people vaccinated with different vaccines already authorized (AstraZeneca, Moderna, Pfizer and Janssen). This study aims to confirm that booster immunization with the HIPRA vaccine can extend protection against new variants and prolong the preventive effect of vaccination. The volunteers will be followed for one year to assess long-term safety and immune response.
People who want to participate in the trial must have received one or two doses of one of the licensed vaccines (Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), Janssen (Janssen) or combined) at least 3 months ago. In the event that people have passed the Covid-19 at least 1 month ago, without having been admitted to the hospital, they will also be able to participate in the study. Each hospital has enabled a space on its website so that interested people can register.
The study will be evaluated by the Ethics Committee of the Hospital Clínic de Barcelona and by the Spanish Agency for Medicines and Health Products (AEMPS).
The Covid-19 vaccine being developed by HIPRA is an adjuvanted recombinant protein vaccine, based on a receptor binding domain (RBD) fusion heterodimer containing variants B.1.1.7 (alpha) and B.1.351 (beta) of SARS-CoV-2.
The HIPRA vaccine is stored at refrigerator temperature (between 2 and 8ºC), facilitating storage and distribution. However, the technology used allows great versatility to adapt it to new variants of the virus, if necessary, in the future. The results obtained to date show that the vaccine produces neutralizing antibodies against current VOCs (variants of "concern") and is also effective in preventing the disease.
20 hospitals participate in Phase III
Different public and private hospitals located in Spain (17), Portugal (2) and Italy (1) participate in Phase III of the HIPRA clinical trial: Hospital Germans Trias i Pujol (Badalona, Catalonia); Hospital Clínic de Barcelona (Barcelona, Catalonia); Hospital Vall d’Hebron Barcelona Hospital Campus (Barcelona, Catalonia); Hospital Universitari de Girona Doctor Josep Trueta (Girona, Catalonia); Hospital de Mollet (Mollet, Catalonia); Hospital Universitario de Cruces (Barakaldo, Euskadi); Hospital Universitario La Paz (Madrid, Community of Madrid); Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Community of Madrid); Hospital General Universitario Gregorio Marañón (Madrid, Community of Madrid); Hospital HM Nou Delfos Barcelona (Barcelona, Catalonia); Hospital Universitario HM Montepríncipe (Madrid, Community of Madrid); Hospital Universitario HM Sanchinarro (Madrid, Community of Madrid); Hospital Universitario HM Puerta del Sur (Móstoles, Community of Madrid); Hospital Universitario Quironsalud Madrid (Madrid, Community of Madrid); Hospital Quironsalud Barcelona (Barcelona, Catalonia); Hospital Regional Universitario de Málaga (Málaga, Andalusia); Hospital Clínico Universitario de Valencia (Valencia, Valencian Community); Hospital Univ. Minho Braga (Braga, Portugal); Hospital Algarve Biomedical Center (Algarve, Portugal); Hospital Niguarda (Milano, Italia).