Eight health centers in Madrid, Barcelona and Pamplona will apply the two punctures of rigor of the phase III test of the Janssen vaccine against him coronavirus. The international study, designed to evaluate the safety and efficacy in healthy people with previous illnesses of the main vaccine candidate of the multinational Johnson & Johnson, will begin “not before December”, according to company sources, and will do so with the selection of volunteers: around 2,000 in Spain (although this is a figure that may still vary).
How many volunteers are needed?
In total, a total of 30,000 volunteers from nine countries will participate in this trial, including Spain, Germany or the United States. There is no “quota” of volunteers closed for each one of them, since the recruitment is competitive. That is, it depends on the capacity of each health center that is part of the study and, as they enroll participants, places will be subtracted from that total of 30,000. Even so, according to the documentation sent to the Spanish Agency for Medicines and Health Products (Aemps), the initial estimate is that Spain will recruit around 2,000 volunteers.
In which hospitals is it going to take place?
In the authorization of the Aemps they appear eight centers in Spain in Madrid, Barcelona and Pamplona. They are the University Clinic of Navarra (Pamplona); the Hospital Clinic of Barcelona; the Quironsalud Hospital in Barcelona; the Germans Trias i Pujol University Hospital in Badalona (Barcelona); the Vall D’Hebron University Hospital (Barcelona); the Hospital Universitario de la Princesa (Madrid); the La Paz University Hospital (Madrid) and the QuironSalud University Hospital in Madrid.
Who can volunteer?
At this time, we are looking for participants between 18 and 60 years old on the one hand, and over 60 for another. 20% of the patients will be under 40 years old, and 30% over 60 years old. The participant must present a good or stable state of health, and have a BMI less than 30 kg / m2.
In the first stage of the trial, those people who do not have diseases that can aggravate the evolution of Covid (such as obesity), but who do may have underlying diseases, as long as your symptoms and signs are stable and well controlled. If participants receive medication for a condition, the dose of the medication must have been stable for at least 12 weeks.
Furthermore, in a second stage of the same study, the participant can present diseases with risk to aggravate Covid, but provided that it is stable and well controlled (for example, it would be the case of a stable / well controlled HIV infection). If participants receive medication for concomitant illness, the dose of medication must have been stable for at least 12 weeks prior to the first vaccination and should be expected to remain stable throughout the study.
For what reasons can I be excluded?
Reasons potential candidates are excluded include having allergies known or history of anaphylaxis; have received an investigational drug or have abnormal function of the immune system due to autoimmune diseases or chronic kidney disease requiring dialysis. However, participants with stable clinical conditions on non-immunomodulatory therapy (eg, autoimmune thyroiditis or autoimmune inflammatory rheumatic disease, such as rheumatoid arthritis) may be enrolled at the investigator’s discretion.
When does the recruitment start?
It will depend on each health center, but sources from Janssen suggest that not before december. Also sources from the University Hospital of La Paz, which will coordinate the trial at the national level, explain that they do not plan to start immediately, and that they will do it “in a week or two”. For now, the recruitment protocol has not been published, but in the previous trial, the one related to phase 2 of the same vaccine (which is carried out in three Spanish centers), each center used a telephone and an email so that potential volunteers made the first contact.
Does participating in the study ensure the vaccine?
Throughout the trial, both the vaccine and a placebo masked (that is, the naked eye will not be distinguished from the real vaccine) and until the trial is over, the volunteers will not know what they have been put on. However, volunteers who have received placebo are usually given priority during vaccination.
Is there an economic compensation?
Like any clinical trial, you will receive financial compensation for the expenses derived from participation. In the phase 2 trial of this same vaccine, this compensation did not exceed 70 or 80 euros per day.
Does anyone assure me if there is any damage?
European legislation establishes that “in clinical trials, you must ensure compensation for damages when successfully requested in accordance with applicable law. Therefore, Member States should ensure that there are mechanisms for compensation for damages suffered by a test subject that are commensurate with the nature and extent of the risk. ‘