The ENSEMBLE 2 trial will evaluate the efficacy and safety of Janssen’s vaccine and will include 30,000 volunteers from 9 countries. In Spain, this will be done in 9 hospital centers. Only after a favorable assessment of the balance of benefits and risks can it be commercialized on European territory.
Spanish Agency for Medicines and Health Products (Emergency action plan)Authorized Phase III clinical trial in Spain From COVID-19 vaccine From the company Jensen (A Johnson & Johnson subsidiary). This is the first phase III trial of a vaccine authorized by our country.
it is Critical, transnational, double-blind trial -Masking should be added when vaccinating or placebo to prevent them from being recognized by the naked eye. -The vaccine or placebo will study the safety and effectiveness of the two-dose regimen of the vaccine.
For this, until 30,000 volunteers from 9 countries/regions (Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States).The trial will be at Nine Spanish hospitals They will start recruiting volunteers who meet the inclusion criteria stipulated in their agreement as soon as possible.
The study will be vaccinated first Participants without comorbidities It is associated with an increased risk of developing a severe coronavirus. After an independent committee evaluates the safety of these volunteers, it will include individuals with concomitant diseases associated with an increased risk of disease progression.
A kind 20% of patients will be under 40with 30% over 30 years old. During any trial period, all volunteers will be closely monitored and all Covid-19 cases that have occurred will be identified. According to AEMPS, “you must wait until the clinical trial is completed before you can analyze all the data and reach a final conclusion.”
Another step towards an effective vaccine
These clinical trials are part of the requirements that all experimental vaccines must perform to prove their quality, safety, and effectiveness. They can only be authorized for commercialization after they are evaluated and meet the regulatory standards.
This vaccine is called Ad26.COV2.S, Based on a non-replicating recombinant adenovirus technology, which can generate an immune response against a coronavirus protein called Protein S (From spike, Also called needle-shaped protein in Spanish).
This Ministry of HealthThrough AEMPS, it keeps in touch with a number of companies that have proposed to include Spanish research centers in their clinical trials, thus contributing to the long-awaited global research on coronavirus vaccines.