The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the PHH-1V vaccine clinical trial against the company’s Covid-19 Hipra. This is the first human trial of a vaccine developed in Spain.
It is a phase I / IIa trial dose escalation, randomized, controlled and masked (the Hipra vaccine or an authorized vaccine is administered masked, so as to prevent 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 targets. As reported this Wednesday by the Ministry of Health, several dozen volunteers between the ages of 18 and 39 will be recruited that they will start, as soon as possible, the process to select volunteers who meet the inclusion criteria specified in their protocol.
This vaccine is based on two structurally similar recombinant proteins, one corresponding to the alpha variant and another corresponding to the beta variant, which unite to form a unique structure called a dimer, and which are accompanied by an adjuvant that increases the immune response. This combination is capable of generating a immune response to one of the SARS-CoV-2 virus proteins, known as protein S (from spike, also called spike protein in Spanish).
This platform is the same as that used for the Novavax and Sanofi / GSK vaccines, which are already in the process of being evaluated for their potential authorization by the European Medicines Agency (EMA), but to Unlike them, it expresses proteins of two different variants.
In the study the volunteers will be divided into groups (cohorts) and the lowest dose will be administered to the first cohort. After evaluation by an independent surveillance committee of the safety data of these participants, they will be escalated to the next doses if no safety problems have been detected. This practice -common in this type of essay- is aimed at evaluate the optimal dose of vaccine. Each participant will receive two immunizations 21 days apart.
During any trial, close monitoring of all volunteers and identification of all cases of adverse events and SARS-CoV-2 infection that occur will be carried out. This will allow carrying out preliminary analyzes with intermediate data that allow to continue advancing in the investigation. However, it will be necessary to wait until the clinical trial has finished in order to analyze all the data and draw final conclusions.
These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate its quality, safety and efficacy. Only after having been evaluated and if they comply with regulatory standards will they be authorized for commercialization.
Hipa’s is not the only Spanish vaccine underway. The Ministry of Health and the Ministry of Science and Innovation maintain contact with other research groups that are developing vaccines against Covid-19 in Spain, they say in a statement.