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The University of Chile began recruiting volunteers for the phase 3 study of the vaccine candidate from the pharmaceutical company Janssen, from Johnson & Johnson, in Chile.
Academics and researchers from the Faculty of Medicine of the public school will lead the clinical trial in three communes of the Metropolitan Region, which will begin this Friday, October 30, with the registration and immunization of the first participants.
It is expected that in the next sixty days health workers and people from the community will be vaccinated, who will be monitored for the next 25 months (with up to eight meetings with the clinical staff in charge), with the aim of certifying the effectiveness and safety development.
“It is a large-scale task that demands the highest quality standards,” said Dr. Miguel O’Ryan, academic at the Institute of Biomedical Sciences (ICBM) of the public university and one of the leaders of the study by his Faculty of Medicine.
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Recruitment of volunteers
Those interested in participating as volunteers should only call toll-free at +56 9 99329941 or +56 9 99057078, write to the email [email protected] or visit www.ensemblestudy.com. They will then be contacted to start the process.
Some of the requirements are to be over 18 years old and to be in good health. In case of having pre-existing conditions, these must be with stable and controlled parameters. The volunteers –who will enroll in the Colina and San Bernardo family health centers, and the Exequiel González Cortés hospital– can also come from regions and will receive payment for mobilization.
60 thousand individuals worldwide
The American company, a subsidiary of Johnson & Johnson, will evaluate the development in more than one hundred health centers worldwide, with about 60 thousand individuals enrolled.
Janssen’s COVID-19 candidate vaccine leverages the platform of its AdVac technology, which was also used to develop and manufacture the Ebola vaccine (from the same North American pharmaceutical company and approved by the European Commission), and build its candidate vaccines against it. Zika, VCR (rubella) and HIV.
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Unlike phases 1 and 2 (conducted in Belgium and the United States), the final clinical trial contemplates the administration of only one dose through an intramuscular injection. This is a randomized (randomized) study, in which some patients will receive placebo doses.
According to Dr. O’Ryan, the bases of this solution are the same that have allowed the vaccination of around one hundred thousand people in different diseases in recent years, including Ebola. “This experience, added to the results of the initial phases, provide some reassurance regarding the safety bases of the vaccine.”
Follow-up of volunteers
Janssen’s covid-19 candidate vaccine – also known as Ad26.COV2.S – is a development based on adenovirus vector 26, which was initially evaluated along with seven other previous immunizations. Of these, this was the one that obtained the best results at the level of neutralizing antibodies in macaques, according to a study published in Nature, which was the starting point to enter the race against the new coronavirus.
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The North American firm has called the study in phase 3 ENSEMBLE
Dr. Miguel O’Ryan, a pediatric infectologist who has participated in large-scale clinical studies in Latin America, including the rotavirus vaccine, details that all volunteers must be over 18 years of age. A significant percentage of the group will be healthcare workers, and others will come from a wide diversity of men and women in the community.
Trial participants must report data for the next 25 months. They will also be followed up to see the evolution of their immune response over time, with controls every four months. In case of contracting the infection, a special monitoring protocol will be carried out, according to the researcher.
“Before vaccination, blood samples are taken to see the immunological parameters of the person, and after being immunized, a more intense follow-up is followed for a couple of weeks, to evaluate the reactogenicity or response to vaccination in the different sub groups. People maintain permanent communication with the study teams to analyze local or systemic reactions to the vaccination ”.
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To do this, volunteers must report symptoms eventually related to a possible infection. “If it is found that the volunteer contracted the disease, a careful monitoring is done during this period with a record of his symptoms to assess the severity of the condition,” details the academic from the Faculty of Medicine of the University of Chile.
One of the objectives of the research, emphasizes Dr. O’Ryan, is to compare the infection rate between the vaccinated and the non-vaccinated, as well as whether the conditions presented may be less severe in the case of those who were immunized in relation to those who received the placebo. In Chile, the profile of the volunteers will be men and women over 18 years of age, who at the time of enrollment must sign an informed consent.
