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01/02/2022

Recruitment of volunteers starts for the Phase III clinical trial of the HIPRA COVID-19 vaccine

Assaig clínic Fase III HIPRA

01/02/2022

The trial, which already has AEMPS authorisation, will be conducted in Spain, Portugal and Italy.

A total of 20 hospitals, including Vall d’Hebron, have started calling for volunteers to take part in the phase III trial of the COVID-19 vaccine developed by the biotechnology pharmaceutical company HIPRA. The Spanish Agency of Medicines and Medical Devices (AEMPS) has authorised the phase III clinical trial to start once the phase IIb trial showed good tolerability, a good safety profile and a powerful response to the variants, including omicron. This is the last phase of the clinical trial before marketing the vaccine.

In phase III, which will involve 3,000 people aged over 16, assessment of the safety and efficacy of the HIPRA booster dose against COVID-19 will continue in a larger group of people who have received different vaccines (AstraZeneca, Moderna, Pfizer and Janssen): This study aims to confirm that reinforced immunisation with the HIPRA vaccine can broaden protection to cover new variants and prolong the preventative effect of vaccination. The volunteers will be followed for a year to assess long-term safety and the immune response.

People who wish to participate must have received one or two doses of one of the authorised vaccines (Comirnaty (Pfizer), Spikevax (Moderna), Vaxevria (AstraZeneca), Janssen (Janssen) or combinations) at least 3 months before participating. Volunteers who have had COVID-19 in the last 1 month, without requiring hospitalisation, can also participate in the study. Each hospital has prepared a section on their websites for people interested in enrolling.

The trial is being assessed by the Hospital Clínic de Barcelona Ethics Committee and the AEMPS.

The HIPRA vaccine

The HIPRA vaccine against COVID-19 is an adjuvanted multivariate recombinant protein-based vaccine, based on s receptor binding domain (RBD) fusion heterodimer that contains the B.1.1.7 (alpha) and B.1.351 (beta) SARS-CoV-2 variants.

The HIPRA vaccine can be kept at refrigerator temperature (2 to 8º C), thus simplifying storage and distribution. In addition, the technology used provides significant versatility in adapting to new variants of the virus, should this be necessary in the future. The results obtained so far show that the vaccine produces neutralising antibodies against current variants of concern (VOCs) and is effective in preventing the disease.

Twenty hospitals to participate in the phase III trial

The HIPRA vaccine phase III trial is being conducted in different public and private hospitals in Spain (17), Portugal (2) and Italy (1):
Hospital Germans Trias i Pujol (Badalona, Catalunya); Hospital Clínic de Barcelona (Barcelona, Catalunya); Hospital Vall d’Hebron Barcelona Hospital Campus (Barcelona, Catalunya); Hospital Universitari de Girona Doctor Josep Trueta (Girona, Catalunya); Hospital de Mollet (Mollet, Catalunya); Hospital Universitario de Cruces (Barakaldo, Euskadi); Hospital Universitario La Paz (Madrid, Comunidad de Madrid); Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Comunidad de Madrid); Hospital General Universitario Gregorio Marañón (Madrid, Comunidad de Madrid); Hospital HM Nou Delfos Barcelona (Barcelona, Catalunya); Hospital Universitario HM Montepríncipe (Madrid, Comunidad de Madrid); Hospital Universitario HM Sanchinarro (Madrid, Comunidad de Madrid); Hospital Universitario HM Puerta del Sur (Móstoles, Comunidad de Madrid); Hospital Universitario Quironsalud Madrid (Madrid, Comunidad de Madrid); Hospital Quironsalud Barcelona (Barcelona, Catalunya); Hospital Regional Universitario de Málaga (Málaga, Andalucía); Hospital Clínico Universitario de Valencia (Valencia, Comunitat Valenciana); Hospital Univ. Minho Braga (Braga, Portugal); Hospital Algarve Biomedical Center (Algarve, Portugal); Hospital Niguarda (Milano, Itàlia).

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