The Community of Madrid
begins from today the vaccination of the 150 participants from Madrid volunteers in the test clinical phase 2 of the first vaccine against him Covid-19 in Spain, from the pharmaceutical company Janssen, which was authorized on August 28 by the Spanish Agency for Medicines and Health Products.
The Madrid hospitals La Paz and La Princesa are, together with the Hospital Marqués de Valdecilla in Santander, the three centers participating in this clinical trial, which seeks to find the most appropriate dose and regimen to achieve the best antibody response. This trial will analyze a vaccine at an early stage, which is not usual in our country, and on a matter as relevant as prevention against Covid-19.
Specifically, the Madrid volunteers are 150 people (75 per hospital), 100 between 18 and 55 years old and 50 over 65 years, who, until September 22, will carry out the vaccination visit in the Clinical Trials Units, has informed the regional government in a statement.
This visit begins in parallel with the volunteer selection and screening visits that are still taking place at the centers. It is a phase 2 clinical trial, which will last between 14 and 16 months in total.
It is an early phase of the research, in which it is intended to evaluate which is the most appropriate dose and regimen in terms of activity to achieve the best antibody response (those that generate immunity against the virus), as well as to continue evaluating safety of the product under investigation.
Subsequently, phase 3, multicenter and multinational clinical trials will be necessary to demonstrate that the selected dose is safe and effective in preventing coronavirus infection.
The volunteers in whom the vaccine is going to be tested must be healthy people, without diseases or treatment, except in the group over 65 in which some type of mild disease can be assessed and that does not interfere with the possible results . Likewise, they should not have contact with people who are sick with Covid-19 or have had this disease.
This is a randomized clinical trial in which different treatment arms will be analyzed. In all cases, two punctures will be carried out in each patient, so that some patients will only receive a placebo, others one dose and another two doses of the investigational product.
Furthermore, it is a double-blind trial in order to prevent that the results may be influenced by the placebo effect or by observer bias.
The follow-up of patients will be carried out through several visits to the center, from the initial screening. After a first vaccination, a diary is given to the participants where they must note any adverse effects and the temperature recorded daily and go to the center weekly for the pertinent controls. After the second dose, visits as well as control calls and safety analyzes will be carried out.
The La Paz and La Princesa hospitals have modern Clinical Trial Units attached to their Health Research Institutes (IdiPAZ and IIS Princesa), accredited by the competent authorities with extensive experience in conducting clinical trials in healthy volunteers and patients.
In both cases, they strictly comply with the rules of Good Clinical Practice, ensuring at all times the safety of the participants in the different studies.
The fact that two Madrid hospitals are participating in this trial positions the region at a scientific level, the regional government has stressed. In this sense, Spain carries out an important work of clinical research and development of trials in early and advanced phases.
This trial is especially important, since it is going to analyze a vaccine at an early stage, which is not usual in our country, and on a very relevant issue for society at the moment such as the prevention of the population against Covid- 19.
This trial is especially important as you will be testing a vaccine at an early stage
Would you agree to participate in a trial of an experimental Covid-19 vaccine?
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