Spanish Medicines and Health Products Agency authorises the first clinical trial of a Spanish vaccine against COVID-19

The Spanish Agency for Medicines and Health Products (AEMPS) has authorised the clinical trial of Hipra's PHH-1V vaccine against COVID-19. This is the first human trial of a vaccine developed in Spain.

It is a phase I/IIa dose-escalation, randomised, controlled and blinded trial (Hipra vaccine or a licensed vaccine is administered blinded in a way that prevents its identification by both the patient and the research team), which will mainly study the safety and tolerability of this vaccine, as well as its immunogenicity and efficacy as secondary objectives. For this purpose, several dozen volunteers will be recruited from hospital centres who will start the process of selecting volunteers who meet the inclusion criteria specified in their protocol as soon as possible.

This vaccine is based on two structurally similar recombinant proteins, one corresponding to the alpha variant and the other corresponding to the beta variant, which are joined together to form a unique structure called a dimer, and which are accompanied by an adjuvant that enhances the immune response. This combination is able to generate an immune response against one of the SARS-CoV-2 virus proteins, known as the S (spike) protein. This platform is the same as that used for the Novavax and Sanofi/GSK vaccines, which are already under evaluation for potential licensing by the European Medicines Agency (EMA), but unlike them, it expresses proteins from two different variants.

The study will divide the volunteers into groups (cohorts) and will start by administering the lowest dose to the first cohort. Following evaluation of the safety data of these participants by an independent monitoring committee, they will be escalated to subsequent doses if no safety concerns are identified. This practice - common in this type of trial - is aimed at assessing the optimal vaccine dose. Each participant will receive two doses 21 days apart.

Close monitoring of all volunteers and identification of all cases of adverse events and SARS-CoV-2 infection as they occur will be carried out throughout the trial. This will allow preliminary analyses to be carried out with intermediate data that will allow further research to be performed. However, it will be necessary to wait until the clinical trial is completed before all the data can be analysed and final conclusions drawn.

These clinical trials are part of the requirements for all investigational vaccines to demonstrate their quality, safety and efficacy. Only after they have been evaluated and meet regulatory standards will they be authorised for use.

The Ministry of Health and the Ministry of Science and Innovation are in contact with other research groups developing COVID-19 vaccines in Spain to support them in the regulatory process and facilitate the process, while ensuring that these vaccines have all the guarantees of quality, safety and efficacy necessary to be finally authorised.

Non official translation