“Indeed, the person who participates are volunteers willing to participate, with informed consent, with absolute freedom to participate and to withdraw from the project at any time. There is absolute respect for the volunteer who quite altruistically decides to participate in clinical trials. And those who do not wish to participate their decision is respected. They are procedures that are carried out in the same way all over the world ”.
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Contribution to global development
Dr. Miguel O’Ryan confirms that they expect to complete the vaccination of all volunteers within 45 to 60 days. It is, in his opinion, a fundamental milestone in the process of developing an immunization that ends the pandemic, which in nine months has affected more than 30 million people.
“Clinical trials are essential to show that a vaccine is going to be effective and safe. Without these studies, there is no vaccine. The clinical trials in phase 1 and 2, where safety is mainly seen, were carried out in the United States and Belgium, with North American and European populations, and the phase 3 are larger, and are beginning with a significant presence from Latin America. We are all being part of a global development ”.
The trial will include people with and without comorbidities associated with an increased risk of progression to severe covid-19, and will seek to recruit participants from Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
Diversity in studies
The worldwide research project, which required an investment of US $ 1.5 billion, is financed with federal funds from the United States Office of the Biomedical Advanced Research and Development Authority (Barda). The company noted that the study phase 3 SET includes diversity criteria that are fundamental to evaluate effectiveness and safety.
In the United States, for example, the research includes representation of participants from the African American and Latino community. Phase 1 and 2 studies, adds the biotechnology, include adult patients, men and women, from 18 years to the third age. Dr. Miguel Oryan highlighted that this diversity of groups in the study is valuable to know the impact of infection and immunization in them.
“Covid-19 has disproportionately impacted both older people and certain at-risk populations. Therefore, clinical research studies often require a large and diverse number of volunteers, sometimes thousands are needed to obtain reliable information. This helps to ensure that drugs and vaccines are generally safe and work for different types of people, especially those most affected by the disease ”(By: Luis Francisco Sandoval. Inés Llambías Comunicaciones Agency).
Meanwhile, waiting for the final authorization delivered by the Institute of Public Health (ISP), the Ethics Committee of the Faculty of Medicine of the public campus approved this afternoon the trial, in phase 3, to begin in the coming days the enrollment of volunteers. The prototype of the University of Oxford and AstraZeneca, which will be tested in 4 centers in the country, joins another initiative led by the University of Chile, together with the pharmaceutical company Janssen, which begins the inoculation this Friday.
The trial intends to enroll more than three volunteers, with no age limit, in order to start the tests with the aim of obtaining a vaccine against the coronavirus. It is expected that within three weeks, recruitment for the prototype developed by the University of Oxford and AstroZeneca, led in our country, by the University of Chile, will begin.
AZD1222, this is the name of the third vaccine that has already been approved by the Ethics Committee of the Public School of Medicine, one of the 3 studies in which it is actively participating, and that is ready to be tested for Phase tests 3.
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“We will start by offering the possibility of voluntarily participating in this vaccination to health personnel, but not restricting it only to them, because people who work in essential positions are also considered a population at risk, and even any user of public transport that moves around the city of Santiago ”, says María Elena Santolaya, an academic at the Faculty of Medicine of the University of Chile.
Only those who have contracted Covid-19 and have positive PCR diagnostic confirmation cannot be included; thus, among those enrolled there could be “people who have had the infection but were asymptomatic”, clarifies.
The four centers that will be part of this study, which will begin in the next few days, are: the North Campus of the Faculty of Medicine of the U. de Chile, the Las Condes Clinic, a center in Quillota and the Luis Calvo Mackenna Hospital .
The vaccination will be carried out in two doses, separated by a month, and prior to each one of them, blood samples will be obtained, to determine the basal level of antibodies before starting and, later, to see the immune response produced by the first dose. and then for the second, in addition to other blood samples that will be taken during the two years of follow-up.
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