Science Minister announces progress made with the Janssen vaccine clinical study in Chile
The medical team in charge of the Phase 3 clinical trials of the vaccine developed by Johnson & Johnson gave a presentation at Dr. Exequiel González Cortés Hospital to explain the different phases that the clinical trial will pass through. So far 600 volunteers have already been recruited in Chile. Minister Andrés Couve thanked the scientific community for its participation in this international effort and highlighted that each of the clinical phases will follow the maximum safety standards.
Within the framework of the government’s integrated Covid-19 Vaccine Strategy, Science Minister Andrés Couve visited the Dr. Exequiel González Cortés Hospital, one of three healthcare centers in the Metropolitan Region where Universidad de Chile teaching staff and researchers are participating in the Janssen vaccine Phase 3 study developed in collaboration with the Johnson & Johnson vaccine developer.
Dr. Rodolfo Villena, the director of the clinical trial at the hospital, was the guide during the visit. He described the different phases of the study: the process of recruiting volunteers; interviewing the participants, who then sign an informed consent form; the preparation of the vaccines using masked syringes; the double-blind system; and the follow-up of vaccinated patients over a period of two years using an app called Study Hub.
“We are meeting the commitment made by the Science Ministry, along with the scientific community and the Covid-19 Vaccine Committee, to conduct three clinical trials and we´re waiting to begin a fourth one,” Minister Couve said. He explained that the clinical trials are “being conducted at an accelerated pace so that a vaccine can be ready in 12 to 18 months’ time. This involves working quickly without skipping any steps because the data from each clinical trial phase has to be analyzed in accordance with strict criteria and safety standards.”
After obtaining approval from the Institute of Public Health to test the vaccine on patients, the Janssen vaccine Phase 3 study was the first clinical trial to start vaccinations in Talca on October 28... At present, the vaccinations are taking place in three municipalities in the Metropolitan Region: the family medicine centers in Colina, San Bernardo and the Dr. Exequiel González Cortés Hospital. To date, the trial led by the Universidad de Chile has recruited over 350 participants in the Metropolitan Region and close to 600 volunteers nationwide.
“It’s a big challenge to have the opportunity to take part in something that can mark a milestone in the history of medicine. By joining forces, we are able to work towards obtaining a product that can stop the pandemic less than 12 to 18 months after its onset. Also we’ve seen how this has had an impact on many people and many of them have felt the need to collaborate. There’s a general feeling of working together to try to resolve a problem between us all,” Dr. Villena said
Dr. Villena also explained that people wishing to take part in the study must be adults aged 18 and over, and in good health. If they have pre-existing conditions, they must be within stable parameters and under control. “The selflessness of the volunteers who have arrived makes one feel even more motivated to continue working with a highly demanding protocol that combines new vaccine development platforms but also new methods and applications that allow us to do follow-up remotely without exposing individuals to frequent hospital visits,” he said.
Dr. Miguel O’Ryan, who is a member of the Covid-19 Vaccines Committee and is overseeing the Janssen study in the Metropolitan Region from the Universidad de Chile, said that the recruitment of volunteers will be finalized by the end of the year. He explained that the response “of young participants has been very enthusiastic but there has been more reluctance among older adults, who are welcome to join.”
Those interested in participating as volunteers are asked to call +56 9 99329941 or +56 9 99057078 or write to estudiojanssen@med.uchile.cl or visit www.ensemblestudy.com and they will be contacted to begin the process.