On September 21, the volunteer recruitment process begins, in Barranquilla and other cities in the country, for the third phase of the clinical study of the vaccine against Covid-19 that is developed by the pharmaceutical company Janssen.
This was reported by the National Institute for Food and Drug Surveillance (Invima), after evaluating the results corresponding to the study in phases 1 and 2, in which it was found that said vaccine offers the safety required to start the next phase.
Julio César Aldana, General Director of Invima, indicated that the clinical study will be carried out in ten research centers that position Colombia as one of the first countries that is ready to start.
“Invima, as a health authority and regulatory entity, can interrupt or request the modification of said phase at any time,” said the official, who specified that said measure can be taken in the interests of good clinical practices and the protection of human beings. humans participating in the aforementioned trial.
In the capital of the Atlantic, this clinical trial will be carried out in three research centers: Cimedical, the Hospital Universidad del Norte and the Clínica de la Costa, which were authorized by the health authority.
This last center received the endorsement recently, together with the Fundación Centro de Investigación Clínica (Medellín), Bluecare Salud SA (Bogotá) and the Pablo Tobón Uribe Hospital (Medellín).
process in cimedical. The Cimedical clinical research center has been holding a series of virtual talks with interested people to provide them with details about the clinical trial.
Andrés Jaller, manager of Cimedical, explained that they have a database of 415 interested parties, but that the goal is to have 800 volunteers in this research center, which has more than 20 years of experience in this type of research.
“It has been a process that has been well received, a significant number of people have shown their interest in participating in the trial and we are waiting for September 21 to begin to meet them in person,” said Jaller in dialogue with EL HERALD.
The manager of the clinical center recalled that people over 18 years of age with or without comorbidities can participate in the clinical trial. In addition, she recalled that each volunteer will receive six face-to-face visits during the two years that the study will be extended.
“The first will be at the time of the application of the vaccine, the second at a month. The third visit is scheduled at six months, while the fourth and fifth will be 12 and 18 months after the vaccination, respectively. The last one will be when they are two years old, ”said Jaller.
In addition, he stated that there are some exclusion criteria such as pregnant or lactating women, people with restrictions on some medications or serious medical complications.
The third phase of this study will be carried out, competitively, initially in six countries: the United States, Chile, Colombia, Mexico, Peru and South Africa, with a total population of 60,000 participants, distributed proportionally.
It should be noted that the pharmaceutical company that develops the drug is in charge of defining the countries participating in the study and the research centers in which it will be carried out.
The estimated primary completion date for the clinical trial is March 2023. Initial results are expected in January 2021.