A Phase 3 scientific clinical study in Chile and the Philippines to evaluate and validate a quadrivalent vaccine against four influenza strains is currently under results review after immunizing two thousand people in my country and Asia . nation.
The vaccine was jointly developed with Sinovac’s laboratory and has a wider coverage than the vaccine currently used by the national immunization program. This scientific study was led in our country by researchers from the Millennium Institute of Immunology and Immunotherapy (IMII) and the Catholic University of Chile (UC).
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“Review of the results will allow us to determine how well flu vaccine evaluations performed in the different participating age groups (3 to 7 years, 7 to 17 years, 18 and over, and 65 and over). publications to analyze and communicate these results, to objectively evaluate the data obtained, and thus to draw conclusions about the possibility of implementing the tested vaccine in the population”, explains Dr. Pablo González, IMII researcher, academic and professor at the University of California. Director of the study. The The scientists emphasized that a relevant feature of the vaccine evaluated “is that it is quadrivalent, that is, it contains four strains of influenza virus and induces a broader response against the virus than the most common trivalent vaccine. Reaction. “
“In this multicentre study called Tetrafluvac, 2000 doses of influenza vaccine were administered in participating countries (Chile and the Philippines in particular). This type of study allows us to have a diverse set of participants and thus obtain results with a global component. The vaccination period begins before the onset of winter in 2023 to prevent the annual flu season, which occurs primarily in winter,” commented Alexis Kalergis, Ph.D., director of the Millennium Institute for Immunology and Immunotherapy, UC and tenured professor at UC. Academic Director of the study.
In Chile, volunteers have been involved in the University of California Clinical Research Center, the German Clinic, the San Sebastian University Health Center and Respiratory Medicine Research Center, the Metropolitan Region, and the Puerto Montt Regional Hospital. The IMII emphasizes that the study included people from cities other than San Diego, which provided greater heterogeneity in the population analyzed.
“The purpose of this study is to analyze and communicate these results through scientific publications, to objectively evaluate the data obtained and to draw conclusions about the possibility of implementing the tested vaccine in the population.” – Pablo Gonzalez Pablo González, University of California scholar, director of the study.
“Both public and private health institutions are involved, which allows a wider population to participate in this research. The hospital center has a medical team consisting of nurses, TENS and doctors, etc., while biochemists, biologists, medical technologists and Researchers such as chemical pharmacists are also involved in sample analysis laboratories. The work performed in this type of scientific clinical research is joint and involves a variety of interdisciplinary capabilities that come together to allow these large-scale studies to be conducted.” IMII Dr. Susan Bueno, researcher and director of academics and science at UC. study.
Alexis Callergis stressed that “this type of collaborative work aims to strengthen our country’s scientific capabilities and directly and positively impact the health of citizens.”
Immunogenicity
Susan Bueno explained that the study was comparative because Sinovac’s quadrivalent vaccine was compared with a vaccine of equivalent coverage already registered in Chile and developed by another laboratory . “We evaluated the response of the vaccine developed with Sinovac against other alternatives, with the aim of determining that the results were comparable in terms of immunogenicity and safety to the already approved and registered vaccines (compared vaccines). In other words, we evaluated Does it generate neutralizing antibodies against the four strains of influenza virus,” noted the Ph.D. in Biomedical Sciences. This is done through laboratory testing.
In these studies, participants learn more about the study and sign a consent form. A small blood sample was taken from them and vaccinated, and they wrote a diary describing how they felt after being vaccinated. A month later, they were called in again to collect new blood samples to measure the antibodies produced by those who were immune.
infectious disease
Influenza is an infectious disease caused by a virus that spreads through coughing, sneezing or runny nose. Complications from the infection “may lead to hospitalization and even death; examples of serious complications include pneumonia and severe bronchitis,” the health ministry notes on its website.
As of August 19 this year, 6,598 people in Chile have been infected with the influenza virus, according to the Public Health Institute’s Report on Transmission of Respiratory Viruses. Among them, there were 5707 cases of influenza A and 891 cases of influenza B, which are the respiratory pathogens that will infect the largest number of people nationwide in 2023 after respiratory syncytial virus.
“Influenza viruses are constantly changing and different strains circulate each season, which is why the composition of the vaccine is modified each year to provide protection against strains that are more common in the South, according to the World Health Organization’s recommendations. .hemisphere, based on what happened the previous winter in the northern hemisphere”, says Dr. Pablo González.
The trivalent vaccine is the one used in the Chilean vaccination campaign and protects against three strains of the disease; usually there are two strains of influenza A and one strain of influenza B. Immunizations studied in Chile and the Philippines added protection against another strain of influenza B virus.
The free vaccination campaign in our country aims to prevent death and severe morbidity in those populations who are more at risk of complications or even death caused by or secondary to influenza virus infection. These include the elderly, patients with chronic diseases, medical personnel, children aged 6 months to 10 years, and pregnant women. Likewise, the strategies implemented are aimed at maintaining the integrity of care delivery.